Mental Health

For almost 2 decades, antidepressants have carried boxed warnings linking the medications to an increased risk for suicidal thoughts and behaviors in young people. Paradoxically, and for almost as long, evidence suggests these warnings may have led to fewer depression diagnoses, reduced prescriptions, and, ultimately, higher suicide rates.

With mounting evidence of these negative unintended consequences, some clinicians and researchers are urging the Food and Drug Administration (FDA) to consider revising — or even eliminating — boxed warnings on these medications.

The latest report challenging the utility of the 2005 warnings was particularly sobering. Published in October in Health Affairs, the systematic review of studies from 2003 to 2022 showed a 20%-40% decline in physician visits for depression, a 20%-50% decline in antidepressant use, and an abrupt increase in psychotropic drug poisonings and suicides — all after the warnings were added.

“FDA officials should review the totality of evidence and err on the side of caution in acknowledging possible harms of the antidepressant warnings,” lead author Stephen Soumerai, ScD, professor of population medicine at Harvard Medical School at Harvard Pilgrim Health Care Institute, Boston, Massachusetts and colleagues wrote. They called on the FDA to replace the boxed warnings with a routine warning in labeling.

While good prospective data on the risks and benefits of antidepressants in youth were limited when the boxed warnings were instituted, there is more information now, said Jeffrey Strawn, MD, professor of psychiatry and pediatrics at the University of Cincinnati College of Medicine in Ohio. Strawn, whose research on the topic has been cited frequently over the years, said the new evidence suggests it is time for the FDA to reevaluate the warnings.

“I don’t think that they’ve been useful. They’ve actually been harmful,” Strawn told this news organization. “These boxed warnings have decreased physicians’ and other clinicians’ comfort and tendency to prescribe.”

 

Decline in Diagnoses

The FDA issued its first warning about the potential for suicidal thoughts and behavior in children in 2003. After an advisory panel weighed the evidence, the agency added a boxed warning in 2005 to all antidepressants for children younger than 18 years. The warning was expanded in 2007 to include young adults through age 24.

Data suggesting that the warnings have had unintended effects can be found going back to just after they were issued. For instance, in 2009, after rising for years, the rate of new pediatric depression diagnoses fell precipitously after the warning was added, with primary care physicians diagnosing 44% fewer cases.

In 2014, citing evidence of fewer diagnoses and rising psychotropic drug poisonings, Weill Cornell Medicine Professor Richard A. Friedman, MD, called on the FDA in a perspective to remove the boxed warnings.

Strawn and colleagues reported in an often-cited 2014 systematic review and meta-analysis that, in nine trials involving 1673 patients and six medications, antidepressants were superior to placebo, with no increased risk for suicidal thoughts or behavior.

He has also studied adverse effects of the medications, reporting in Pharmacotherapy that suicidality risk might be more likely with some medications, such as paroxetine and venlafaxine, and that it could be influenced by baseline suicidality, among many other factors. A Swedish register study found that risk was highest the month before starting a medication, Strawn and colleagues wrote.

Dara Sakolsky, MD, PhD, associate professor of psychiatry and associate medical director, Services for Teens at Risk at the University of Pittsburgh School of Medicine, Pennsylvania, told this news organization that, because of “these negative unintended consequences,” the FDA should lower the temperature by putting the warnings in labeling.

“It makes sense based on the data that we have at hand now,” said Sakolsky.

 

The Dangers of Untreated Depression

Even with this new information, lingering concerns about earlier studies that pointed to increased suicidality risk may discourage prescribing by primary care physicians and pediatricians, and that worries researchers and psychiatrists.

“My concern is that the risk for suicide and suicidal behavior may be higher in untreated depression than the risk of suicidal thoughts or behaviors from antidepressants,” Jeffrey Bridge, PhD, director of the Center for Suicide Prevention and Research at Nationwide Children’s Hospital, Columbus, Ohio, told this news organization.

Bridge is the lead author of a much-cited 2007 meta-analysis in JAMA that showed that the benefits of antidepressants in children and adolescents appeared to be greater than the risks for suicidality. “The concern about antidepressants must be considered in the context of possible benefit,” wrote Bridge, who also is professor of pediatrics, psychiatry, and behavioral health at Ohio State University College of Medicine, Columbus.

Depression and suicide are a scourge for those younger than 25 years. A 2021 literature review noted that the prevalence of depression — which has been increasing for all Americans — has risen more among adolescents than adults. Depression is “strongly associated with suicide,” the authors wrote.

In 2021, the National Institute of Mental Health reported suicide was the second leading cause of death among 10- to 14-year-olds and the third leading cause of death among those aged 15-24 years.

Suicide kills more kids aged between 10 and 24 years than cancer and all other illnesses combined, John Campo, MD, director of child and adolescent psychiatry at Johns Hopkins University School of Medicine and vice president of psychiatric services at Kennedy Krieger Institute, told this news organization.

Meanwhile, he added, the medications work and clinicians balance risk and benefit in prescribing.

The landmark 2007 Treatment for Adolescents with Depression Study showed that fluoxetine, especially in combination with cognitive-behavioral therapy (CBT), was significantly better than placebo. Since that time, legions of trials have shown the drugs’ effectiveness.

The most effective treatment for teen depression is a combination of CBT and a selective serotonin reuptake inhibitor, said Sakolsky.

“We know that the evidence for that is pretty good,” she said. “On the flip side, we know the risk of having an adverse outcome is pretty low.”

Sakolsky tells patients and families that perhaps 1 in 146 will have a suicidal thought or behavior. “That’s pretty rare when we know how effective these medicines are.” 

Strawn said he always notes that no suicides took place in the trials that led to the warning and stresses that he closely monitors patients. “While the more recent prospective data are reassuring,” the suicidality risk “is something that we still talk about,” he said. He also discusses how some antidepressants seem to increase risk more than others.

For Campo, the discussion is based on his reading of the evidence, not the presence of the FDA warning.

“Based on what we know, I still think it’s fair to proceed with the idea that there is a small, but real risk,” he said. However, “at the same time, the medications might be exceptionally helpful for some kids.”

 

‘What Do We Do Now?’

When the FDA issued its warning in 2005, the agency said it identified the risk for suicidality in a combined analysis of short-term placebo-controlled trials of nine antidepressants. It ultimately included 24 trials involving more than 4400 patients. The risk was highest in the first few months. The average risk for those taking antidepressants was 4%, twice the placebo risk of 2%. There were no suicides in these trials, however.

The trials relied on spontaneous reports of adverse events, not predetermined measures, Campo said. Even so, that 2% difference is “nothing to sneeze at,” he noted.

Bridge’s meta-analysis showed a smaller difference — closer to 0.7%. “But it was still statistically significant,” Campo said. “I have trouble ignoring that.”

The unintended consequences of the warning can’t be studied in a randomized controlled trial. Studies have shown an association but not a direct cause-and-effect relationship between the warning and a decline in treatment and rise in suicides.

But the potential for suicidal thoughts and behavior with antidepressants has been studied prospectively. Some older studies found a significant risk, while more recent trials have not.

While the Health Affairs analysis “certainly makes a strong case,” it is observational data, Campo said.

“The question is, what do we do now in retrospect? Do you say, ‘Never mind. We don’t need the black box warning anymore?’ ” he said. “That would require a pretty careful look.”

The Health Affairs paper “makes me think that there are other areas of research that that need to be completed and done and updated, and then there should be an assessment, a reevaluation from the FDA,” said Bridge. A new meta-analysis “would be very informative,” he said.

 

What’s Next?

When asked about the Health Affairs paper and whether the agency would review the warnings, an FDA spokesperson told this news organization that the agency “does not comment on specific studies but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”

Sakolsky said the data clearly point to the damage that the warning has done over the past 2 decades, but that things might be improving. Studies conducted more recently might not have captured some changes in practice.

For instance, she noted, in 2022, the US Preventive Services Task Force recommended screening for major depressive disorder in adolescents aged 12-18 years. In turn, she has seen more patients in her office who were referred by pediatricians who had conducted the screening, said Sakolsky.

Strawn said the time for pontificating is long past due. “We’re withholding medications and other treatments that could potentially be effective for disorders that, in and of themselves, are associated with a significant increase in the risk of suicide.” 

After the FDA instituted the warning, “we were all very nervous,” about the potential fallout, said Campo, adding that a part of him wishes that the warnings had been “more mundane and less dramatic.”

Despite the unintended consequences, “it’s going to be hard to put the genie back in the bottle,” he said.

Campo and Sakolsky reported no relevant financial relationships. Strawn disclosed that his institution has received research funding from the National Institute of Child Health and Human Development, the Patient-Centered Outcomes Research Institute (PCORI), and AbbVie. Bridge reported that he received grant support from the National Institute of Mental Health, Centers for Disease Control and Prevention, and PCORI; is a scientific adviser to Clarigent Health; and is on the Scientific Council of the American Foundation for Suicide Prevention.

A version of this article first appeared on Medscape.com.

For almost 2 decades, antidepressants have carried boxed warnings linking the medications to an increased risk for suicidal thoughts and behaviors in young people. Paradoxically, and for almost as long, evidence suggests these warnings may have led to fewer depression diagnoses, reduced prescriptions, and, ultimately, higher suicide rates.

With mounting evidence of these negative unintended consequences, some clinicians and researchers are urging the Food and Drug Administration (FDA) to consider revising — or even eliminating — boxed warnings on these medications.

The latest report challenging the utility of the 2005 warnings was particularly sobering. Published in October in Health Affairs, the systematic review of studies from 2003 to 2022 showed a 20%-40% decline in physician visits for depression, a 20%-50% decline in antidepressant use, and an abrupt increase in psychotropic drug poisonings and suicides — all after the warnings were added.

“FDA officials should review the totality of evidence and err on the side of caution in acknowledging possible harms of the antidepressant warnings,” lead author Stephen Soumerai, ScD, professor of population medicine at Harvard Medical School at Harvard Pilgrim Health Care Institute, Boston, Massachusetts and colleagues wrote. They called on the FDA to replace the boxed warnings with a routine warning in labeling.

While good prospective data on the risks and benefits of antidepressants in youth were limited when the boxed warnings were instituted, there is more information now, said Jeffrey Strawn, MD, professor of psychiatry and pediatrics at the University of Cincinnati College of Medicine in Ohio. Strawn, whose research on the topic has been cited frequently over the years, said the new evidence suggests it is time for the FDA to reevaluate the warnings.

“I don’t think that they’ve been useful. They’ve actually been harmful,” Strawn told this news organization. “These boxed warnings have decreased physicians’ and other clinicians’ comfort and tendency to prescribe.”

 

Decline in Diagnoses

The FDA issued its first warning about the potential for suicidal thoughts and behavior in children in 2003. After an advisory panel weighed the evidence, the agency added a boxed warning in 2005 to all antidepressants for children younger than 18 years. The warning was expanded in 2007 to include young adults through age 24.

Data suggesting that the warnings have had unintended effects can be found going back to just after they were issued. For instance, in 2009, after rising for years, the rate of new pediatric depression diagnoses fell precipitously after the warning was added, with primary care physicians diagnosing 44% fewer cases.

In 2014, citing evidence of fewer diagnoses and rising psychotropic drug poisonings, Weill Cornell Medicine Professor Richard A. Friedman, MD, called on the FDA in a perspective to remove the boxed warnings.

Strawn and colleagues reported in an often-cited 2014 systematic review and meta-analysis that, in nine trials involving 1673 patients and six medications, antidepressants were superior to placebo, with no increased risk for suicidal thoughts or behavior.

He has also studied adverse effects of the medications, reporting in Pharmacotherapy that suicidality risk might be more likely with some medications, such as paroxetine and venlafaxine, and that it could be influenced by baseline suicidality, among many other factors. A Swedish register study found that risk was highest the month before starting a medication, Strawn and colleagues wrote.

Dara Sakolsky, MD, PhD, associate professor of psychiatry and associate medical director, Services for Teens at Risk at the University of Pittsburgh School of Medicine, Pennsylvania, told this news organization that, because of “these negative unintended consequences,” the FDA should lower the temperature by putting the warnings in labeling.

“It makes sense based on the data that we have at hand now,” said Sakolsky.

 

The Dangers of Untreated Depression

Even with this new information, lingering concerns about earlier studies that pointed to increased suicidality risk may discourage prescribing by primary care physicians and pediatricians, and that worries researchers and psychiatrists.

“My concern is that the risk for suicide and suicidal behavior may be higher in untreated depression than the risk of suicidal thoughts or behaviors from antidepressants,” Jeffrey Bridge, PhD, director of the Center for Suicide Prevention and Research at Nationwide Children’s Hospital, Columbus, Ohio, told this news organization.

Bridge is the lead author of a much-cited 2007 meta-analysis in JAMA that showed that the benefits of antidepressants in children and adolescents appeared to be greater than the risks for suicidality. “The concern about antidepressants must be considered in the context of possible benefit,” wrote Bridge, who also is professor of pediatrics, psychiatry, and behavioral health at Ohio State University College of Medicine, Columbus.

Depression and suicide are a scourge for those younger than 25 years. A 2021 literature review noted that the prevalence of depression — which has been increasing for all Americans — has risen more among adolescents than adults. Depression is “strongly associated with suicide,” the authors wrote.

In 2021, the National Institute of Mental Health reported suicide was the second leading cause of death among 10- to 14-year-olds and the third leading cause of death among those aged 15-24 years.

Suicide kills more kids aged between 10 and 24 years than cancer and all other illnesses combined, John Campo, MD, director of child and adolescent psychiatry at Johns Hopkins University School of Medicine and vice president of psychiatric services at Kennedy Krieger Institute, told this news organization.

Meanwhile, he added, the medications work and clinicians balance risk and benefit in prescribing.

The landmark 2007 Treatment for Adolescents with Depression Study showed that fluoxetine, especially in combination with cognitive-behavioral therapy (CBT), was significantly better than placebo. Since that time, legions of trials have shown the drugs’ effectiveness.

The most effective treatment for teen depression is a combination of CBT and a selective serotonin reuptake inhibitor, said Sakolsky.

“We know that the evidence for that is pretty good,” she said. “On the flip side, we know the risk of having an adverse outcome is pretty low.”

Sakolsky tells patients and families that perhaps 1 in 146 will have a suicidal thought or behavior. “That’s pretty rare when we know how effective these medicines are.” 

Strawn said he always notes that no suicides took place in the trials that led to the warning and stresses that he closely monitors patients. “While the more recent prospective data are reassuring,” the suicidality risk “is something that we still talk about,” he said. He also discusses how some antidepressants seem to increase risk more than others.

For Campo, the discussion is based on his reading of the evidence, not the presence of the FDA warning.

“Based on what we know, I still think it’s fair to proceed with the idea that there is a small, but real risk,” he said. However, “at the same time, the medications might be exceptionally helpful for some kids.”

 

‘What Do We Do Now?’

When the FDA issued its warning in 2005, the agency said it identified the risk for suicidality in a combined analysis of short-term placebo-controlled trials of nine antidepressants. It ultimately included 24 trials involving more than 4400 patients. The risk was highest in the first few months. The average risk for those taking antidepressants was 4%, twice the placebo risk of 2%. There were no suicides in these trials, however.

The trials relied on spontaneous reports of adverse events, not predetermined measures, Campo said. Even so, that 2% difference is “nothing to sneeze at,” he noted.

Bridge’s meta-analysis showed a smaller difference — closer to 0.7%. “But it was still statistically significant,” Campo said. “I have trouble ignoring that.”

The unintended consequences of the warning can’t be studied in a randomized controlled trial. Studies have shown an association but not a direct cause-and-effect relationship between the warning and a decline in treatment and rise in suicides.

But the potential for suicidal thoughts and behavior with antidepressants has been studied prospectively. Some older studies found a significant risk, while more recent trials have not.

While the Health Affairs analysis “certainly makes a strong case,” it is observational data, Campo said.

“The question is, what do we do now in retrospect? Do you say, ‘Never mind. We don’t need the black box warning anymore?’ ” he said. “That would require a pretty careful look.”

The Health Affairs paper “makes me think that there are other areas of research that that need to be completed and done and updated, and then there should be an assessment, a reevaluation from the FDA,” said Bridge. A new meta-analysis “would be very informative,” he said.

 

What’s Next?

When asked about the Health Affairs paper and whether the agency would review the warnings, an FDA spokesperson told this news organization that the agency “does not comment on specific studies but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”

Sakolsky said the data clearly point to the damage that the warning has done over the past 2 decades, but that things might be improving. Studies conducted more recently might not have captured some changes in practice.

For instance, she noted, in 2022, the US Preventive Services Task Force recommended screening for major depressive disorder in adolescents aged 12-18 years. In turn, she has seen more patients in her office who were referred by pediatricians who had conducted the screening, said Sakolsky.

Strawn said the time for pontificating is long past due. “We’re withholding medications and other treatments that could potentially be effective for disorders that, in and of themselves, are associated with a significant increase in the risk of suicide.” 

After the FDA instituted the warning, “we were all very nervous,” about the potential fallout, said Campo, adding that a part of him wishes that the warnings had been “more mundane and less dramatic.”

Despite the unintended consequences, “it’s going to be hard to put the genie back in the bottle,” he said.

Campo and Sakolsky reported no relevant financial relationships. Strawn disclosed that his institution has received research funding from the National Institute of Child Health and Human Development, the Patient-Centered Outcomes Research Institute (PCORI), and AbbVie. Bridge reported that he received grant support from the National Institute of Mental Health, Centers for Disease Control and Prevention, and PCORI; is a scientific adviser to Clarigent Health; and is on the Scientific Council of the American Foundation for Suicide Prevention.

A version of this article first appeared on Medscape.com.

For almost 2 decades, antidepressants have carried boxed warnings linking the medications to an increased risk for suicidal thoughts and behaviors in young people. Paradoxically, and for almost as long, evidence suggests these warnings may have led to fewer depression diagnoses, reduced prescriptions, and, ultimately, higher suicide rates.

With mounting evidence of these negative unintended consequences, some clinicians and researchers are urging the Food and Drug Administration (FDA) to consider revising — or even eliminating — boxed warnings on these medications.

The latest report challenging the utility of the 2005 warnings was particularly sobering. Published in October in Health Affairs, the systematic review of studies from 2003 to 2022 showed a 20%-40% decline in physician visits for depression, a 20%-50% decline in antidepressant use, and an abrupt increase in psychotropic drug poisonings and suicides — all after the warnings were added.

“FDA officials should review the totality of evidence and err on the side of caution in acknowledging possible harms of the antidepressant warnings,” lead author Stephen Soumerai, ScD, professor of population medicine at Harvard Medical School at Harvard Pilgrim Health Care Institute, Boston, Massachusetts and colleagues wrote. They called on the FDA to replace the boxed warnings with a routine warning in labeling.

While good prospective data on the risks and benefits of antidepressants in youth were limited when the boxed warnings were instituted, there is more information now, said Jeffrey Strawn, MD, professor of psychiatry and pediatrics at the University of Cincinnati College of Medicine in Ohio. Strawn, whose research on the topic has been cited frequently over the years, said the new evidence suggests it is time for the FDA to reevaluate the warnings.

“I don’t think that they’ve been useful. They’ve actually been harmful,” Strawn told this news organization. “These boxed warnings have decreased physicians’ and other clinicians’ comfort and tendency to prescribe.”

 

Decline in Diagnoses

The FDA issued its first warning about the potential for suicidal thoughts and behavior in children in 2003. After an advisory panel weighed the evidence, the agency added a boxed warning in 2005 to all antidepressants for children younger than 18 years. The warning was expanded in 2007 to include young adults through age 24.

Data suggesting that the warnings have had unintended effects can be found going back to just after they were issued. For instance, in 2009, after rising for years, the rate of new pediatric depression diagnoses fell precipitously after the warning was added, with primary care physicians diagnosing 44% fewer cases.

In 2014, citing evidence of fewer diagnoses and rising psychotropic drug poisonings, Weill Cornell Medicine Professor Richard A. Friedman, MD, called on the FDA in a perspective to remove the boxed warnings.

Strawn and colleagues reported in an often-cited 2014 systematic review and meta-analysis that, in nine trials involving 1673 patients and six medications, antidepressants were superior to placebo, with no increased risk for suicidal thoughts or behavior.

He has also studied adverse effects of the medications, reporting in Pharmacotherapy that suicidality risk might be more likely with some medications, such as paroxetine and venlafaxine, and that it could be influenced by baseline suicidality, among many other factors. A Swedish register study found that risk was highest the month before starting a medication, Strawn and colleagues wrote.

Dara Sakolsky, MD, PhD, associate professor of psychiatry and associate medical director, Services for Teens at Risk at the University of Pittsburgh School of Medicine, Pennsylvania, told this news organization that, because of “these negative unintended consequences,” the FDA should lower the temperature by putting the warnings in labeling.

“It makes sense based on the data that we have at hand now,” said Sakolsky.

 

The Dangers of Untreated Depression

Even with this new information, lingering concerns about earlier studies that pointed to increased suicidality risk may discourage prescribing by primary care physicians and pediatricians, and that worries researchers and psychiatrists.

“My concern is that the risk for suicide and suicidal behavior may be higher in untreated depression than the risk of suicidal thoughts or behaviors from antidepressants,” Jeffrey Bridge, PhD, director of the Center for Suicide Prevention and Research at Nationwide Children’s Hospital, Columbus, Ohio, told this news organization.

Bridge is the lead author of a much-cited 2007 meta-analysis in JAMA that showed that the benefits of antidepressants in children and adolescents appeared to be greater than the risks for suicidality. “The concern about antidepressants must be considered in the context of possible benefit,” wrote Bridge, who also is professor of pediatrics, psychiatry, and behavioral health at Ohio State University College of Medicine, Columbus.

Depression and suicide are a scourge for those younger than 25 years. A 2021 literature review noted that the prevalence of depression — which has been increasing for all Americans — has risen more among adolescents than adults. Depression is “strongly associated with suicide,” the authors wrote.

In 2021, the National Institute of Mental Health reported suicide was the second leading cause of death among 10- to 14-year-olds and the third leading cause of death among those aged 15-24 years.

Suicide kills more kids aged between 10 and 24 years than cancer and all other illnesses combined, John Campo, MD, director of child and adolescent psychiatry at Johns Hopkins University School of Medicine and vice president of psychiatric services at Kennedy Krieger Institute, told this news organization.

Meanwhile, he added, the medications work and clinicians balance risk and benefit in prescribing.

The landmark 2007 Treatment for Adolescents with Depression Study showed that fluoxetine, especially in combination with cognitive-behavioral therapy (CBT), was significantly better than placebo. Since that time, legions of trials have shown the drugs’ effectiveness.

The most effective treatment for teen depression is a combination of CBT and a selective serotonin reuptake inhibitor, said Sakolsky.

“We know that the evidence for that is pretty good,” she said. “On the flip side, we know the risk of having an adverse outcome is pretty low.”

Sakolsky tells patients and families that perhaps 1 in 146 will have a suicidal thought or behavior. “That’s pretty rare when we know how effective these medicines are.” 

Strawn said he always notes that no suicides took place in the trials that led to the warning and stresses that he closely monitors patients. “While the more recent prospective data are reassuring,” the suicidality risk “is something that we still talk about,” he said. He also discusses how some antidepressants seem to increase risk more than others.

For Campo, the discussion is based on his reading of the evidence, not the presence of the FDA warning.

“Based on what we know, I still think it’s fair to proceed with the idea that there is a small, but real risk,” he said. However, “at the same time, the medications might be exceptionally helpful for some kids.”

 

‘What Do We Do Now?’

When the FDA issued its warning in 2005, the agency said it identified the risk for suicidality in a combined analysis of short-term placebo-controlled trials of nine antidepressants. It ultimately included 24 trials involving more than 4400 patients. The risk was highest in the first few months. The average risk for those taking antidepressants was 4%, twice the placebo risk of 2%. There were no suicides in these trials, however.

The trials relied on spontaneous reports of adverse events, not predetermined measures, Campo said. Even so, that 2% difference is “nothing to sneeze at,” he noted.

Bridge’s meta-analysis showed a smaller difference — closer to 0.7%. “But it was still statistically significant,” Campo said. “I have trouble ignoring that.”

The unintended consequences of the warning can’t be studied in a randomized controlled trial. Studies have shown an association but not a direct cause-and-effect relationship between the warning and a decline in treatment and rise in suicides.

But the potential for suicidal thoughts and behavior with antidepressants has been studied prospectively. Some older studies found a significant risk, while more recent trials have not.

While the Health Affairs analysis “certainly makes a strong case,” it is observational data, Campo said.

“The question is, what do we do now in retrospect? Do you say, ‘Never mind. We don’t need the black box warning anymore?’ ” he said. “That would require a pretty careful look.”

The Health Affairs paper “makes me think that there are other areas of research that that need to be completed and done and updated, and then there should be an assessment, a reevaluation from the FDA,” said Bridge. A new meta-analysis “would be very informative,” he said.

 

What’s Next?

When asked about the Health Affairs paper and whether the agency would review the warnings, an FDA spokesperson told this news organization that the agency “does not comment on specific studies but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”

Sakolsky said the data clearly point to the damage that the warning has done over the past 2 decades, but that things might be improving. Studies conducted more recently might not have captured some changes in practice.

For instance, she noted, in 2022, the US Preventive Services Task Force recommended screening for major depressive disorder in adolescents aged 12-18 years. In turn, she has seen more patients in her office who were referred by pediatricians who had conducted the screening, said Sakolsky.

Strawn said the time for pontificating is long past due. “We’re withholding medications and other treatments that could potentially be effective for disorders that, in and of themselves, are associated with a significant increase in the risk of suicide.” 

After the FDA instituted the warning, “we were all very nervous,” about the potential fallout, said Campo, adding that a part of him wishes that the warnings had been “more mundane and less dramatic.”

Despite the unintended consequences, “it’s going to be hard to put the genie back in the bottle,” he said.

Campo and Sakolsky reported no relevant financial relationships. Strawn disclosed that his institution has received research funding from the National Institute of Child Health and Human Development, the Patient-Centered Outcomes Research Institute (PCORI), and AbbVie. Bridge reported that he received grant support from the National Institute of Mental Health, Centers for Disease Control and Prevention, and PCORI; is a scientific adviser to Clarigent Health; and is on the Scientific Council of the American Foundation for Suicide Prevention.

A version of this article first appeared on Medscape.com.

A drug that combines the atypical antipsychotic brexpiprazole and the selective serotonin reuptake inhibitor sertraline provides significantly greater relief of posttraumatic stress disorder (PTSD) symptoms than sertraline plus placebo, results of a phase 3 trial showed.

The medication is currently under review by the Food and Drug Administration (FDA) and if approved, will be the first pharmacologic option for PTSD in more than 20 years.

The trial met its primary endpoint of change in the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) (CAPS-5) total score at week 10 and secondary patient-reported outcomes of PTSD symptoms, anxiety, and depression.

“And what is really cool, what’s really impactful is the combination worked better than sertraline plus placebo on a brief inventory of psychosocial functioning,” study investigator Lori L. Davis, a senior research psychiatrist, Birmingham Veterans Affairs Health Care System in Alabama, said in an interview.

“We can treat symptoms but that’s where the rubber meets the road, in terms of are they functioning better,” added Davis, who is also an adjunct professor of psychiatry, Heersink School of Medicine, University of Alabama at Birmingham.

The findings were published online on December 18 in JAMA Psychiatry and reported in May 2024 as part of a trio of trials conducted by Otsuka Pharmaceutical and Lundbeck Pharmaceuticals, codevelopers of the drug.

 

Clinically Meaningful

The FDA accepted the companies’ supplemental new drug application in June with a decision on approval expected in early February 2025.

“This study provides promising results for a medication that may be an important new option for PTSD,” John Krystal, MD, director, Clinical Neuroscience Division, National Center for PTSD, US Department of Veterans Affairs, who was not involved in the research, said in an interview. “New PTSD treatments are a high priority.”

Currently, there are two FDA-approved medication treatments for PTSD — sertraline and paroxetine.

“They are helpful for many people, but patients are often left with residual symptoms or tolerability issues,” noted Krystal, who is also professor and chair of psychiatry, Yale University, New Haven, Connecticut.

“New medications that might address the important ‘effectiveness gap’ in PTSD could help to reduce the remaining distress, disability, and suicide risk associated with PTSD.” 

The double-blind, phase 3 trial included 416 adults aged 18-65 years with a DSM-5 diagnosis of PTSD and symptoms for at least 6 months prior to screening. Patients underwent a 1-week placebo-run in period followed by randomization to daily oral brexpiprazole 2-3 mg plus sertraline 150 mg or daily sertraline 150 mg plus placebo for 11 weeks.

Participants’ mean age was 37.4 years, 74.5% were women, and mean CAPS-5 total score was 38.4, suggesting moderate to high severity PTSD, Davis said. The average time from the index traumatic event was 4 years and three fourths had no prior exposure to PTSD prescription medications.

At week 10, the mean change in CAPS-5 score from randomization was –19.2 points in the brexpiprazole plus sertraline group and –13.6 points in the sertraline plus placebo group (95% CI, –8.79 to –2.38; P < .001).

Asked whether the 5.59-point treatment difference is clinically meaningful, Davis said there is no widely agreed definition for change in CAPS-5 total score but that a within-group reduction of more than 10-13 points is most-often cited as being clinically meaningful.

The key secondary endpoint of least square mean change in the patient-reported Brief Inventory of Psychosocial Function total score from baseline to week 12 was –33.8 with the combination vs –21.8 with sertraline plus placebo (95% CI, –19.4 to –4.62; P = .002).

“That’s clinically meaningful for me as a provider and a clinician and a researcher when you’re getting the PTSD symptom change differences in parallel with the improvement in functional outcome,” she said. “I see that as the clinically meaningful gauge.”

In terms of safety, 3.9% of the participants in the brexpiprazole/sertraline group and 10.2% of those in the sertraline/placebo group discontinued treatment because of adverse events.

In both the combination and control groups, the only treatment-emergent adverse event with an incidence of more than 10% was nausea (12.2% vs 11.7%, respectively).

At the last visit, the mean change in body weight from baseline was an increase of 1.3 kg for brexpiprazole plus sertraline vs 0 kg for sertraline alone. Rates of fatigue (6.8% vs 4.1%) and somnolence (5.4% vs 2.6%) were also higher with brexpiprazole plus sertraline.

 

A Trio of Clinical Trials

The findings are part of a larger program reported by the drug makers that includes a flexible-dose brexpiprazole phase 2 trial that met the same CAPS-5 primary endpoint and a second phase 3 trial (072 study) that did not.

“We’ve looked at that data and the sertraline/placebo response was a lot higher, so it was not due to a lack of response with the combination but due to a more robust response with the active control,” Davis said. “But we want to point out for that 072 study, there was still important separation between the combination and sertraline plus placebo on the functional outcome.”

All three trials ran for 12 weeks, so longer-term efficacy and safety data are needed, she said. Other limitations of the published phase 3 study are the patient eligibility criteria, restrictions on concomitant therapy, and lack of non-US sites, which many limit generalizability, the authors noted.

“Specifically, the exclusion of patients with a current major depressive episode is both a strength (to show a specific effect on PTSD) and a limitation (given the high prevalence of comorbid depression in PTSD),” they added.

 

Kudos, Caveats

Reached for comment, Vincent F. Capaldi, II, MD, ScM, professor and chair, department of psychiatry, Uniformed Services University of the Health Sciences School of Medicine, Bethesda, Maryland, said the exclusion of these patients is a limitation but that the study was well designed and conducted in a large sample across the United States.

“The findings suggest that brexpiprazole plus sertraline is a more effective treatment for PTSD than sertraline alone,” he said. “This finding is significant for our service members, who suffer from PTSD at higher rates than the general population.”

Additionally, the significant improvement in psychosocial functioning at week 12 “is important because PTSD is known to cause significant social and occupational disability, as well as quality-of-life issues,” he said.

Capaldi pointed out, however, that the study was conducted only at US sites and did not specifically target military/veteran persons, which may limit applicability to these unique populations.

“While subgroup analyses were generally consistent with the primary analysis, the study was not powered to detect differences between subgroups,” he added. “These subgroup analyses are quite important when considering military and veteran populations.”

Further research is needed to explore whether certain traumas are more responsive to combination treatment, the efficacy of augmenting existing sertraline therapy, and the specific mechanisms of brexpiprazole driving the improved outcomes, Capaldi said.

This study was funded by Otsuka Pharmaceutical Development & Commercialization, which was involved in the design, conduct, and data analysis. Davis reported receiving advisory board fees from Otsuka and Boehringer Ingelheim; lecture fees from Clinical Care Options; and grants from Alkermes, the Veterans Affairs, Patient-Centered Outcomes Research Institute, Department of Defense, and Social Finance. Several coauthors are employees of Otsuka. Krystal reported serving as a consultant for Otsuka America Pharmaceutical, Aptinyx, Biogen, IDEC, Bionomics, Boehringer Ingelheim International, Clearmind Medicine, Cybin IRL, Enveric Biosciences, Epiodyne, EpiVario, Janssen, Jazz Pharmaceuticals, Perception Neuroscience, Praxis Precision Medicines, Springcare, and Sunovion Pharmaceuticals. Krystal also reported serving as a scientific advisory board member for several companies and holding several patents.

A version of this article appeared on Medscape.com.

A drug that combines the atypical antipsychotic brexpiprazole and the selective serotonin reuptake inhibitor sertraline provides significantly greater relief of posttraumatic stress disorder (PTSD) symptoms than sertraline plus placebo, results of a phase 3 trial showed.

The medication is currently under review by the Food and Drug Administration (FDA) and if approved, will be the first pharmacologic option for PTSD in more than 20 years.

The trial met its primary endpoint of change in the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) (CAPS-5) total score at week 10 and secondary patient-reported outcomes of PTSD symptoms, anxiety, and depression.

“And what is really cool, what’s really impactful is the combination worked better than sertraline plus placebo on a brief inventory of psychosocial functioning,” study investigator Lori L. Davis, a senior research psychiatrist, Birmingham Veterans Affairs Health Care System in Alabama, said in an interview.

“We can treat symptoms but that’s where the rubber meets the road, in terms of are they functioning better,” added Davis, who is also an adjunct professor of psychiatry, Heersink School of Medicine, University of Alabama at Birmingham.

The findings were published online on December 18 in JAMA Psychiatry and reported in May 2024 as part of a trio of trials conducted by Otsuka Pharmaceutical and Lundbeck Pharmaceuticals, codevelopers of the drug.

 

Clinically Meaningful

The FDA accepted the companies’ supplemental new drug application in June with a decision on approval expected in early February 2025.

“This study provides promising results for a medication that may be an important new option for PTSD,” John Krystal, MD, director, Clinical Neuroscience Division, National Center for PTSD, US Department of Veterans Affairs, who was not involved in the research, said in an interview. “New PTSD treatments are a high priority.”

Currently, there are two FDA-approved medication treatments for PTSD — sertraline and paroxetine.

“They are helpful for many people, but patients are often left with residual symptoms or tolerability issues,” noted Krystal, who is also professor and chair of psychiatry, Yale University, New Haven, Connecticut.

“New medications that might address the important ‘effectiveness gap’ in PTSD could help to reduce the remaining distress, disability, and suicide risk associated with PTSD.” 

The double-blind, phase 3 trial included 416 adults aged 18-65 years with a DSM-5 diagnosis of PTSD and symptoms for at least 6 months prior to screening. Patients underwent a 1-week placebo-run in period followed by randomization to daily oral brexpiprazole 2-3 mg plus sertraline 150 mg or daily sertraline 150 mg plus placebo for 11 weeks.

Participants’ mean age was 37.4 years, 74.5% were women, and mean CAPS-5 total score was 38.4, suggesting moderate to high severity PTSD, Davis said. The average time from the index traumatic event was 4 years and three fourths had no prior exposure to PTSD prescription medications.

At week 10, the mean change in CAPS-5 score from randomization was –19.2 points in the brexpiprazole plus sertraline group and –13.6 points in the sertraline plus placebo group (95% CI, –8.79 to –2.38; P < .001).

Asked whether the 5.59-point treatment difference is clinically meaningful, Davis said there is no widely agreed definition for change in CAPS-5 total score but that a within-group reduction of more than 10-13 points is most-often cited as being clinically meaningful.

The key secondary endpoint of least square mean change in the patient-reported Brief Inventory of Psychosocial Function total score from baseline to week 12 was –33.8 with the combination vs –21.8 with sertraline plus placebo (95% CI, –19.4 to –4.62; P = .002).

“That’s clinically meaningful for me as a provider and a clinician and a researcher when you’re getting the PTSD symptom change differences in parallel with the improvement in functional outcome,” she said. “I see that as the clinically meaningful gauge.”

In terms of safety, 3.9% of the participants in the brexpiprazole/sertraline group and 10.2% of those in the sertraline/placebo group discontinued treatment because of adverse events.

In both the combination and control groups, the only treatment-emergent adverse event with an incidence of more than 10% was nausea (12.2% vs 11.7%, respectively).

At the last visit, the mean change in body weight from baseline was an increase of 1.3 kg for brexpiprazole plus sertraline vs 0 kg for sertraline alone. Rates of fatigue (6.8% vs 4.1%) and somnolence (5.4% vs 2.6%) were also higher with brexpiprazole plus sertraline.

 

A Trio of Clinical Trials

The findings are part of a larger program reported by the drug makers that includes a flexible-dose brexpiprazole phase 2 trial that met the same CAPS-5 primary endpoint and a second phase 3 trial (072 study) that did not.

“We’ve looked at that data and the sertraline/placebo response was a lot higher, so it was not due to a lack of response with the combination but due to a more robust response with the active control,” Davis said. “But we want to point out for that 072 study, there was still important separation between the combination and sertraline plus placebo on the functional outcome.”

All three trials ran for 12 weeks, so longer-term efficacy and safety data are needed, she said. Other limitations of the published phase 3 study are the patient eligibility criteria, restrictions on concomitant therapy, and lack of non-US sites, which many limit generalizability, the authors noted.

“Specifically, the exclusion of patients with a current major depressive episode is both a strength (to show a specific effect on PTSD) and a limitation (given the high prevalence of comorbid depression in PTSD),” they added.

 

Kudos, Caveats

Reached for comment, Vincent F. Capaldi, II, MD, ScM, professor and chair, department of psychiatry, Uniformed Services University of the Health Sciences School of Medicine, Bethesda, Maryland, said the exclusion of these patients is a limitation but that the study was well designed and conducted in a large sample across the United States.

“The findings suggest that brexpiprazole plus sertraline is a more effective treatment for PTSD than sertraline alone,” he said. “This finding is significant for our service members, who suffer from PTSD at higher rates than the general population.”

Additionally, the significant improvement in psychosocial functioning at week 12 “is important because PTSD is known to cause significant social and occupational disability, as well as quality-of-life issues,” he said.

Capaldi pointed out, however, that the study was conducted only at US sites and did not specifically target military/veteran persons, which may limit applicability to these unique populations.

“While subgroup analyses were generally consistent with the primary analysis, the study was not powered to detect differences between subgroups,” he added. “These subgroup analyses are quite important when considering military and veteran populations.”

Further research is needed to explore whether certain traumas are more responsive to combination treatment, the efficacy of augmenting existing sertraline therapy, and the specific mechanisms of brexpiprazole driving the improved outcomes, Capaldi said.

This study was funded by Otsuka Pharmaceutical Development & Commercialization, which was involved in the design, conduct, and data analysis. Davis reported receiving advisory board fees from Otsuka and Boehringer Ingelheim; lecture fees from Clinical Care Options; and grants from Alkermes, the Veterans Affairs, Patient-Centered Outcomes Research Institute, Department of Defense, and Social Finance. Several coauthors are employees of Otsuka. Krystal reported serving as a consultant for Otsuka America Pharmaceutical, Aptinyx, Biogen, IDEC, Bionomics, Boehringer Ingelheim International, Clearmind Medicine, Cybin IRL, Enveric Biosciences, Epiodyne, EpiVario, Janssen, Jazz Pharmaceuticals, Perception Neuroscience, Praxis Precision Medicines, Springcare, and Sunovion Pharmaceuticals. Krystal also reported serving as a scientific advisory board member for several companies and holding several patents.

A version of this article appeared on Medscape.com.

A drug that combines the atypical antipsychotic brexpiprazole and the selective serotonin reuptake inhibitor sertraline provides significantly greater relief of posttraumatic stress disorder (PTSD) symptoms than sertraline plus placebo, results of a phase 3 trial showed.

The medication is currently under review by the Food and Drug Administration (FDA) and if approved, will be the first pharmacologic option for PTSD in more than 20 years.

The trial met its primary endpoint of change in the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) (CAPS-5) total score at week 10 and secondary patient-reported outcomes of PTSD symptoms, anxiety, and depression.

“And what is really cool, what’s really impactful is the combination worked better than sertraline plus placebo on a brief inventory of psychosocial functioning,” study investigator Lori L. Davis, a senior research psychiatrist, Birmingham Veterans Affairs Health Care System in Alabama, said in an interview.

“We can treat symptoms but that’s where the rubber meets the road, in terms of are they functioning better,” added Davis, who is also an adjunct professor of psychiatry, Heersink School of Medicine, University of Alabama at Birmingham.

The findings were published online on December 18 in JAMA Psychiatry and reported in May 2024 as part of a trio of trials conducted by Otsuka Pharmaceutical and Lundbeck Pharmaceuticals, codevelopers of the drug.

 

Clinically Meaningful

The FDA accepted the companies’ supplemental new drug application in June with a decision on approval expected in early February 2025.

“This study provides promising results for a medication that may be an important new option for PTSD,” John Krystal, MD, director, Clinical Neuroscience Division, National Center for PTSD, US Department of Veterans Affairs, who was not involved in the research, said in an interview. “New PTSD treatments are a high priority.”

Currently, there are two FDA-approved medication treatments for PTSD — sertraline and paroxetine.

“They are helpful for many people, but patients are often left with residual symptoms or tolerability issues,” noted Krystal, who is also professor and chair of psychiatry, Yale University, New Haven, Connecticut.

“New medications that might address the important ‘effectiveness gap’ in PTSD could help to reduce the remaining distress, disability, and suicide risk associated with PTSD.” 

The double-blind, phase 3 trial included 416 adults aged 18-65 years with a DSM-5 diagnosis of PTSD and symptoms for at least 6 months prior to screening. Patients underwent a 1-week placebo-run in period followed by randomization to daily oral brexpiprazole 2-3 mg plus sertraline 150 mg or daily sertraline 150 mg plus placebo for 11 weeks.

Participants’ mean age was 37.4 years, 74.5% were women, and mean CAPS-5 total score was 38.4, suggesting moderate to high severity PTSD, Davis said. The average time from the index traumatic event was 4 years and three fourths had no prior exposure to PTSD prescription medications.

At week 10, the mean change in CAPS-5 score from randomization was –19.2 points in the brexpiprazole plus sertraline group and –13.6 points in the sertraline plus placebo group (95% CI, –8.79 to –2.38; P < .001).

Asked whether the 5.59-point treatment difference is clinically meaningful, Davis said there is no widely agreed definition for change in CAPS-5 total score but that a within-group reduction of more than 10-13 points is most-often cited as being clinically meaningful.

The key secondary endpoint of least square mean change in the patient-reported Brief Inventory of Psychosocial Function total score from baseline to week 12 was –33.8 with the combination vs –21.8 with sertraline plus placebo (95% CI, –19.4 to –4.62; P = .002).

“That’s clinically meaningful for me as a provider and a clinician and a researcher when you’re getting the PTSD symptom change differences in parallel with the improvement in functional outcome,” she said. “I see that as the clinically meaningful gauge.”

In terms of safety, 3.9% of the participants in the brexpiprazole/sertraline group and 10.2% of those in the sertraline/placebo group discontinued treatment because of adverse events.

In both the combination and control groups, the only treatment-emergent adverse event with an incidence of more than 10% was nausea (12.2% vs 11.7%, respectively).

At the last visit, the mean change in body weight from baseline was an increase of 1.3 kg for brexpiprazole plus sertraline vs 0 kg for sertraline alone. Rates of fatigue (6.8% vs 4.1%) and somnolence (5.4% vs 2.6%) were also higher with brexpiprazole plus sertraline.

 

A Trio of Clinical Trials

The findings are part of a larger program reported by the drug makers that includes a flexible-dose brexpiprazole phase 2 trial that met the same CAPS-5 primary endpoint and a second phase 3 trial (072 study) that did not.

“We’ve looked at that data and the sertraline/placebo response was a lot higher, so it was not due to a lack of response with the combination but due to a more robust response with the active control,” Davis said. “But we want to point out for that 072 study, there was still important separation between the combination and sertraline plus placebo on the functional outcome.”

All three trials ran for 12 weeks, so longer-term efficacy and safety data are needed, she said. Other limitations of the published phase 3 study are the patient eligibility criteria, restrictions on concomitant therapy, and lack of non-US sites, which many limit generalizability, the authors noted.

“Specifically, the exclusion of patients with a current major depressive episode is both a strength (to show a specific effect on PTSD) and a limitation (given the high prevalence of comorbid depression in PTSD),” they added.

 

Kudos, Caveats

Reached for comment, Vincent F. Capaldi, II, MD, ScM, professor and chair, department of psychiatry, Uniformed Services University of the Health Sciences School of Medicine, Bethesda, Maryland, said the exclusion of these patients is a limitation but that the study was well designed and conducted in a large sample across the United States.

“The findings suggest that brexpiprazole plus sertraline is a more effective treatment for PTSD than sertraline alone,” he said. “This finding is significant for our service members, who suffer from PTSD at higher rates than the general population.”

Additionally, the significant improvement in psychosocial functioning at week 12 “is important because PTSD is known to cause significant social and occupational disability, as well as quality-of-life issues,” he said.

Capaldi pointed out, however, that the study was conducted only at US sites and did not specifically target military/veteran persons, which may limit applicability to these unique populations.

“While subgroup analyses were generally consistent with the primary analysis, the study was not powered to detect differences between subgroups,” he added. “These subgroup analyses are quite important when considering military and veteran populations.”

Further research is needed to explore whether certain traumas are more responsive to combination treatment, the efficacy of augmenting existing sertraline therapy, and the specific mechanisms of brexpiprazole driving the improved outcomes, Capaldi said.

This study was funded by Otsuka Pharmaceutical Development & Commercialization, which was involved in the design, conduct, and data analysis. Davis reported receiving advisory board fees from Otsuka and Boehringer Ingelheim; lecture fees from Clinical Care Options; and grants from Alkermes, the Veterans Affairs, Patient-Centered Outcomes Research Institute, Department of Defense, and Social Finance. Several coauthors are employees of Otsuka. Krystal reported serving as a consultant for Otsuka America Pharmaceutical, Aptinyx, Biogen, IDEC, Bionomics, Boehringer Ingelheim International, Clearmind Medicine, Cybin IRL, Enveric Biosciences, Epiodyne, EpiVario, Janssen, Jazz Pharmaceuticals, Perception Neuroscience, Praxis Precision Medicines, Springcare, and Sunovion Pharmaceuticals. Krystal also reported serving as a scientific advisory board member for several companies and holding several patents.

A version of this article appeared on Medscape.com.

Of all the currently available pharmacological and nonpharmacological therapies for attention deficit and hyperactivity disorder (ADHD) in adults, only stimulants and atomoxetine are effective at reducing core symptoms, results of a large comprehensive meta-analysis showed.

The study of 113 randomized controlled trials with nearly 15,000 adults with a formal diagnosis of ADHD also revealed that atomoxetine is less acceptable to patients and that results of efficacy of nonpharmacological strategies are inconsistent.

Data on long-term efficacy of ADHD therapies are lacking, investigators noted, so these results only apply to short-term efficacy.

“There is a lot of controversy about medication, so these are quite reassuring data and certainly reinforce the role of medication as a treatment for ADHD,” study investigator Samuele Cortese, MD, PhD, with University of Southampton, England, said during a press briefing hosted by the UK Science Media Center where the findings were released.

The results also point to the “possible role of nonpharmacological interventions, which are currently not well established in current guidelines. However, there is a need for better evidence to fully understand the exact effect of these nonpharmacological interventions,” Cortese noted.

The study was published online in The Lancet Psychiatry. 

 

Bridging the Knowledge Gap

Once thought to be a childhood disorder only, ADHD is now well-known to persist into adulthood, affecting roughly 2.5% of the general adult population worldwide. The comparative benefits and harms of available interventions for ADHD in adults remain unclear.

To address this knowledge gap, researchers did a comprehensive systematic review and component network meta-analysis comparing a broad range of drug and nondrug treatments for adults with ADHD across several outcomes.

For reducing core ADHD symptoms at 12 weeks, only stimulants and atomoxetine were better than placebo in self-reported and clinician-reported rating scales, the study team found.

For stimulants, the standardized mean differences (SMDs) on the self-reported and clinician-reported scales were 0.39 and 0.61, respectively. The corresponding SMDs for atomoxetine were 0.38 and 0.51.

There was no evidence that ADHD medications were better than placebo in improving additional relevant outcomes such as quality of life.

In terms of nondrug interventions, cognitive behavioral therapy, cognitive remediation, mindfulness, psychoeducation, and transcranial direct current stimulation were better than placebo only on clinician-reported measures, with SMDs of −1.35, −0.79, −0.77, and −0.78, respectively.

However, the evidence for nondrug strategies is less conclusive overall, with “discordant results across types of raters and based on a small body of evidence,” the authors wrote in their article.

And evidence for long-term efficacy (beyond 12 weeks) for ADHD interventions is “limited and under-investigated,” they said.

Regarding acceptability, all strategies were similar to placebo except for atomoxetine and guanfacine which had lower acceptability than placebo.

“It’s very important to emphasize that we focused on the average effect, not at an individual level,” first author Edoardo Ostinelli, MD, with University of Oxford, England, said at the briefing. “Therefore, we cannot make any recommendation at an individual level. We need studies with individual participant data so that we can personalize treatment.”

Cortese said the information from this analysis may be particularly important for “psychoeducation” of the patient before actually starting with a treatment plan. Patients often ask about nonpharmacological interventions and this study provides the “best synthesis of available data to inform these discussions,” he said.

 

Experts Weigh In 

Several experts weighed in on the results in a statement from the UK Science Media Center.

Celso Arango, MD, PhD, psychiatrist with Gregorio Marañón General University Hospital, Madrid, Spain, noted that there is a “clear shortage of research on ADHD in adulthood, particularly regarding medium-term (beyond 12 weeks) and long-term treatment outcomes. Consequently, the findings are applicable only to short-term treatment.”

Another strength of the study is that it was developed with input from people with ADHD, Arango added, making it “highly relevant.”

The majority of studies available for the analysis involved pharmacological treatments, which is important to consider when interpreting the findings, noted Katya Rubia, PhD, professor of cognitive neuroscience, King’s College London, England.

“For example, for neurostimulation, only 10 studies were included and on very heterogeneous stimulation methods,” Rubia said. “The evidence on the efficacy of neurostimulation is therefore hardly conclusive and more studies are needed to establish their efficacy.”

Roi Cohen Kadosh, PhD, professor of cognitive neuroscience, University of Surrey, Guildford, England, agreed. While the study is a “valuable contribution to the literature,” it sheds light on “both the scarcity of neurostimulation research and the limited exploration of combined treatment approaches for ADHD,” he said.

“While novel neurostimulation methods linked to neuroplasticity — such as those we have demonstrated to be superior in children with ADHD — were not covered here, they have shown promising and lasting benefits. In contrast, research in adults remains relatively underdeveloped. Moving forward, greater emphasis on innovative, tolerable, personalized, and sustainable neurostimulation approaches is essential to meet the unmet clinical needs of adults with ADHD,” Kadosh added.

In a commentary in The Lancet Psychiatry, David Coghill, MD, with The University of Melbourne, Australia, cautioned that the findings do not mean that potential benefits of nonpharmacological interventions should be dismissed.

“While some of the nonpharmacological treatments (eg, cognitive behavioral therapy, cognitive remediation, mindfulness, psychoeducation, and transcranial direct current stimulation) showed effects on clinician-rated outcomes similar to, and in some cases greater than, the pharmacological treatments, they did not show the same effects on self-reported outcomes. These interventions were therefore considered less robust than the pharmacological treatments that showed changes on both measurement types,” he wrote.

This study had no commercial funding. Ostinelli had received research and consultancy fees from Angelini Pharma. Cortese received reimbursement for travel and accommodation expenses in relation to lectures delivered for the Association for Child and Adolescent Central Health, the Canadian ADHD Alliance Resource, and the British Association of Psychopharmacology; and had received honoraria from MEDICE; and is chair of the European ADHD Guidelines Group. Arango, Rubia, and Kadosh had no relevant disclosures. Coghill had received honoraria from CCM Conecta, Takeda, Novartis, Servier, and MEDICE.

A version of this article first appeared on Medscape.com.

Of all the currently available pharmacological and nonpharmacological therapies for attention deficit and hyperactivity disorder (ADHD) in adults, only stimulants and atomoxetine are effective at reducing core symptoms, results of a large comprehensive meta-analysis showed.

The study of 113 randomized controlled trials with nearly 15,000 adults with a formal diagnosis of ADHD also revealed that atomoxetine is less acceptable to patients and that results of efficacy of nonpharmacological strategies are inconsistent.

Data on long-term efficacy of ADHD therapies are lacking, investigators noted, so these results only apply to short-term efficacy.

“There is a lot of controversy about medication, so these are quite reassuring data and certainly reinforce the role of medication as a treatment for ADHD,” study investigator Samuele Cortese, MD, PhD, with University of Southampton, England, said during a press briefing hosted by the UK Science Media Center where the findings were released.

The results also point to the “possible role of nonpharmacological interventions, which are currently not well established in current guidelines. However, there is a need for better evidence to fully understand the exact effect of these nonpharmacological interventions,” Cortese noted.

The study was published online in The Lancet Psychiatry. 

 

Bridging the Knowledge Gap

Once thought to be a childhood disorder only, ADHD is now well-known to persist into adulthood, affecting roughly 2.5% of the general adult population worldwide. The comparative benefits and harms of available interventions for ADHD in adults remain unclear.

To address this knowledge gap, researchers did a comprehensive systematic review and component network meta-analysis comparing a broad range of drug and nondrug treatments for adults with ADHD across several outcomes.

For reducing core ADHD symptoms at 12 weeks, only stimulants and atomoxetine were better than placebo in self-reported and clinician-reported rating scales, the study team found.

For stimulants, the standardized mean differences (SMDs) on the self-reported and clinician-reported scales were 0.39 and 0.61, respectively. The corresponding SMDs for atomoxetine were 0.38 and 0.51.

There was no evidence that ADHD medications were better than placebo in improving additional relevant outcomes such as quality of life.

In terms of nondrug interventions, cognitive behavioral therapy, cognitive remediation, mindfulness, psychoeducation, and transcranial direct current stimulation were better than placebo only on clinician-reported measures, with SMDs of −1.35, −0.79, −0.77, and −0.78, respectively.

However, the evidence for nondrug strategies is less conclusive overall, with “discordant results across types of raters and based on a small body of evidence,” the authors wrote in their article.

And evidence for long-term efficacy (beyond 12 weeks) for ADHD interventions is “limited and under-investigated,” they said.

Regarding acceptability, all strategies were similar to placebo except for atomoxetine and guanfacine which had lower acceptability than placebo.

“It’s very important to emphasize that we focused on the average effect, not at an individual level,” first author Edoardo Ostinelli, MD, with University of Oxford, England, said at the briefing. “Therefore, we cannot make any recommendation at an individual level. We need studies with individual participant data so that we can personalize treatment.”

Cortese said the information from this analysis may be particularly important for “psychoeducation” of the patient before actually starting with a treatment plan. Patients often ask about nonpharmacological interventions and this study provides the “best synthesis of available data to inform these discussions,” he said.

 

Experts Weigh In 

Several experts weighed in on the results in a statement from the UK Science Media Center.

Celso Arango, MD, PhD, psychiatrist with Gregorio Marañón General University Hospital, Madrid, Spain, noted that there is a “clear shortage of research on ADHD in adulthood, particularly regarding medium-term (beyond 12 weeks) and long-term treatment outcomes. Consequently, the findings are applicable only to short-term treatment.”

Another strength of the study is that it was developed with input from people with ADHD, Arango added, making it “highly relevant.”

The majority of studies available for the analysis involved pharmacological treatments, which is important to consider when interpreting the findings, noted Katya Rubia, PhD, professor of cognitive neuroscience, King’s College London, England.

“For example, for neurostimulation, only 10 studies were included and on very heterogeneous stimulation methods,” Rubia said. “The evidence on the efficacy of neurostimulation is therefore hardly conclusive and more studies are needed to establish their efficacy.”

Roi Cohen Kadosh, PhD, professor of cognitive neuroscience, University of Surrey, Guildford, England, agreed. While the study is a “valuable contribution to the literature,” it sheds light on “both the scarcity of neurostimulation research and the limited exploration of combined treatment approaches for ADHD,” he said.

“While novel neurostimulation methods linked to neuroplasticity — such as those we have demonstrated to be superior in children with ADHD — were not covered here, they have shown promising and lasting benefits. In contrast, research in adults remains relatively underdeveloped. Moving forward, greater emphasis on innovative, tolerable, personalized, and sustainable neurostimulation approaches is essential to meet the unmet clinical needs of adults with ADHD,” Kadosh added.

In a commentary in The Lancet Psychiatry, David Coghill, MD, with The University of Melbourne, Australia, cautioned that the findings do not mean that potential benefits of nonpharmacological interventions should be dismissed.

“While some of the nonpharmacological treatments (eg, cognitive behavioral therapy, cognitive remediation, mindfulness, psychoeducation, and transcranial direct current stimulation) showed effects on clinician-rated outcomes similar to, and in some cases greater than, the pharmacological treatments, they did not show the same effects on self-reported outcomes. These interventions were therefore considered less robust than the pharmacological treatments that showed changes on both measurement types,” he wrote.

This study had no commercial funding. Ostinelli had received research and consultancy fees from Angelini Pharma. Cortese received reimbursement for travel and accommodation expenses in relation to lectures delivered for the Association for Child and Adolescent Central Health, the Canadian ADHD Alliance Resource, and the British Association of Psychopharmacology; and had received honoraria from MEDICE; and is chair of the European ADHD Guidelines Group. Arango, Rubia, and Kadosh had no relevant disclosures. Coghill had received honoraria from CCM Conecta, Takeda, Novartis, Servier, and MEDICE.

A version of this article first appeared on Medscape.com.

Of all the currently available pharmacological and nonpharmacological therapies for attention deficit and hyperactivity disorder (ADHD) in adults, only stimulants and atomoxetine are effective at reducing core symptoms, results of a large comprehensive meta-analysis showed.

The study of 113 randomized controlled trials with nearly 15,000 adults with a formal diagnosis of ADHD also revealed that atomoxetine is less acceptable to patients and that results of efficacy of nonpharmacological strategies are inconsistent.

Data on long-term efficacy of ADHD therapies are lacking, investigators noted, so these results only apply to short-term efficacy.

“There is a lot of controversy about medication, so these are quite reassuring data and certainly reinforce the role of medication as a treatment for ADHD,” study investigator Samuele Cortese, MD, PhD, with University of Southampton, England, said during a press briefing hosted by the UK Science Media Center where the findings were released.

The results also point to the “possible role of nonpharmacological interventions, which are currently not well established in current guidelines. However, there is a need for better evidence to fully understand the exact effect of these nonpharmacological interventions,” Cortese noted.

The study was published online in The Lancet Psychiatry. 

 

Bridging the Knowledge Gap

Once thought to be a childhood disorder only, ADHD is now well-known to persist into adulthood, affecting roughly 2.5% of the general adult population worldwide. The comparative benefits and harms of available interventions for ADHD in adults remain unclear.

To address this knowledge gap, researchers did a comprehensive systematic review and component network meta-analysis comparing a broad range of drug and nondrug treatments for adults with ADHD across several outcomes.

For reducing core ADHD symptoms at 12 weeks, only stimulants and atomoxetine were better than placebo in self-reported and clinician-reported rating scales, the study team found.

For stimulants, the standardized mean differences (SMDs) on the self-reported and clinician-reported scales were 0.39 and 0.61, respectively. The corresponding SMDs for atomoxetine were 0.38 and 0.51.

There was no evidence that ADHD medications were better than placebo in improving additional relevant outcomes such as quality of life.

In terms of nondrug interventions, cognitive behavioral therapy, cognitive remediation, mindfulness, psychoeducation, and transcranial direct current stimulation were better than placebo only on clinician-reported measures, with SMDs of −1.35, −0.79, −0.77, and −0.78, respectively.

However, the evidence for nondrug strategies is less conclusive overall, with “discordant results across types of raters and based on a small body of evidence,” the authors wrote in their article.

And evidence for long-term efficacy (beyond 12 weeks) for ADHD interventions is “limited and under-investigated,” they said.

Regarding acceptability, all strategies were similar to placebo except for atomoxetine and guanfacine which had lower acceptability than placebo.

“It’s very important to emphasize that we focused on the average effect, not at an individual level,” first author Edoardo Ostinelli, MD, with University of Oxford, England, said at the briefing. “Therefore, we cannot make any recommendation at an individual level. We need studies with individual participant data so that we can personalize treatment.”

Cortese said the information from this analysis may be particularly important for “psychoeducation” of the patient before actually starting with a treatment plan. Patients often ask about nonpharmacological interventions and this study provides the “best synthesis of available data to inform these discussions,” he said.

 

Experts Weigh In 

Several experts weighed in on the results in a statement from the UK Science Media Center.

Celso Arango, MD, PhD, psychiatrist with Gregorio Marañón General University Hospital, Madrid, Spain, noted that there is a “clear shortage of research on ADHD in adulthood, particularly regarding medium-term (beyond 12 weeks) and long-term treatment outcomes. Consequently, the findings are applicable only to short-term treatment.”

Another strength of the study is that it was developed with input from people with ADHD, Arango added, making it “highly relevant.”

The majority of studies available for the analysis involved pharmacological treatments, which is important to consider when interpreting the findings, noted Katya Rubia, PhD, professor of cognitive neuroscience, King’s College London, England.

“For example, for neurostimulation, only 10 studies were included and on very heterogeneous stimulation methods,” Rubia said. “The evidence on the efficacy of neurostimulation is therefore hardly conclusive and more studies are needed to establish their efficacy.”

Roi Cohen Kadosh, PhD, professor of cognitive neuroscience, University of Surrey, Guildford, England, agreed. While the study is a “valuable contribution to the literature,” it sheds light on “both the scarcity of neurostimulation research and the limited exploration of combined treatment approaches for ADHD,” he said.

“While novel neurostimulation methods linked to neuroplasticity — such as those we have demonstrated to be superior in children with ADHD — were not covered here, they have shown promising and lasting benefits. In contrast, research in adults remains relatively underdeveloped. Moving forward, greater emphasis on innovative, tolerable, personalized, and sustainable neurostimulation approaches is essential to meet the unmet clinical needs of adults with ADHD,” Kadosh added.

In a commentary in The Lancet Psychiatry, David Coghill, MD, with The University of Melbourne, Australia, cautioned that the findings do not mean that potential benefits of nonpharmacological interventions should be dismissed.

“While some of the nonpharmacological treatments (eg, cognitive behavioral therapy, cognitive remediation, mindfulness, psychoeducation, and transcranial direct current stimulation) showed effects on clinician-rated outcomes similar to, and in some cases greater than, the pharmacological treatments, they did not show the same effects on self-reported outcomes. These interventions were therefore considered less robust than the pharmacological treatments that showed changes on both measurement types,” he wrote.

This study had no commercial funding. Ostinelli had received research and consultancy fees from Angelini Pharma. Cortese received reimbursement for travel and accommodation expenses in relation to lectures delivered for the Association for Child and Adolescent Central Health, the Canadian ADHD Alliance Resource, and the British Association of Psychopharmacology; and had received honoraria from MEDICE; and is chair of the European ADHD Guidelines Group. Arango, Rubia, and Kadosh had no relevant disclosures. Coghill had received honoraria from CCM Conecta, Takeda, Novartis, Servier, and MEDICE.

A version of this article first appeared on Medscape.com.

In the latest effort to address the mental health crisis among adolescents, legislation in California would require social media platforms to come with a “black box” mental health warning label.

Despite growing evidence linking young people’s use of social media to significant health risks including depression, anxiety, and suicidal thoughts, social media companies have failed to be transparent about the risks, said Assembly member Rebecca Bauer-Kahan (D-Orinda), who introduced Assembly Bill (AB) 56.

“AB 56 ensures that families are armed with clear, actionable information to understand these dangers and make decisions that prioritizes their children’s well-being,” she said in a press release.

Bauer-Kahan noted that 95% of teens report using at least one social media platform and that more than one third say they use social media almost constantly.

“There is a powerful profit motive to keep our young people hooked online and engaged and it is exploiting the human psychology with notifications, likes, endless scrolling, and algorithmic amplification that is harming our children every day,” she said at a press conference on December 9 announcing the bill.

The warning labels are an equitable and transparent way to communicate the risks that social media poses to young users, California’s Attorney General Rob Bonta, a sponsor of AB 56, said in a press release.

Speaking at the press conference, Bonta said social media has many “incredible benefits” from giving people an outlet of expression to providing access to critical information but “there is no disputing the fact, it can have an enormously detrimental and dangerous impact on our young people. You cannot debate that. Our children are suffering.”

If AB 56 is successful, he said social media platforms would be required to display a “black box warning” for all users that would appear upon the first use of a platform and weekly thereafter.

The proposed language for the warning label is: “The Surgeon General has advised that there are ample indicators that social media can have a profound risk of harm to the mental health and well-being of children and adolescents.”

“This warning label isn’t a panacea, we know that, but it is another tool in our toolbox. It’s one prong in what has to be a multi-pronged continued, coordinated effort to address this public health crisis,” Bonta said.

Reached for comment, Bonta’s office said sponsorship of the bill was informed by their ongoing work to create a safer online space for children and teens and by the US Surgeon General’s call to Congress to add warning labels to social media.

In June, US Surgeon General Vivek Murthy, MD, said a Surgeon General’s warning label is needed to address the mental health emergency among adolescents and noted that evidence from tobacco studies shows warning labels can increase awareness and change behavior. In September, the attorneys general of 42 states announced their support of the proposal.

Also in September, US Senators John Fetterman (D-PA) and Katie Britt (R-AL) introduced the Stop the Scroll Act to create a mental health warning label requirement for social media platforms.

In a controversial move in November, Australia passed the world’s first law banning social media for children younger than 16 years. The law gives platforms such as TikTok, Facebook, X, Snapchat, and Instagram 1 year to figure out how to implement the ban before facing fines of up 50 million Australian dollars ($33 million) for systemic failures to prevent children younger than 16 years from holding accounts.

 

‘A Broken Fire Alarm’

“Slapping a warning label on social media is like a broken fire alarm going off with no evidence of smoke. It ignores the reality that most teens view social media as an important outlet for social connection,” Todd O’Boyle, with the tech industry policy group Chamber of Progress, said in a statement on AB 56.

He highlighted a 2022 Pew Research Center survey reporting that most teens credit social media with deepening connections and providing a support network and a 2020 study reporting that social media is not a strong or consistent risk factor for depressive symptoms in US adolescents.

O’Boyle predicted that, without strong evidence, AB 56 will run into the same “First Amendment buzzsaw” that has doomed other California kids’ bills.

Pediatrician Jason Nagata, MD, University of California San Francisco, points out in Bonta’s press release that social media can displace time for other healthful activities including sleep, exercise, and in-person socialization.

“While social media can provide educational content, it can also provide misinformation about health and expose children to content that damages their mental well-being. These are risks that adolescents and their parents should be aware of,” Nagata said.

Indeed, a tearful Victoria Hinks of Larkspur, California, spoke at the press conference of her 16-year-old daughter, Alexandra, who committed suicide 4 months ago after being sucked into social media and served content on self-harm, eating disorders, suicidal ideation, and glamorization of suicide.

“She was led down dark rabbit holes she had no hope of escaping,” Hinks said. “There is not a bone in my body that doubts social media played a role leading her to that final irreversible decision.”

Jim Steyer, CEO and founder of Common Sense Media, applauded California for being the first state to introduce social media warning label legislation. The group plans to lobby for similar proposals in other states he said at the press conference, noting that there are “tens of thousands of Alexandras out there.”

“We have seat belt laws, we have warning labels on cigarettes and alcohol, and that’s what we’re doing here,” Steyer said. “It’s a straightforward simple proposition, which is put your kids and teenagers first, put their self-interest first and hold the largest, most powerful, and wealthy companies in all of our lifetimes accountable for the harms that have happened on their platforms.”

A version of this article first appeared on Medscape.com.

In the latest effort to address the mental health crisis among adolescents, legislation in California would require social media platforms to come with a “black box” mental health warning label.

Despite growing evidence linking young people’s use of social media to significant health risks including depression, anxiety, and suicidal thoughts, social media companies have failed to be transparent about the risks, said Assembly member Rebecca Bauer-Kahan (D-Orinda), who introduced Assembly Bill (AB) 56.

“AB 56 ensures that families are armed with clear, actionable information to understand these dangers and make decisions that prioritizes their children’s well-being,” she said in a press release.

Bauer-Kahan noted that 95% of teens report using at least one social media platform and that more than one third say they use social media almost constantly.

“There is a powerful profit motive to keep our young people hooked online and engaged and it is exploiting the human psychology with notifications, likes, endless scrolling, and algorithmic amplification that is harming our children every day,” she said at a press conference on December 9 announcing the bill.

The warning labels are an equitable and transparent way to communicate the risks that social media poses to young users, California’s Attorney General Rob Bonta, a sponsor of AB 56, said in a press release.

Speaking at the press conference, Bonta said social media has many “incredible benefits” from giving people an outlet of expression to providing access to critical information but “there is no disputing the fact, it can have an enormously detrimental and dangerous impact on our young people. You cannot debate that. Our children are suffering.”

If AB 56 is successful, he said social media platforms would be required to display a “black box warning” for all users that would appear upon the first use of a platform and weekly thereafter.

The proposed language for the warning label is: “The Surgeon General has advised that there are ample indicators that social media can have a profound risk of harm to the mental health and well-being of children and adolescents.”

“This warning label isn’t a panacea, we know that, but it is another tool in our toolbox. It’s one prong in what has to be a multi-pronged continued, coordinated effort to address this public health crisis,” Bonta said.

Reached for comment, Bonta’s office said sponsorship of the bill was informed by their ongoing work to create a safer online space for children and teens and by the US Surgeon General’s call to Congress to add warning labels to social media.

In June, US Surgeon General Vivek Murthy, MD, said a Surgeon General’s warning label is needed to address the mental health emergency among adolescents and noted that evidence from tobacco studies shows warning labels can increase awareness and change behavior. In September, the attorneys general of 42 states announced their support of the proposal.

Also in September, US Senators John Fetterman (D-PA) and Katie Britt (R-AL) introduced the Stop the Scroll Act to create a mental health warning label requirement for social media platforms.

In a controversial move in November, Australia passed the world’s first law banning social media for children younger than 16 years. The law gives platforms such as TikTok, Facebook, X, Snapchat, and Instagram 1 year to figure out how to implement the ban before facing fines of up 50 million Australian dollars ($33 million) for systemic failures to prevent children younger than 16 years from holding accounts.

 

‘A Broken Fire Alarm’

“Slapping a warning label on social media is like a broken fire alarm going off with no evidence of smoke. It ignores the reality that most teens view social media as an important outlet for social connection,” Todd O’Boyle, with the tech industry policy group Chamber of Progress, said in a statement on AB 56.

He highlighted a 2022 Pew Research Center survey reporting that most teens credit social media with deepening connections and providing a support network and a 2020 study reporting that social media is not a strong or consistent risk factor for depressive symptoms in US adolescents.

O’Boyle predicted that, without strong evidence, AB 56 will run into the same “First Amendment buzzsaw” that has doomed other California kids’ bills.

Pediatrician Jason Nagata, MD, University of California San Francisco, points out in Bonta’s press release that social media can displace time for other healthful activities including sleep, exercise, and in-person socialization.

“While social media can provide educational content, it can also provide misinformation about health and expose children to content that damages their mental well-being. These are risks that adolescents and their parents should be aware of,” Nagata said.

Indeed, a tearful Victoria Hinks of Larkspur, California, spoke at the press conference of her 16-year-old daughter, Alexandra, who committed suicide 4 months ago after being sucked into social media and served content on self-harm, eating disorders, suicidal ideation, and glamorization of suicide.

“She was led down dark rabbit holes she had no hope of escaping,” Hinks said. “There is not a bone in my body that doubts social media played a role leading her to that final irreversible decision.”

Jim Steyer, CEO and founder of Common Sense Media, applauded California for being the first state to introduce social media warning label legislation. The group plans to lobby for similar proposals in other states he said at the press conference, noting that there are “tens of thousands of Alexandras out there.”

“We have seat belt laws, we have warning labels on cigarettes and alcohol, and that’s what we’re doing here,” Steyer said. “It’s a straightforward simple proposition, which is put your kids and teenagers first, put their self-interest first and hold the largest, most powerful, and wealthy companies in all of our lifetimes accountable for the harms that have happened on their platforms.”

A version of this article first appeared on Medscape.com.

In the latest effort to address the mental health crisis among adolescents, legislation in California would require social media platforms to come with a “black box” mental health warning label.

Despite growing evidence linking young people’s use of social media to significant health risks including depression, anxiety, and suicidal thoughts, social media companies have failed to be transparent about the risks, said Assembly member Rebecca Bauer-Kahan (D-Orinda), who introduced Assembly Bill (AB) 56.

“AB 56 ensures that families are armed with clear, actionable information to understand these dangers and make decisions that prioritizes their children’s well-being,” she said in a press release.

Bauer-Kahan noted that 95% of teens report using at least one social media platform and that more than one third say they use social media almost constantly.

“There is a powerful profit motive to keep our young people hooked online and engaged and it is exploiting the human psychology with notifications, likes, endless scrolling, and algorithmic amplification that is harming our children every day,” she said at a press conference on December 9 announcing the bill.

The warning labels are an equitable and transparent way to communicate the risks that social media poses to young users, California’s Attorney General Rob Bonta, a sponsor of AB 56, said in a press release.

Speaking at the press conference, Bonta said social media has many “incredible benefits” from giving people an outlet of expression to providing access to critical information but “there is no disputing the fact, it can have an enormously detrimental and dangerous impact on our young people. You cannot debate that. Our children are suffering.”

If AB 56 is successful, he said social media platforms would be required to display a “black box warning” for all users that would appear upon the first use of a platform and weekly thereafter.

The proposed language for the warning label is: “The Surgeon General has advised that there are ample indicators that social media can have a profound risk of harm to the mental health and well-being of children and adolescents.”

“This warning label isn’t a panacea, we know that, but it is another tool in our toolbox. It’s one prong in what has to be a multi-pronged continued, coordinated effort to address this public health crisis,” Bonta said.

Reached for comment, Bonta’s office said sponsorship of the bill was informed by their ongoing work to create a safer online space for children and teens and by the US Surgeon General’s call to Congress to add warning labels to social media.

In June, US Surgeon General Vivek Murthy, MD, said a Surgeon General’s warning label is needed to address the mental health emergency among adolescents and noted that evidence from tobacco studies shows warning labels can increase awareness and change behavior. In September, the attorneys general of 42 states announced their support of the proposal.

Also in September, US Senators John Fetterman (D-PA) and Katie Britt (R-AL) introduced the Stop the Scroll Act to create a mental health warning label requirement for social media platforms.

In a controversial move in November, Australia passed the world’s first law banning social media for children younger than 16 years. The law gives platforms such as TikTok, Facebook, X, Snapchat, and Instagram 1 year to figure out how to implement the ban before facing fines of up 50 million Australian dollars ($33 million) for systemic failures to prevent children younger than 16 years from holding accounts.

 

‘A Broken Fire Alarm’

“Slapping a warning label on social media is like a broken fire alarm going off with no evidence of smoke. It ignores the reality that most teens view social media as an important outlet for social connection,” Todd O’Boyle, with the tech industry policy group Chamber of Progress, said in a statement on AB 56.

He highlighted a 2022 Pew Research Center survey reporting that most teens credit social media with deepening connections and providing a support network and a 2020 study reporting that social media is not a strong or consistent risk factor for depressive symptoms in US adolescents.

O’Boyle predicted that, without strong evidence, AB 56 will run into the same “First Amendment buzzsaw” that has doomed other California kids’ bills.

Pediatrician Jason Nagata, MD, University of California San Francisco, points out in Bonta’s press release that social media can displace time for other healthful activities including sleep, exercise, and in-person socialization.

“While social media can provide educational content, it can also provide misinformation about health and expose children to content that damages their mental well-being. These are risks that adolescents and their parents should be aware of,” Nagata said.

Indeed, a tearful Victoria Hinks of Larkspur, California, spoke at the press conference of her 16-year-old daughter, Alexandra, who committed suicide 4 months ago after being sucked into social media and served content on self-harm, eating disorders, suicidal ideation, and glamorization of suicide.

“She was led down dark rabbit holes she had no hope of escaping,” Hinks said. “There is not a bone in my body that doubts social media played a role leading her to that final irreversible decision.”

Jim Steyer, CEO and founder of Common Sense Media, applauded California for being the first state to introduce social media warning label legislation. The group plans to lobby for similar proposals in other states he said at the press conference, noting that there are “tens of thousands of Alexandras out there.”

“We have seat belt laws, we have warning labels on cigarettes and alcohol, and that’s what we’re doing here,” Steyer said. “It’s a straightforward simple proposition, which is put your kids and teenagers first, put their self-interest first and hold the largest, most powerful, and wealthy companies in all of our lifetimes accountable for the harms that have happened on their platforms.”

A version of this article first appeared on Medscape.com.

TOPLINE:

InterRhythmic care (IRC), a novel digital intervention, was linked to greater improvements in depressive symptoms, anxiety, interpersonal relationships, and social functioning in patients with major depressive disorder (MDD), compared with internet general psychoeducation in new research.

METHODOLOGY:

• The randomized, single-blind trial included 120 outpatients from the Shanghai Mental Health Center between March and November 2021 with MDD (mean age, 28.2 years; 99% Han Chinese; 83% women) who were randomly assigned to receive either IRC or internet general psychoeducation (control group).
• IRC included computer-based psychoeducation on stabilizing social rhythm regularity and resolution of interpersonal problems plus brief online interactions with clinicians. Patients received 10 minutes of IRC daily, Monday through Friday, for 8 weeks.
• The researchers assessed participants’ depressive symptoms, anxiety symptoms, interpersonal relationships, social function, and biological rhythms using the 17-item Hamilton Depression Rating Scale, Hamilton Anxiety Scale, Interpersonal Comprehensive Diagnostic Scale, Sheehan Disability Scale, and Morning and Evening Questionnaire at baseline and at 8 weeks.

TAKEAWAY:

• The participants who received IRC had significantly lower Hamilton Depression Rating total scores than those who received internet general psychoeducation (P < .001).
• The IRC group demonstrated improved anxiety symptoms, as evidenced by lower Hamilton Anxiety Scale total scores, than those observed for the control group (P < .001).
• The IRC group also showed improved outcomes in interpersonal relationships, as indicated by lower Interpersonal Comprehensive Diagnostic Scale total scores (P < .001).
• Social functioning improved significantly in the IRC group, as measured by the Sheehan Disability Scale subscores for work/school (P = .03), social life (P < .001), and family life (P = .001).

IN PRACTICE:

“This study demonstrated that IRC can improve clinical symptoms such as depressive symptoms, anxiety symptoms, interpersonal problems, and social function in patients with MDD. Our study suggested that the IRC can be used in clinical practice,” the investigators wrote.

SOURCE:

The study was led by Chuchen Xu, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine in China. It was published online on November 20, 2024, in The Journal of Psychiatric Research.

LIMITATIONS:

The 8-week follow-up period was considered too short to comprehensively evaluate the intervention’s long-term impact. Additionally, the researchers had to check and supervise assignment completion, which increased research costs and may, therefore, potentially limit broader implementation.

DISCLOSURES:

The investigators reported no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

InterRhythmic care (IRC), a novel digital intervention, was linked to greater improvements in depressive symptoms, anxiety, interpersonal relationships, and social functioning in patients with major depressive disorder (MDD), compared with internet general psychoeducation in new research.

METHODOLOGY:

• The randomized, single-blind trial included 120 outpatients from the Shanghai Mental Health Center between March and November 2021 with MDD (mean age, 28.2 years; 99% Han Chinese; 83% women) who were randomly assigned to receive either IRC or internet general psychoeducation (control group).
• IRC included computer-based psychoeducation on stabilizing social rhythm regularity and resolution of interpersonal problems plus brief online interactions with clinicians. Patients received 10 minutes of IRC daily, Monday through Friday, for 8 weeks.
• The researchers assessed participants’ depressive symptoms, anxiety symptoms, interpersonal relationships, social function, and biological rhythms using the 17-item Hamilton Depression Rating Scale, Hamilton Anxiety Scale, Interpersonal Comprehensive Diagnostic Scale, Sheehan Disability Scale, and Morning and Evening Questionnaire at baseline and at 8 weeks.

TAKEAWAY:

• The participants who received IRC had significantly lower Hamilton Depression Rating total scores than those who received internet general psychoeducation (P < .001).
• The IRC group demonstrated improved anxiety symptoms, as evidenced by lower Hamilton Anxiety Scale total scores, than those observed for the control group (P < .001).
• The IRC group also showed improved outcomes in interpersonal relationships, as indicated by lower Interpersonal Comprehensive Diagnostic Scale total scores (P < .001).
• Social functioning improved significantly in the IRC group, as measured by the Sheehan Disability Scale subscores for work/school (P = .03), social life (P < .001), and family life (P = .001).

IN PRACTICE:

“This study demonstrated that IRC can improve clinical symptoms such as depressive symptoms, anxiety symptoms, interpersonal problems, and social function in patients with MDD. Our study suggested that the IRC can be used in clinical practice,” the investigators wrote.

SOURCE:

The study was led by Chuchen Xu, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine in China. It was published online on November 20, 2024, in The Journal of Psychiatric Research.

LIMITATIONS:

The 8-week follow-up period was considered too short to comprehensively evaluate the intervention’s long-term impact. Additionally, the researchers had to check and supervise assignment completion, which increased research costs and may, therefore, potentially limit broader implementation.

DISCLOSURES:

The investigators reported no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

InterRhythmic care (IRC), a novel digital intervention, was linked to greater improvements in depressive symptoms, anxiety, interpersonal relationships, and social functioning in patients with major depressive disorder (MDD), compared with internet general psychoeducation in new research.

METHODOLOGY:

• The randomized, single-blind trial included 120 outpatients from the Shanghai Mental Health Center between March and November 2021 with MDD (mean age, 28.2 years; 99% Han Chinese; 83% women) who were randomly assigned to receive either IRC or internet general psychoeducation (control group).
• IRC included computer-based psychoeducation on stabilizing social rhythm regularity and resolution of interpersonal problems plus brief online interactions with clinicians. Patients received 10 minutes of IRC daily, Monday through Friday, for 8 weeks.
• The researchers assessed participants’ depressive symptoms, anxiety symptoms, interpersonal relationships, social function, and biological rhythms using the 17-item Hamilton Depression Rating Scale, Hamilton Anxiety Scale, Interpersonal Comprehensive Diagnostic Scale, Sheehan Disability Scale, and Morning and Evening Questionnaire at baseline and at 8 weeks.

TAKEAWAY:

• The participants who received IRC had significantly lower Hamilton Depression Rating total scores than those who received internet general psychoeducation (P < .001).
• The IRC group demonstrated improved anxiety symptoms, as evidenced by lower Hamilton Anxiety Scale total scores, than those observed for the control group (P < .001).
• The IRC group also showed improved outcomes in interpersonal relationships, as indicated by lower Interpersonal Comprehensive Diagnostic Scale total scores (P < .001).
• Social functioning improved significantly in the IRC group, as measured by the Sheehan Disability Scale subscores for work/school (P = .03), social life (P < .001), and family life (P = .001).

IN PRACTICE:

“This study demonstrated that IRC can improve clinical symptoms such as depressive symptoms, anxiety symptoms, interpersonal problems, and social function in patients with MDD. Our study suggested that the IRC can be used in clinical practice,” the investigators wrote.

SOURCE:

The study was led by Chuchen Xu, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine in China. It was published online on November 20, 2024, in The Journal of Psychiatric Research.

LIMITATIONS:

The 8-week follow-up period was considered too short to comprehensively evaluate the intervention’s long-term impact. Additionally, the researchers had to check and supervise assignment completion, which increased research costs and may, therefore, potentially limit broader implementation.

DISCLOSURES:

The investigators reported no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

The first study funded by the US Department of Veterans Affairs (VA) for psychedelic-assisted therapy since the 1960s is currently enrolling veterans. Researchers are set to evaluate the potential of methylenedioxymethamphetamine (MDMA) for veterans with posttraumatic stress disorder (PTSD) and alcohol use disorder.   
 

The grant—about $1.5 million over 5 years—will fund a randomized, placebo-controlled trial at the Providence VA Medical Center in Rhode Island and the West Haven VA Medical Center in Connecticut by VA researchers affiliated with Brown University and Yale University. Pharmaceutical-grade MDMA will be used, and some participants will be randomly selected to receive an active placebo (lower dose of MDMA). MDMA is a psychedelic compound believed to increase emotional openness, reduce fear, and promote introspection during therapy. 
 

The study is part of the VA’s broader effort to gather definitive scientific evidence on the potential efficacy and safety of psychedelic compounds used in conjunction with psychotherapy to treat PTSD, depression, and related mental health conditions. Veterans service organizations like the American Legion and Disabled American Veterans in addition to mental health clinician groups have also called for expanded research into psychedelic compounds. The National Defense Authorization Act for fiscal year 2024 also authorized the US Department of Defense to perform research on psychedelics within military populations. 
 

In September 2023, VA and other federal clinicians, scientists, and policy makers assessed the state of scientific evidence regarding psychedelic-assisted therapies. The working groups provided advice to VA leadership, including the recommendation for the VA to begin funding its own research into these areas of care.  
 

The guidance was based on previously published studies that have found encouraging results but included few or no veteran participants. For example, a confirmatory phase 3 study by the MAPP2 Study Collaborator Group involved 104 patients, of whom only 16 were veterans.  
 

However, the findings of that study underscored the potential of the treatment: MDMA significantly improved PTSD symptoms and functional impairment, compared with placebo with therapy over 18 weeks. Notably, 45 of 52 (86%) participants treated with MDMA achieved a clinically meaningful benefit, and 37 of 52 (71%) participants no longer met criteria for PTSD by the end of the study. Consistent with an earlier study, no new major safety issues were reported. Common treatment-emergent adverse effects were like those of previous research and consistent with expected effects of MDMA. MDMA did not appear to increase the risk of suicidal ideation, and no suicidal behavior was observed. 
 

The VA researchers has conducted a limited number of small studies on psychedelics in VA facilities using non-VA funding. “VA is on the cutting edge of clinical research for veteran health, including in the investigation of psychedelics for mental health,” said Under Secretary for Health Shereef Elnahal, MD.  
 

The FDA granted breakthrough therapy status for MDMA in the treatment of PTSD and psilocybin for the treatment of depression in 2017 and 2018, respectively, based on promising preliminary research evidence. However, in June 2024 an FDA panel voted against approving a MDMA therapy for PTSD, citing concerns about research practices, a lack of diversity in the trials, and a failure to provide data on adverse effects such as potential for abuse.  
 

In August, the FDA formally rejected the treatment and called for another phase 3 study. “The FDA’s decision is disgraceful,” said Heroic Hearts Project, a veterans organization that had lobbied for FDA approval citing the many veteran suicides in a statement. “This is the epitome of bureaucratic red tape—and the result is people will keep dying.” 
 

Meanwhile, VA Press Secretary Terrence Hayes said in a statement: “VA is committed to high-quality research that safely promotes the health of our nation’s Veterans … VA anticipates that additional insights on the efficacy and safety of these therapies will add to the broader body of knowledge on MDMA-assisted psychotherapy.”

The first study funded by the US Department of Veterans Affairs (VA) for psychedelic-assisted therapy since the 1960s is currently enrolling veterans. Researchers are set to evaluate the potential of methylenedioxymethamphetamine (MDMA) for veterans with posttraumatic stress disorder (PTSD) and alcohol use disorder.   
 

The grant—about $1.5 million over 5 years—will fund a randomized, placebo-controlled trial at the Providence VA Medical Center in Rhode Island and the West Haven VA Medical Center in Connecticut by VA researchers affiliated with Brown University and Yale University. Pharmaceutical-grade MDMA will be used, and some participants will be randomly selected to receive an active placebo (lower dose of MDMA). MDMA is a psychedelic compound believed to increase emotional openness, reduce fear, and promote introspection during therapy. 
 

The study is part of the VA’s broader effort to gather definitive scientific evidence on the potential efficacy and safety of psychedelic compounds used in conjunction with psychotherapy to treat PTSD, depression, and related mental health conditions. Veterans service organizations like the American Legion and Disabled American Veterans in addition to mental health clinician groups have also called for expanded research into psychedelic compounds. The National Defense Authorization Act for fiscal year 2024 also authorized the US Department of Defense to perform research on psychedelics within military populations. 
 

In September 2023, VA and other federal clinicians, scientists, and policy makers assessed the state of scientific evidence regarding psychedelic-assisted therapies. The working groups provided advice to VA leadership, including the recommendation for the VA to begin funding its own research into these areas of care.  
 

The guidance was based on previously published studies that have found encouraging results but included few or no veteran participants. For example, a confirmatory phase 3 study by the MAPP2 Study Collaborator Group involved 104 patients, of whom only 16 were veterans.  
 

However, the findings of that study underscored the potential of the treatment: MDMA significantly improved PTSD symptoms and functional impairment, compared with placebo with therapy over 18 weeks. Notably, 45 of 52 (86%) participants treated with MDMA achieved a clinically meaningful benefit, and 37 of 52 (71%) participants no longer met criteria for PTSD by the end of the study. Consistent with an earlier study, no new major safety issues were reported. Common treatment-emergent adverse effects were like those of previous research and consistent with expected effects of MDMA. MDMA did not appear to increase the risk of suicidal ideation, and no suicidal behavior was observed. 
 

The VA researchers has conducted a limited number of small studies on psychedelics in VA facilities using non-VA funding. “VA is on the cutting edge of clinical research for veteran health, including in the investigation of psychedelics for mental health,” said Under Secretary for Health Shereef Elnahal, MD.  
 

The FDA granted breakthrough therapy status for MDMA in the treatment of PTSD and psilocybin for the treatment of depression in 2017 and 2018, respectively, based on promising preliminary research evidence. However, in June 2024 an FDA panel voted against approving a MDMA therapy for PTSD, citing concerns about research practices, a lack of diversity in the trials, and a failure to provide data on adverse effects such as potential for abuse.  
 

In August, the FDA formally rejected the treatment and called for another phase 3 study. “The FDA’s decision is disgraceful,” said Heroic Hearts Project, a veterans organization that had lobbied for FDA approval citing the many veteran suicides in a statement. “This is the epitome of bureaucratic red tape—and the result is people will keep dying.” 
 

Meanwhile, VA Press Secretary Terrence Hayes said in a statement: “VA is committed to high-quality research that safely promotes the health of our nation’s Veterans … VA anticipates that additional insights on the efficacy and safety of these therapies will add to the broader body of knowledge on MDMA-assisted psychotherapy.”

The first study funded by the US Department of Veterans Affairs (VA) for psychedelic-assisted therapy since the 1960s is currently enrolling veterans. Researchers are set to evaluate the potential of methylenedioxymethamphetamine (MDMA) for veterans with posttraumatic stress disorder (PTSD) and alcohol use disorder.   
 

The grant—about $1.5 million over 5 years—will fund a randomized, placebo-controlled trial at the Providence VA Medical Center in Rhode Island and the West Haven VA Medical Center in Connecticut by VA researchers affiliated with Brown University and Yale University. Pharmaceutical-grade MDMA will be used, and some participants will be randomly selected to receive an active placebo (lower dose of MDMA). MDMA is a psychedelic compound believed to increase emotional openness, reduce fear, and promote introspection during therapy. 
 

The study is part of the VA’s broader effort to gather definitive scientific evidence on the potential efficacy and safety of psychedelic compounds used in conjunction with psychotherapy to treat PTSD, depression, and related mental health conditions. Veterans service organizations like the American Legion and Disabled American Veterans in addition to mental health clinician groups have also called for expanded research into psychedelic compounds. The National Defense Authorization Act for fiscal year 2024 also authorized the US Department of Defense to perform research on psychedelics within military populations. 
 

In September 2023, VA and other federal clinicians, scientists, and policy makers assessed the state of scientific evidence regarding psychedelic-assisted therapies. The working groups provided advice to VA leadership, including the recommendation for the VA to begin funding its own research into these areas of care.  
 

The guidance was based on previously published studies that have found encouraging results but included few or no veteran participants. For example, a confirmatory phase 3 study by the MAPP2 Study Collaborator Group involved 104 patients, of whom only 16 were veterans.  
 

However, the findings of that study underscored the potential of the treatment: MDMA significantly improved PTSD symptoms and functional impairment, compared with placebo with therapy over 18 weeks. Notably, 45 of 52 (86%) participants treated with MDMA achieved a clinically meaningful benefit, and 37 of 52 (71%) participants no longer met criteria for PTSD by the end of the study. Consistent with an earlier study, no new major safety issues were reported. Common treatment-emergent adverse effects were like those of previous research and consistent with expected effects of MDMA. MDMA did not appear to increase the risk of suicidal ideation, and no suicidal behavior was observed. 
 

The VA researchers has conducted a limited number of small studies on psychedelics in VA facilities using non-VA funding. “VA is on the cutting edge of clinical research for veteran health, including in the investigation of psychedelics for mental health,” said Under Secretary for Health Shereef Elnahal, MD.  
 

The FDA granted breakthrough therapy status for MDMA in the treatment of PTSD and psilocybin for the treatment of depression in 2017 and 2018, respectively, based on promising preliminary research evidence. However, in June 2024 an FDA panel voted against approving a MDMA therapy for PTSD, citing concerns about research practices, a lack of diversity in the trials, and a failure to provide data on adverse effects such as potential for abuse.  
 

In August, the FDA formally rejected the treatment and called for another phase 3 study. “The FDA’s decision is disgraceful,” said Heroic Hearts Project, a veterans organization that had lobbied for FDA approval citing the many veteran suicides in a statement. “This is the epitome of bureaucratic red tape—and the result is people will keep dying.” 
 

Meanwhile, VA Press Secretary Terrence Hayes said in a statement: “VA is committed to high-quality research that safely promotes the health of our nation’s Veterans … VA anticipates that additional insights on the efficacy and safety of these therapies will add to the broader body of knowledge on MDMA-assisted psychotherapy.”

Earlier in 2024, Utah became the seventh state to allow psychologists with the proper training to prescribe psychotropic medications, giving supporters reason to hope that more states might support expanding this scope of practice.

However, the American Psychiatric Association — and some psychologists — oppose granting psychologists this privilege, arguing that the training offered is insufficient and could jeopardize patient safety.

The controversy over whether psychologists should be allowed to prescribe is as old as the so-called RxP movement itself, which began in the early 1990s.

Psychologists have not rushed to become licensed prescribers. After three decades, an estimated 226 psychologists — representing just 0.14% of all those licensed in the United States — have been authorized to prescribe in the six states and one territory where it has been legalized, according to a just-published study in Clinical Psychology.

These are Colorado, Idaho, Illinois, Iowa, Louisiana, New Mexico, and Guam. Data from the study show that only 73 psychologists are prescribing in New Mexico, which authorized it in 2002.

Less is known about the number of psychologists who are prescribing under allowances in the Department of Defense, Indian Health Service and US Public Health Service.

Some psychologists — and the American Psychological Association (APA) — believe that the persistence of the opioid epidemic coupled with a continued lack of access to mental health care for millions of Americans will bring more legislators on-side.

“I feel like we’re on an upswing again,” Deborah Baker, director of legal and regulatory policy for the APA, told Medscape Medical News. “The access issue continues to be a perennial kind of driver.” She noted that at least six states pursued expanding privileges this year.

Robert L. Trestman, MD, chair of the American Psychiatric Association’s Council on Healthcare Systems and Financing, said he doesn’t see new momentum. The interest in having psychologists prescribe “continues to trickle based on just the frustration that people have about not getting adequate access to psychiatry,” he told Medscape Medical News.

While states may be trying to increase access to care, granting psychologists privileges is “not a very effective way of doing it,” said Trestman, Chair of Psychiatry and Behavioral Medicine at Virginia Tech Carilion School of Medicine in Roanoke. Psychologists are needed to deliver psychotherapy, he said. “It makes almost no sense to try to make them into pseudo medical professionals,” said Trestman. “It just exposes people to risks.”

William Robiner, PhD — author of Clinical Psychology study — is a long-time opponent of RxP. The psychologist told Medscape Medical News he’s concerned about patient safety and “about some of the disingenuous reasons” that psychologists want to prescribe. Among these are the ability to increase status and income, said Robiner, a professor of medicine at the University of Minnesota Medical School, Minneapolis, and a board member of Psychologists Opposed to Prescription Privileges for Psychologists.

 

Adequate Training?

Only PhD and PsyD psychologists are eligible for RxP training, which entails a master’s in clinical psychopharmacology. After receiving the master’s, they must pass the Psychopharmacology Examination for Psychologists and then are only permitted to prescribe medications for mental health disorders.

They must also obtain a Drug Enforcement Administration license but can’t write prescriptions for schedule 2 medications. In some states, psychologists can prescribe buprenorphine and other opioid use disorder medications.

The APA has developed guidance for master’s programs, which currently number just over a handful in the United States.

At Fairleigh Dickinson University in New Jersey, students enrolled in the master’s program — a distance-learning format — complete 10 courses over five 15-week semesters. The curriculum spans a range of topics, from foundational sciences and legal and ethical considerations to strategies for treating specific disorders.

Derek Phillips, PhD, the program’s executive director, said that when he took the position in 2020, enrollment was capped at 45 students, but “we were not routinely enrolling the maximum.” Now, even with class size increased to 60 “we are consistently full and have a waitlist,” he told Medscape Medical News.

Interest is being driven in part by new laws in Colorado (2023) and Utah, said Phillips. But many are enrolling without intending to write a prescription, he said. The degree gives graduates the ability to better collaborate with other clinicians, teach clinical psychopharmacology, and be expert witnesses in medico-legal cases, he said.

In addition, the training gives students “a balanced and thorough biopsychosocial understanding of our patients,” he said. Students also see the “potential of being able to be a ‘one-stop-stop’ of mental health services,” said Phillips.

The American Board of Professional Psychology is developing a board certification in clinical psychopharmacology.

The APA states on its website that prescribing psychologists have “more training in diagnosing and treating (including prescribing) mental health disorders than primary care physicians.”

However, critics argue that the training falls short. Most psychologists, said Robiner, have not completed the undergraduate prerequisites — such as anatomy, physiology, and chemistry — that are required for other prescribing professionals.

In a 2019 article comparing the training of prescribing professionals, Robiner and colleagues reported that psychiatrists undergo 4- to 6-week rotations during medical school and accumulate 8000 clinical hours focused on psychiatric conditions over the course of their 4-year residencies.

States set requirements for clinical hours for prescribing psychologists, but they are generally elective and completed after individuals receive a master’s degree.

Robiner said psychologists aren’t trained in evaluating drug-related adverse events. “If you show a psychologist a rash, they have no idea whether that rash might be a medication adverse effect or poison ivy,” he said.

Trestman pointed out that many psychotropic medications have black box warnings. “The risk of toxicity is by no means trivial, and the majority of people who are seeking care in psychiatry have multiple comorbidities,” he said. “Giving people the equivalent of more or less 10 weeks of training is just woefully inappropriate,” Trestman said.

 

Increase in Access?

Psychology’s main argument for expanding its scope of practice is that it will increase the number of clinicians available to provide behavioral and mental health care.

Critics said that is a failed experiment, in part because so few psychologists have become prescribers, but also because most psychologists practice in the same areas as psychiatrists. Both specialists tend to cluster in urban regions, which already have high clinician density, said Trestman.

Psychologists are not practicing in underserved rural areas, as even APA data show. A 2018 APA snapshot of the workforce found that the highest density of psychologists was in Washington, DC, Massachusetts, and New York. South Carolina, West Virginia and Mississippi had the fewest number of psychologists per 100,000 people.

The University of Washington Rural Health Research Center reported in 2022 that in 2021, almost half of rural counties did not have a psychologist compared with 15.7% of urban counties.

Psychiatrists also are concentrated on the coasts and New England, according to a study by Ohio State researchers. The highest densities were in Washington, DC (79 per 100,000), Massachusetts (45.3), Rhode Island (42.6), Connecticut (38.6) and Vermont (37.7), whereas the lowest densities were in Idaho (11.8), Mississippi (11.8), Wyoming (12.4), Alabama (13.1), and Indiana (13.5). The study estimated that there were 57,163 psychiatrists responsible for the care of 333,287,557 Americans. “Clinical psychologists, psychotherapists, and counselors can provide alternative forms of intervention, though access to such services is also poor in rural areas,” wrote the authors.

The APA counters with data it says shows that RxP may have increased access. Using the number of psychology practices as a proxy for supply, the authors reported that practices grew in New Mexico, Illinois, Iowa, and Idaho — states that have implemented prescription privileges. Overall, there was an increase of 0.8047 practices per 100,000 residents per county.

However, the access argument “is seriously challenged by the reality of the limited number of psychologists who complete the pathway to prescribing,” Robiner and his colleague Tanya Tompkins countered in Clinical Psychology. They note that in Idaho — a state with shortages of psychologists and psychiatrists — just 10 of the state’s 615 psychologists had prescriptive authority. An estimated 5131 nonpsychologists are prescribers.

Robiner and Tompkins noted that it’s not clear why so few psychologists are pursuing RxP but that many seem to be unaware of the possibility.

 

Do Benefits Outweigh the Harms? 

There is not a large body of literature assessing the harms or benefits of prescribing privileges for psychologists.

Baker shared several studies by Phillip Hughes, PhD, an outcomes researcher at the University of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina. In one study, Hughes found that patients of prescribing psychologists had a 24% lower rate of adverse drug events than patients of psychiatrists. Psychologists’ patients had lower rates of psychotropic polypharmacy but similar rates of emergency room use.

In another paper Hughes suggested that deaths attributable to mental illness had declined in New Mexico after it passed its law. There was no change in Louisiana.

With little evidence of harm — and ongoing provider shortages — making use of nonphysician prescribers is gaining traction with policymakers, claims the psychology association’s Baker, adding that in Utah, the Republican governor was the biggest supporter.

But psychiatrists argue that it’s more important to increase their numbers. Congress agreed in 2021 and 2023 to add 1200 new residency slots — in every specialty — to ease physician shortages. The Centers for Medicare & Medicaid Services recently announced that 70% of the new slots for July 2025 will go to primary care and psychiatry.

“Once those positions are in place, it will be four more years before the first crop of new psychiatrists come out,” noted Trestman. “None of these fixes are quick,” he said.

Baker, Robiner, and Trestman reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Earlier in 2024, Utah became the seventh state to allow psychologists with the proper training to prescribe psychotropic medications, giving supporters reason to hope that more states might support expanding this scope of practice.

However, the American Psychiatric Association — and some psychologists — oppose granting psychologists this privilege, arguing that the training offered is insufficient and could jeopardize patient safety.

The controversy over whether psychologists should be allowed to prescribe is as old as the so-called RxP movement itself, which began in the early 1990s.

Psychologists have not rushed to become licensed prescribers. After three decades, an estimated 226 psychologists — representing just 0.14% of all those licensed in the United States — have been authorized to prescribe in the six states and one territory where it has been legalized, according to a just-published study in Clinical Psychology.

These are Colorado, Idaho, Illinois, Iowa, Louisiana, New Mexico, and Guam. Data from the study show that only 73 psychologists are prescribing in New Mexico, which authorized it in 2002.

Less is known about the number of psychologists who are prescribing under allowances in the Department of Defense, Indian Health Service and US Public Health Service.

Some psychologists — and the American Psychological Association (APA) — believe that the persistence of the opioid epidemic coupled with a continued lack of access to mental health care for millions of Americans will bring more legislators on-side.

“I feel like we’re on an upswing again,” Deborah Baker, director of legal and regulatory policy for the APA, told Medscape Medical News. “The access issue continues to be a perennial kind of driver.” She noted that at least six states pursued expanding privileges this year.

Robert L. Trestman, MD, chair of the American Psychiatric Association’s Council on Healthcare Systems and Financing, said he doesn’t see new momentum. The interest in having psychologists prescribe “continues to trickle based on just the frustration that people have about not getting adequate access to psychiatry,” he told Medscape Medical News.

While states may be trying to increase access to care, granting psychologists privileges is “not a very effective way of doing it,” said Trestman, Chair of Psychiatry and Behavioral Medicine at Virginia Tech Carilion School of Medicine in Roanoke. Psychologists are needed to deliver psychotherapy, he said. “It makes almost no sense to try to make them into pseudo medical professionals,” said Trestman. “It just exposes people to risks.”

William Robiner, PhD — author of Clinical Psychology study — is a long-time opponent of RxP. The psychologist told Medscape Medical News he’s concerned about patient safety and “about some of the disingenuous reasons” that psychologists want to prescribe. Among these are the ability to increase status and income, said Robiner, a professor of medicine at the University of Minnesota Medical School, Minneapolis, and a board member of Psychologists Opposed to Prescription Privileges for Psychologists.

 

Adequate Training?

Only PhD and PsyD psychologists are eligible for RxP training, which entails a master’s in clinical psychopharmacology. After receiving the master’s, they must pass the Psychopharmacology Examination for Psychologists and then are only permitted to prescribe medications for mental health disorders.

They must also obtain a Drug Enforcement Administration license but can’t write prescriptions for schedule 2 medications. In some states, psychologists can prescribe buprenorphine and other opioid use disorder medications.

The APA has developed guidance for master’s programs, which currently number just over a handful in the United States.

At Fairleigh Dickinson University in New Jersey, students enrolled in the master’s program — a distance-learning format — complete 10 courses over five 15-week semesters. The curriculum spans a range of topics, from foundational sciences and legal and ethical considerations to strategies for treating specific disorders.

Derek Phillips, PhD, the program’s executive director, said that when he took the position in 2020, enrollment was capped at 45 students, but “we were not routinely enrolling the maximum.” Now, even with class size increased to 60 “we are consistently full and have a waitlist,” he told Medscape Medical News.

Interest is being driven in part by new laws in Colorado (2023) and Utah, said Phillips. But many are enrolling without intending to write a prescription, he said. The degree gives graduates the ability to better collaborate with other clinicians, teach clinical psychopharmacology, and be expert witnesses in medico-legal cases, he said.

In addition, the training gives students “a balanced and thorough biopsychosocial understanding of our patients,” he said. Students also see the “potential of being able to be a ‘one-stop-stop’ of mental health services,” said Phillips.

The American Board of Professional Psychology is developing a board certification in clinical psychopharmacology.

The APA states on its website that prescribing psychologists have “more training in diagnosing and treating (including prescribing) mental health disorders than primary care physicians.”

However, critics argue that the training falls short. Most psychologists, said Robiner, have not completed the undergraduate prerequisites — such as anatomy, physiology, and chemistry — that are required for other prescribing professionals.

In a 2019 article comparing the training of prescribing professionals, Robiner and colleagues reported that psychiatrists undergo 4- to 6-week rotations during medical school and accumulate 8000 clinical hours focused on psychiatric conditions over the course of their 4-year residencies.

States set requirements for clinical hours for prescribing psychologists, but they are generally elective and completed after individuals receive a master’s degree.

Robiner said psychologists aren’t trained in evaluating drug-related adverse events. “If you show a psychologist a rash, they have no idea whether that rash might be a medication adverse effect or poison ivy,” he said.

Trestman pointed out that many psychotropic medications have black box warnings. “The risk of toxicity is by no means trivial, and the majority of people who are seeking care in psychiatry have multiple comorbidities,” he said. “Giving people the equivalent of more or less 10 weeks of training is just woefully inappropriate,” Trestman said.

 

Increase in Access?

Psychology’s main argument for expanding its scope of practice is that it will increase the number of clinicians available to provide behavioral and mental health care.

Critics said that is a failed experiment, in part because so few psychologists have become prescribers, but also because most psychologists practice in the same areas as psychiatrists. Both specialists tend to cluster in urban regions, which already have high clinician density, said Trestman.

Psychologists are not practicing in underserved rural areas, as even APA data show. A 2018 APA snapshot of the workforce found that the highest density of psychologists was in Washington, DC, Massachusetts, and New York. South Carolina, West Virginia and Mississippi had the fewest number of psychologists per 100,000 people.

The University of Washington Rural Health Research Center reported in 2022 that in 2021, almost half of rural counties did not have a psychologist compared with 15.7% of urban counties.

Psychiatrists also are concentrated on the coasts and New England, according to a study by Ohio State researchers. The highest densities were in Washington, DC (79 per 100,000), Massachusetts (45.3), Rhode Island (42.6), Connecticut (38.6) and Vermont (37.7), whereas the lowest densities were in Idaho (11.8), Mississippi (11.8), Wyoming (12.4), Alabama (13.1), and Indiana (13.5). The study estimated that there were 57,163 psychiatrists responsible for the care of 333,287,557 Americans. “Clinical psychologists, psychotherapists, and counselors can provide alternative forms of intervention, though access to such services is also poor in rural areas,” wrote the authors.

The APA counters with data it says shows that RxP may have increased access. Using the number of psychology practices as a proxy for supply, the authors reported that practices grew in New Mexico, Illinois, Iowa, and Idaho — states that have implemented prescription privileges. Overall, there was an increase of 0.8047 practices per 100,000 residents per county.

However, the access argument “is seriously challenged by the reality of the limited number of psychologists who complete the pathway to prescribing,” Robiner and his colleague Tanya Tompkins countered in Clinical Psychology. They note that in Idaho — a state with shortages of psychologists and psychiatrists — just 10 of the state’s 615 psychologists had prescriptive authority. An estimated 5131 nonpsychologists are prescribers.

Robiner and Tompkins noted that it’s not clear why so few psychologists are pursuing RxP but that many seem to be unaware of the possibility.

 

Do Benefits Outweigh the Harms? 

There is not a large body of literature assessing the harms or benefits of prescribing privileges for psychologists.

Baker shared several studies by Phillip Hughes, PhD, an outcomes researcher at the University of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina. In one study, Hughes found that patients of prescribing psychologists had a 24% lower rate of adverse drug events than patients of psychiatrists. Psychologists’ patients had lower rates of psychotropic polypharmacy but similar rates of emergency room use.

In another paper Hughes suggested that deaths attributable to mental illness had declined in New Mexico after it passed its law. There was no change in Louisiana.

With little evidence of harm — and ongoing provider shortages — making use of nonphysician prescribers is gaining traction with policymakers, claims the psychology association’s Baker, adding that in Utah, the Republican governor was the biggest supporter.

But psychiatrists argue that it’s more important to increase their numbers. Congress agreed in 2021 and 2023 to add 1200 new residency slots — in every specialty — to ease physician shortages. The Centers for Medicare & Medicaid Services recently announced that 70% of the new slots for July 2025 will go to primary care and psychiatry.

“Once those positions are in place, it will be four more years before the first crop of new psychiatrists come out,” noted Trestman. “None of these fixes are quick,” he said.

Baker, Robiner, and Trestman reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Earlier in 2024, Utah became the seventh state to allow psychologists with the proper training to prescribe psychotropic medications, giving supporters reason to hope that more states might support expanding this scope of practice.

However, the American Psychiatric Association — and some psychologists — oppose granting psychologists this privilege, arguing that the training offered is insufficient and could jeopardize patient safety.

The controversy over whether psychologists should be allowed to prescribe is as old as the so-called RxP movement itself, which began in the early 1990s.

Psychologists have not rushed to become licensed prescribers. After three decades, an estimated 226 psychologists — representing just 0.14% of all those licensed in the United States — have been authorized to prescribe in the six states and one territory where it has been legalized, according to a just-published study in Clinical Psychology.

These are Colorado, Idaho, Illinois, Iowa, Louisiana, New Mexico, and Guam. Data from the study show that only 73 psychologists are prescribing in New Mexico, which authorized it in 2002.

Less is known about the number of psychologists who are prescribing under allowances in the Department of Defense, Indian Health Service and US Public Health Service.

Some psychologists — and the American Psychological Association (APA) — believe that the persistence of the opioid epidemic coupled with a continued lack of access to mental health care for millions of Americans will bring more legislators on-side.

“I feel like we’re on an upswing again,” Deborah Baker, director of legal and regulatory policy for the APA, told Medscape Medical News. “The access issue continues to be a perennial kind of driver.” She noted that at least six states pursued expanding privileges this year.

Robert L. Trestman, MD, chair of the American Psychiatric Association’s Council on Healthcare Systems and Financing, said he doesn’t see new momentum. The interest in having psychologists prescribe “continues to trickle based on just the frustration that people have about not getting adequate access to psychiatry,” he told Medscape Medical News.

While states may be trying to increase access to care, granting psychologists privileges is “not a very effective way of doing it,” said Trestman, Chair of Psychiatry and Behavioral Medicine at Virginia Tech Carilion School of Medicine in Roanoke. Psychologists are needed to deliver psychotherapy, he said. “It makes almost no sense to try to make them into pseudo medical professionals,” said Trestman. “It just exposes people to risks.”

William Robiner, PhD — author of Clinical Psychology study — is a long-time opponent of RxP. The psychologist told Medscape Medical News he’s concerned about patient safety and “about some of the disingenuous reasons” that psychologists want to prescribe. Among these are the ability to increase status and income, said Robiner, a professor of medicine at the University of Minnesota Medical School, Minneapolis, and a board member of Psychologists Opposed to Prescription Privileges for Psychologists.

 

Adequate Training?

Only PhD and PsyD psychologists are eligible for RxP training, which entails a master’s in clinical psychopharmacology. After receiving the master’s, they must pass the Psychopharmacology Examination for Psychologists and then are only permitted to prescribe medications for mental health disorders.

They must also obtain a Drug Enforcement Administration license but can’t write prescriptions for schedule 2 medications. In some states, psychologists can prescribe buprenorphine and other opioid use disorder medications.

The APA has developed guidance for master’s programs, which currently number just over a handful in the United States.

At Fairleigh Dickinson University in New Jersey, students enrolled in the master’s program — a distance-learning format — complete 10 courses over five 15-week semesters. The curriculum spans a range of topics, from foundational sciences and legal and ethical considerations to strategies for treating specific disorders.

Derek Phillips, PhD, the program’s executive director, said that when he took the position in 2020, enrollment was capped at 45 students, but “we were not routinely enrolling the maximum.” Now, even with class size increased to 60 “we are consistently full and have a waitlist,” he told Medscape Medical News.

Interest is being driven in part by new laws in Colorado (2023) and Utah, said Phillips. But many are enrolling without intending to write a prescription, he said. The degree gives graduates the ability to better collaborate with other clinicians, teach clinical psychopharmacology, and be expert witnesses in medico-legal cases, he said.

In addition, the training gives students “a balanced and thorough biopsychosocial understanding of our patients,” he said. Students also see the “potential of being able to be a ‘one-stop-stop’ of mental health services,” said Phillips.

The American Board of Professional Psychology is developing a board certification in clinical psychopharmacology.

The APA states on its website that prescribing psychologists have “more training in diagnosing and treating (including prescribing) mental health disorders than primary care physicians.”

However, critics argue that the training falls short. Most psychologists, said Robiner, have not completed the undergraduate prerequisites — such as anatomy, physiology, and chemistry — that are required for other prescribing professionals.

In a 2019 article comparing the training of prescribing professionals, Robiner and colleagues reported that psychiatrists undergo 4- to 6-week rotations during medical school and accumulate 8000 clinical hours focused on psychiatric conditions over the course of their 4-year residencies.

States set requirements for clinical hours for prescribing psychologists, but they are generally elective and completed after individuals receive a master’s degree.

Robiner said psychologists aren’t trained in evaluating drug-related adverse events. “If you show a psychologist a rash, they have no idea whether that rash might be a medication adverse effect or poison ivy,” he said.

Trestman pointed out that many psychotropic medications have black box warnings. “The risk of toxicity is by no means trivial, and the majority of people who are seeking care in psychiatry have multiple comorbidities,” he said. “Giving people the equivalent of more or less 10 weeks of training is just woefully inappropriate,” Trestman said.

 

Increase in Access?

Psychology’s main argument for expanding its scope of practice is that it will increase the number of clinicians available to provide behavioral and mental health care.

Critics said that is a failed experiment, in part because so few psychologists have become prescribers, but also because most psychologists practice in the same areas as psychiatrists. Both specialists tend to cluster in urban regions, which already have high clinician density, said Trestman.

Psychologists are not practicing in underserved rural areas, as even APA data show. A 2018 APA snapshot of the workforce found that the highest density of psychologists was in Washington, DC, Massachusetts, and New York. South Carolina, West Virginia and Mississippi had the fewest number of psychologists per 100,000 people.

The University of Washington Rural Health Research Center reported in 2022 that in 2021, almost half of rural counties did not have a psychologist compared with 15.7% of urban counties.

Psychiatrists also are concentrated on the coasts and New England, according to a study by Ohio State researchers. The highest densities were in Washington, DC (79 per 100,000), Massachusetts (45.3), Rhode Island (42.6), Connecticut (38.6) and Vermont (37.7), whereas the lowest densities were in Idaho (11.8), Mississippi (11.8), Wyoming (12.4), Alabama (13.1), and Indiana (13.5). The study estimated that there were 57,163 psychiatrists responsible for the care of 333,287,557 Americans. “Clinical psychologists, psychotherapists, and counselors can provide alternative forms of intervention, though access to such services is also poor in rural areas,” wrote the authors.

The APA counters with data it says shows that RxP may have increased access. Using the number of psychology practices as a proxy for supply, the authors reported that practices grew in New Mexico, Illinois, Iowa, and Idaho — states that have implemented prescription privileges. Overall, there was an increase of 0.8047 practices per 100,000 residents per county.

However, the access argument “is seriously challenged by the reality of the limited number of psychologists who complete the pathway to prescribing,” Robiner and his colleague Tanya Tompkins countered in Clinical Psychology. They note that in Idaho — a state with shortages of psychologists and psychiatrists — just 10 of the state’s 615 psychologists had prescriptive authority. An estimated 5131 nonpsychologists are prescribers.

Robiner and Tompkins noted that it’s not clear why so few psychologists are pursuing RxP but that many seem to be unaware of the possibility.

 

Do Benefits Outweigh the Harms? 

There is not a large body of literature assessing the harms or benefits of prescribing privileges for psychologists.

Baker shared several studies by Phillip Hughes, PhD, an outcomes researcher at the University of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina. In one study, Hughes found that patients of prescribing psychologists had a 24% lower rate of adverse drug events than patients of psychiatrists. Psychologists’ patients had lower rates of psychotropic polypharmacy but similar rates of emergency room use.

In another paper Hughes suggested that deaths attributable to mental illness had declined in New Mexico after it passed its law. There was no change in Louisiana.

With little evidence of harm — and ongoing provider shortages — making use of nonphysician prescribers is gaining traction with policymakers, claims the psychology association’s Baker, adding that in Utah, the Republican governor was the biggest supporter.

But psychiatrists argue that it’s more important to increase their numbers. Congress agreed in 2021 and 2023 to add 1200 new residency slots — in every specialty — to ease physician shortages. The Centers for Medicare & Medicaid Services recently announced that 70% of the new slots for July 2025 will go to primary care and psychiatry.

“Once those positions are in place, it will be four more years before the first crop of new psychiatrists come out,” noted Trestman. “None of these fixes are quick,” he said.

Baker, Robiner, and Trestman reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Childhood exposure to leaded gasoline via car exhaust over the past 75 years is linked to 151 million excess cases of psychiatric disorders in the United States, new research suggested.

The data revealed that the group most heavily exposed to lead — individuals born between 1966 and 1986, commonly known as Generation X — experienced the biggest increases in mental health issues.

Within this cohort, those born between 1966 and 1970 were affected the most. This timeline, the investigators noted, aligns with the peak use of leaded gasoline during the mid-1960s and 1970s. Specifically for this group, overall mental health issues increase by 0.35 times the average, anxiety and depression by 1.75 times, and attention-deficit/hyperactivity disorder (ADHD) symptoms by 1.17 times.

“Lead exposure across the country has probably played a significant role in worsening mental health in ways that had previously been unappreciated and invisible,” study investigator Aaron Reuben, PhD, assistant professor of clinical neuropsychology at the University of Virginia, Charlottesville, said in an interview.

However, the investigators emphasized that the study only establishes an association and not a causal relationship between leaded gas exposure and subsequent psychopathology.

The findings were published online on December 4 in The Journal of Child Psychology and Psychiatry.

 

Lead Astray?

Leaded gasoline was first used in the 1920s to stop engine knocking and improve performance. Despite early evidence of neurotoxicity its use continued until 1996 when it was banned.

The investigators noted that over half of the current US population was exposed to adverse lead levels from gasoline in childhood. However, they added the total contribution of childhood lead exposure to the population’s mental health and personality has not previously been evaluated.

For the study, the researchers combined serial, cross-sectional data on blood lead levels (BLLs) from the National Health and Nutrition Examination Survey and integrated it with historical data on gasoline usage, allowing them to estimate childhood BLLs in the United States from 1940 to 2015.

They calculated the impact of lead exposure on mental health using general psychopathology factor points, also referred to as mental illness points, which function similarly to IQ points.

These measures used were based on a prior study led by Reuben in 2019 from a New Zealand cohort and a study by a different group that followed a longitudinal birth cohort in Chicago .

Using these data, the researchers calculated population-level elevations in mental health symptoms on the basis of lead exposure and five key psychiatric outcomes in the US population.

These included general psychopathology, which reflects an individual’s overall liability to mental disorders and was scaled to match IQ scores with a mean of 100 and an SD of 15.

They also evaluated symptoms of internalizing disorders including anxiety and depression and ADHD and standardized them to a mean of 0 and an SD of 1.

The researchers also looked at differences in the personality traits of neuroticism, which relate to emotional instability and conscientiousness and reflect organization and responsibility. Both of these were assessed using similar standardized scales.

 

151 Million Excess Cases of Mental Illness

Using this approach, the researchers were able to assess the historical and long-term implications of lead exposure on mental health and personality traits in the US population over time.

Results showed that during the peak era of leaded gasoline in the United States, children were routinely exposed to lead levels three to six times higher than the current reference point for clinical concern (3.5 μg/dL of blood), the authors noted.

While the United States banned leaded gasoline in 1996, lead can still be present in water pipes, old paint, and soil. The Centers for Disease Control and Prevention cautions that no BLLs are safe.

The investigators found that between 1940 and 2015, the US population gained 602 million general psychopathology points, which the investigators said equates to 151 million excess instances of mental disorders that are primarily, but not completely, attributable to early life exposure to leaded gasoline.

“Assuming that published lead-psychopathology associations are causal and not purely correlational, we estimate that by 2015, the US population had gained 602 million General Psychopathology factor points because of exposure arising from leaded gasoline, reflecting a 0.13 standard deviation increase in overall liability to mental illness in the population and an estimated 151 million excess mental disorders attributable to lead exposure,” the researchers wrote.

Specific effects included a 0.64 SD increase in anxiety and depression symptoms, a 0.42 SD increase in ADHD symptoms, a 0.14 SD increase in ADHD symptoms, a 0.14 SD increase in emotional instability (neuroticism), and a 0.20 SD decrease in traits like organization and responsibility (conscientiousness).

These mental health and personality changes were not distributed evenly among the generations, most significant in those born between 1966 and 1986, the investigators reported.

For example, children between 1966 and 1970, the period when leaded gasoline use was at its peak, had BLLs > 5 μg/dL and experienced a 1.75 SD increase in internalizing symptoms and a 1.17 SD increase in ADHD symptoms.

 

Assess Lead Risk

The study had several limitations. Causality could not be established, and the accuracy of the estimates relied on findings from the researchers’ two previous key studies.

However, the investigators noted that these findings have been replicated across multiple cohorts and settings. Additionally, the results may not be fully generalizable to the entire US population, as one study was based in New Zealand and the other in urban Chicago.

Reuben cautioned that even though gasoline and new paint no longer contain lead, exposure is still possible.

“We saw this most acutely in Flint, Michigan,” when aging water pipes exposed more than 100,000 residents to high lead levels in 2014. “This situation made us aware that thousands of communities are exposed to lead service lines.”

He recommended that physicians consider screening patients for lead exposure — both new and old. Experts estimate that 90% of lead in the body is stored in the skeleton and can be released back into the bloodstream over time, particularly in cases of calcium deficiency, pregnancy, or osteoporosis.

While reversing childhood lead exposure is not possible, Reuben noted that healthy lifestyle choices and multimodal interventions such as medication and therapy can effectively address and alleviate mental illness.

 

‘Legacy of Lead’

In a comment, Terrie Moffitt, PhD, who was not involved in the research, said the study “is important because it gives us a crystal ball to see into the future of children living with lead today.”

“It’s called the ‘legacy of lead,’ and what a legacy,” said Moffitt, professor in the Department of Psychology and Neuroscience, Nannerl O. Keohane University at Duke University in Durham, North Carolina.

Moffitt emphasized that children exposed to lead today often live in areas of poverty and disadvantage, making it difficult to disentangle the potential effects of lead exposure from those of childhood adversity that predispose individuals to mental illness.

“This study tells us about lead’s damage in an era when it was everywhere, not just in poor communities,” she said.

The study was funded by a fellowship from the National Institute of Environmental Health Sciences. Reuben and Moffitt reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Childhood exposure to leaded gasoline via car exhaust over the past 75 years is linked to 151 million excess cases of psychiatric disorders in the United States, new research suggested.

The data revealed that the group most heavily exposed to lead — individuals born between 1966 and 1986, commonly known as Generation X — experienced the biggest increases in mental health issues.

Within this cohort, those born between 1966 and 1970 were affected the most. This timeline, the investigators noted, aligns with the peak use of leaded gasoline during the mid-1960s and 1970s. Specifically for this group, overall mental health issues increase by 0.35 times the average, anxiety and depression by 1.75 times, and attention-deficit/hyperactivity disorder (ADHD) symptoms by 1.17 times.

“Lead exposure across the country has probably played a significant role in worsening mental health in ways that had previously been unappreciated and invisible,” study investigator Aaron Reuben, PhD, assistant professor of clinical neuropsychology at the University of Virginia, Charlottesville, said in an interview.

However, the investigators emphasized that the study only establishes an association and not a causal relationship between leaded gas exposure and subsequent psychopathology.

The findings were published online on December 4 in The Journal of Child Psychology and Psychiatry.

 

Lead Astray?

Leaded gasoline was first used in the 1920s to stop engine knocking and improve performance. Despite early evidence of neurotoxicity its use continued until 1996 when it was banned.

The investigators noted that over half of the current US population was exposed to adverse lead levels from gasoline in childhood. However, they added the total contribution of childhood lead exposure to the population’s mental health and personality has not previously been evaluated.

For the study, the researchers combined serial, cross-sectional data on blood lead levels (BLLs) from the National Health and Nutrition Examination Survey and integrated it with historical data on gasoline usage, allowing them to estimate childhood BLLs in the United States from 1940 to 2015.

They calculated the impact of lead exposure on mental health using general psychopathology factor points, also referred to as mental illness points, which function similarly to IQ points.

These measures used were based on a prior study led by Reuben in 2019 from a New Zealand cohort and a study by a different group that followed a longitudinal birth cohort in Chicago .

Using these data, the researchers calculated population-level elevations in mental health symptoms on the basis of lead exposure and five key psychiatric outcomes in the US population.

These included general psychopathology, which reflects an individual’s overall liability to mental disorders and was scaled to match IQ scores with a mean of 100 and an SD of 15.

They also evaluated symptoms of internalizing disorders including anxiety and depression and ADHD and standardized them to a mean of 0 and an SD of 1.

The researchers also looked at differences in the personality traits of neuroticism, which relate to emotional instability and conscientiousness and reflect organization and responsibility. Both of these were assessed using similar standardized scales.

 

151 Million Excess Cases of Mental Illness

Using this approach, the researchers were able to assess the historical and long-term implications of lead exposure on mental health and personality traits in the US population over time.

Results showed that during the peak era of leaded gasoline in the United States, children were routinely exposed to lead levels three to six times higher than the current reference point for clinical concern (3.5 μg/dL of blood), the authors noted.

While the United States banned leaded gasoline in 1996, lead can still be present in water pipes, old paint, and soil. The Centers for Disease Control and Prevention cautions that no BLLs are safe.

The investigators found that between 1940 and 2015, the US population gained 602 million general psychopathology points, which the investigators said equates to 151 million excess instances of mental disorders that are primarily, but not completely, attributable to early life exposure to leaded gasoline.

“Assuming that published lead-psychopathology associations are causal and not purely correlational, we estimate that by 2015, the US population had gained 602 million General Psychopathology factor points because of exposure arising from leaded gasoline, reflecting a 0.13 standard deviation increase in overall liability to mental illness in the population and an estimated 151 million excess mental disorders attributable to lead exposure,” the researchers wrote.

Specific effects included a 0.64 SD increase in anxiety and depression symptoms, a 0.42 SD increase in ADHD symptoms, a 0.14 SD increase in ADHD symptoms, a 0.14 SD increase in emotional instability (neuroticism), and a 0.20 SD decrease in traits like organization and responsibility (conscientiousness).

These mental health and personality changes were not distributed evenly among the generations, most significant in those born between 1966 and 1986, the investigators reported.

For example, children between 1966 and 1970, the period when leaded gasoline use was at its peak, had BLLs > 5 μg/dL and experienced a 1.75 SD increase in internalizing symptoms and a 1.17 SD increase in ADHD symptoms.

 

Assess Lead Risk

The study had several limitations. Causality could not be established, and the accuracy of the estimates relied on findings from the researchers’ two previous key studies.

However, the investigators noted that these findings have been replicated across multiple cohorts and settings. Additionally, the results may not be fully generalizable to the entire US population, as one study was based in New Zealand and the other in urban Chicago.

Reuben cautioned that even though gasoline and new paint no longer contain lead, exposure is still possible.

“We saw this most acutely in Flint, Michigan,” when aging water pipes exposed more than 100,000 residents to high lead levels in 2014. “This situation made us aware that thousands of communities are exposed to lead service lines.”

He recommended that physicians consider screening patients for lead exposure — both new and old. Experts estimate that 90% of lead in the body is stored in the skeleton and can be released back into the bloodstream over time, particularly in cases of calcium deficiency, pregnancy, or osteoporosis.

While reversing childhood lead exposure is not possible, Reuben noted that healthy lifestyle choices and multimodal interventions such as medication and therapy can effectively address and alleviate mental illness.

 

‘Legacy of Lead’

In a comment, Terrie Moffitt, PhD, who was not involved in the research, said the study “is important because it gives us a crystal ball to see into the future of children living with lead today.”

“It’s called the ‘legacy of lead,’ and what a legacy,” said Moffitt, professor in the Department of Psychology and Neuroscience, Nannerl O. Keohane University at Duke University in Durham, North Carolina.

Moffitt emphasized that children exposed to lead today often live in areas of poverty and disadvantage, making it difficult to disentangle the potential effects of lead exposure from those of childhood adversity that predispose individuals to mental illness.

“This study tells us about lead’s damage in an era when it was everywhere, not just in poor communities,” she said.

The study was funded by a fellowship from the National Institute of Environmental Health Sciences. Reuben and Moffitt reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Childhood exposure to leaded gasoline via car exhaust over the past 75 years is linked to 151 million excess cases of psychiatric disorders in the United States, new research suggested.

The data revealed that the group most heavily exposed to lead — individuals born between 1966 and 1986, commonly known as Generation X — experienced the biggest increases in mental health issues.

Within this cohort, those born between 1966 and 1970 were affected the most. This timeline, the investigators noted, aligns with the peak use of leaded gasoline during the mid-1960s and 1970s. Specifically for this group, overall mental health issues increase by 0.35 times the average, anxiety and depression by 1.75 times, and attention-deficit/hyperactivity disorder (ADHD) symptoms by 1.17 times.

“Lead exposure across the country has probably played a significant role in worsening mental health in ways that had previously been unappreciated and invisible,” study investigator Aaron Reuben, PhD, assistant professor of clinical neuropsychology at the University of Virginia, Charlottesville, said in an interview.

However, the investigators emphasized that the study only establishes an association and not a causal relationship between leaded gas exposure and subsequent psychopathology.

The findings were published online on December 4 in The Journal of Child Psychology and Psychiatry.

 

Lead Astray?

Leaded gasoline was first used in the 1920s to stop engine knocking and improve performance. Despite early evidence of neurotoxicity its use continued until 1996 when it was banned.

The investigators noted that over half of the current US population was exposed to adverse lead levels from gasoline in childhood. However, they added the total contribution of childhood lead exposure to the population’s mental health and personality has not previously been evaluated.

For the study, the researchers combined serial, cross-sectional data on blood lead levels (BLLs) from the National Health and Nutrition Examination Survey and integrated it with historical data on gasoline usage, allowing them to estimate childhood BLLs in the United States from 1940 to 2015.

They calculated the impact of lead exposure on mental health using general psychopathology factor points, also referred to as mental illness points, which function similarly to IQ points.

These measures used were based on a prior study led by Reuben in 2019 from a New Zealand cohort and a study by a different group that followed a longitudinal birth cohort in Chicago .

Using these data, the researchers calculated population-level elevations in mental health symptoms on the basis of lead exposure and five key psychiatric outcomes in the US population.

These included general psychopathology, which reflects an individual’s overall liability to mental disorders and was scaled to match IQ scores with a mean of 100 and an SD of 15.

They also evaluated symptoms of internalizing disorders including anxiety and depression and ADHD and standardized them to a mean of 0 and an SD of 1.

The researchers also looked at differences in the personality traits of neuroticism, which relate to emotional instability and conscientiousness and reflect organization and responsibility. Both of these were assessed using similar standardized scales.

 

151 Million Excess Cases of Mental Illness

Using this approach, the researchers were able to assess the historical and long-term implications of lead exposure on mental health and personality traits in the US population over time.

Results showed that during the peak era of leaded gasoline in the United States, children were routinely exposed to lead levels three to six times higher than the current reference point for clinical concern (3.5 μg/dL of blood), the authors noted.

While the United States banned leaded gasoline in 1996, lead can still be present in water pipes, old paint, and soil. The Centers for Disease Control and Prevention cautions that no BLLs are safe.

The investigators found that between 1940 and 2015, the US population gained 602 million general psychopathology points, which the investigators said equates to 151 million excess instances of mental disorders that are primarily, but not completely, attributable to early life exposure to leaded gasoline.

“Assuming that published lead-psychopathology associations are causal and not purely correlational, we estimate that by 2015, the US population had gained 602 million General Psychopathology factor points because of exposure arising from leaded gasoline, reflecting a 0.13 standard deviation increase in overall liability to mental illness in the population and an estimated 151 million excess mental disorders attributable to lead exposure,” the researchers wrote.

Specific effects included a 0.64 SD increase in anxiety and depression symptoms, a 0.42 SD increase in ADHD symptoms, a 0.14 SD increase in ADHD symptoms, a 0.14 SD increase in emotional instability (neuroticism), and a 0.20 SD decrease in traits like organization and responsibility (conscientiousness).

These mental health and personality changes were not distributed evenly among the generations, most significant in those born between 1966 and 1986, the investigators reported.

For example, children between 1966 and 1970, the period when leaded gasoline use was at its peak, had BLLs > 5 μg/dL and experienced a 1.75 SD increase in internalizing symptoms and a 1.17 SD increase in ADHD symptoms.

 

Assess Lead Risk

The study had several limitations. Causality could not be established, and the accuracy of the estimates relied on findings from the researchers’ two previous key studies.

However, the investigators noted that these findings have been replicated across multiple cohorts and settings. Additionally, the results may not be fully generalizable to the entire US population, as one study was based in New Zealand and the other in urban Chicago.

Reuben cautioned that even though gasoline and new paint no longer contain lead, exposure is still possible.

“We saw this most acutely in Flint, Michigan,” when aging water pipes exposed more than 100,000 residents to high lead levels in 2014. “This situation made us aware that thousands of communities are exposed to lead service lines.”

He recommended that physicians consider screening patients for lead exposure — both new and old. Experts estimate that 90% of lead in the body is stored in the skeleton and can be released back into the bloodstream over time, particularly in cases of calcium deficiency, pregnancy, or osteoporosis.

While reversing childhood lead exposure is not possible, Reuben noted that healthy lifestyle choices and multimodal interventions such as medication and therapy can effectively address and alleviate mental illness.

 

‘Legacy of Lead’

In a comment, Terrie Moffitt, PhD, who was not involved in the research, said the study “is important because it gives us a crystal ball to see into the future of children living with lead today.”

“It’s called the ‘legacy of lead,’ and what a legacy,” said Moffitt, professor in the Department of Psychology and Neuroscience, Nannerl O. Keohane University at Duke University in Durham, North Carolina.

Moffitt emphasized that children exposed to lead today often live in areas of poverty and disadvantage, making it difficult to disentangle the potential effects of lead exposure from those of childhood adversity that predispose individuals to mental illness.

“This study tells us about lead’s damage in an era when it was everywhere, not just in poor communities,” she said.

The study was funded by a fellowship from the National Institute of Environmental Health Sciences. Reuben and Moffitt reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

There has been a lot of talk about polarization in America in the past year and how hard it can be to talk with someone with a different world view. It also seems that the COVID pandemic and a move to non–face-to-face communication has eroded social skills, increased disinformation, and made people irritable. As pediatric providers dealing with all kinds of people we have to increasingly deal with difficult communications.

We pediatric providers tend to be a friendly bunch with a mission of helping the health and well-being of children whose problems are no fault of their own. What’s not to like about us? Hence, one of the most difficult situations is a parent approaching us in anger. [All that follows also applies generally to adults, teens, and children but I here focus on parents.]

 

Health problems are often very frustrating. Parents mainly want their child’s problem fixed, yet that is not easy. Frustration with the health condition is compounded by having to wait, costs for care, life interruption, and confusing information. Anger and aggression are natural results of frustration (remember the Frustration-Aggression paradigm in animals?). Frustration is cumulative — a health problem may be the last straw, especially when social stressors or past trauma, also out of their control, were already present. Individuals with mental disorders or substance use are especially vulnerable to anger reactions.

 

Allaying Anger

As providers, we don’t know how anger may have been reinforced in the individual’s past. Anger may have scared others into giving in to them and thus became a familiar weapon. Sometimes angry outbursts get people to the front of the line. Expressing anger is also a kind of relief valve for emotions. Acknowledging that their situation is “very upsetting” and “frustrating” and that you will try to get a solution is the first step in effective communication.

Anger also comes from anxiety or fear. Anxiety is often a missed cause of childhood aggressive behavior. Parents are scared about poor short-and long-term outcomes of health problems in their child. Asking “What worries you the most about this illness?” or “What have you heard about this illness?” can elicit reports of fears you may be able to debunk or put in perspective. 

Keeping their child healthy and safe are parents’ top priorities, so feeling helpless and out of control when an illness or injury occurs is very disturbing. Being a good parent is partly driven by guilt, which may be unrealistic, or from omission (eg, did not bring the child in sooner), or commission (eg, shouldn’t have taken her to that birthday party where she caught it). This is where you may normalize their actions such as saying “a child really can’t grow up in a bubble” or “symptoms can mean many things. I usually tell parents they don’t need to call unless the temperature is over 101,” for example. If appropriate, you might clarify what actions they should take in the future and provide a handout or instructions for sources of reliable information (and perhaps what is unreliable, such as TikTok!) to give them more power. 

Feeling helpless may also evoke memories from the past when, as a child themselves, they were not able to help a loved one suffering from an accident or a health or mental health issue. They may have been helpless in the face of bullying, domestic violence, or racism. Even a hint of helplessness now can tap into the previous emotions, accelerating their reactivity. Promising to “work on this together” lends them your agency. 

Of course, the main thing angry parents need is to have their child’s issue resolved. But this may not be a quick fix, especially if they are too incensed to cooperate. But what we can always do is address their need to be heard — both in content and emotion — and to help them regain a sense of control.

 

Pacing Can Help

One strategy that may seem counterintuitive is called “pacing.” Instead of begging the parent to calm down, which denigrates their strong feelings, we can echo their concerns while mirroring their emotions (within limits) to demonstrate that we understand them. Mirroring emotions may include your physical posture, volume and speed of speech, as well as use of similar sensory modalities. As for the modality component, you may notice that people tend to use visual, auditory or kinesthetic (feeling or action) words. So, for example, for an angry parent “screaming that no one has looked at the lab results yet” we might posture as they do, increase our volume, and use visual words such as saying “You are upset because you don’t see anyone looking over the labs in all this time.” As you hear more, you can continue to paraphrase and summarize what they are saying including their examples or wording. You can then change your own tone and posture progressively downshifting, bringing them along, and establishing rapport as they can tell that you are understanding them. Validating their emotions does not mean you have to agree with what they are saying; it demonstrates that you hear them.

Other strategies to demonstrate listening that can be helpful include sitting down side by side, and taking notes they can see, asking if you are getting the details correct. Using open-ended questions to elicit answers other than yes/no conveys openness to hear their story and may also reveal some of the causes for the upset. Sitting side by side conveys collaboration, whereas face to face implies more confrontation. Keep your arms down and arms and legs uncrossed and your head nodding and tilted somewhat down. These positions and verbal techniques demonstrate that you are listening to both their content and feelings. 

 

Next Steps

The other main component to communication with an angry parent is providing action on the issue, especially involving them in a way that gives them some sense of control. Once they can tell that you understand them, it is then key to stay focused on solutions, bringing the discussion back if it veers off. There may be things they can do or you can do together such as log in to their portal, get on the phone with a relevant staff person such as a referral coordinator, or set a time for a follow-up appointment or call. Any action step they can do, even asking that they record a temperature every 6 hours, reduces helplessness.

It is crucial to elicit the parents’ criteria for satisfaction of their complaint. You may try asking: “What would tell you that your child’s problem is being adequately addressed?” Write down these criteria as part of the overall plan, making sure they are detailed, measurable, feasible, time related, and relevant. Include actions for the parent to take, if possible. By setting criteria and times for follow-up you establish accountability that also gives them a sense of control. 

There are certain communications that can make things worse with an angry parent, some of which you may not even know occurred. Their anger may well have sparked a reaction in our staff, who are getting it full force before we even start our visit. Not only you but also your staff need to avoid making excuses for what happened (or didn’t happen) to the patient, blame the family for the child’s issue, imply that the parent’s feelings are invalid, or react as though their anger was a personal affront. 

 

Setting Boundaries

There are certainly times when a parent’s behavior is unacceptable or even dangerous. It is important to have policies about what action to take so that we can verbally refer to these, if needed. We should all avoid threatening expulsion from the practice or calling security. Instead, assertively state the boundaries and rules and tell them what will happen if the behavior continues or exceeds a limit, such as frightening other patients or damaging equipment. It is essential to use respectful language and address them by name and certainly not make comments about them personally or criticize them, as these raise defensiveness. Suggesting they or you “take a break,” give them “some space” for a few minutes in a safe private room, or leave and come back in 15 minutes allows the upset parent to save face and gather themselves. All these things also work with children and teens. 

Health care is stressful, especially with short staffing, and is often intensely personal and emotional. The human struggles we deal with may also be present in our own and our staff’s experiences. Mastering skills for interacting with angry parents can strengthen our relationships with them, our staff, and even our understanding of ourselves.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at pdnews@mdedge.com.

There has been a lot of talk about polarization in America in the past year and how hard it can be to talk with someone with a different world view. It also seems that the COVID pandemic and a move to non–face-to-face communication has eroded social skills, increased disinformation, and made people irritable. As pediatric providers dealing with all kinds of people we have to increasingly deal with difficult communications.

We pediatric providers tend to be a friendly bunch with a mission of helping the health and well-being of children whose problems are no fault of their own. What’s not to like about us? Hence, one of the most difficult situations is a parent approaching us in anger. [All that follows also applies generally to adults, teens, and children but I here focus on parents.]

 

Health problems are often very frustrating. Parents mainly want their child’s problem fixed, yet that is not easy. Frustration with the health condition is compounded by having to wait, costs for care, life interruption, and confusing information. Anger and aggression are natural results of frustration (remember the Frustration-Aggression paradigm in animals?). Frustration is cumulative — a health problem may be the last straw, especially when social stressors or past trauma, also out of their control, were already present. Individuals with mental disorders or substance use are especially vulnerable to anger reactions.

 

Allaying Anger

As providers, we don’t know how anger may have been reinforced in the individual’s past. Anger may have scared others into giving in to them and thus became a familiar weapon. Sometimes angry outbursts get people to the front of the line. Expressing anger is also a kind of relief valve for emotions. Acknowledging that their situation is “very upsetting” and “frustrating” and that you will try to get a solution is the first step in effective communication.

Anger also comes from anxiety or fear. Anxiety is often a missed cause of childhood aggressive behavior. Parents are scared about poor short-and long-term outcomes of health problems in their child. Asking “What worries you the most about this illness?” or “What have you heard about this illness?” can elicit reports of fears you may be able to debunk or put in perspective. 

Keeping their child healthy and safe are parents’ top priorities, so feeling helpless and out of control when an illness or injury occurs is very disturbing. Being a good parent is partly driven by guilt, which may be unrealistic, or from omission (eg, did not bring the child in sooner), or commission (eg, shouldn’t have taken her to that birthday party where she caught it). This is where you may normalize their actions such as saying “a child really can’t grow up in a bubble” or “symptoms can mean many things. I usually tell parents they don’t need to call unless the temperature is over 101,” for example. If appropriate, you might clarify what actions they should take in the future and provide a handout or instructions for sources of reliable information (and perhaps what is unreliable, such as TikTok!) to give them more power. 

Feeling helpless may also evoke memories from the past when, as a child themselves, they were not able to help a loved one suffering from an accident or a health or mental health issue. They may have been helpless in the face of bullying, domestic violence, or racism. Even a hint of helplessness now can tap into the previous emotions, accelerating their reactivity. Promising to “work on this together” lends them your agency. 

Of course, the main thing angry parents need is to have their child’s issue resolved. But this may not be a quick fix, especially if they are too incensed to cooperate. But what we can always do is address their need to be heard — both in content and emotion — and to help them regain a sense of control.

 

Pacing Can Help

One strategy that may seem counterintuitive is called “pacing.” Instead of begging the parent to calm down, which denigrates their strong feelings, we can echo their concerns while mirroring their emotions (within limits) to demonstrate that we understand them. Mirroring emotions may include your physical posture, volume and speed of speech, as well as use of similar sensory modalities. As for the modality component, you may notice that people tend to use visual, auditory or kinesthetic (feeling or action) words. So, for example, for an angry parent “screaming that no one has looked at the lab results yet” we might posture as they do, increase our volume, and use visual words such as saying “You are upset because you don’t see anyone looking over the labs in all this time.” As you hear more, you can continue to paraphrase and summarize what they are saying including their examples or wording. You can then change your own tone and posture progressively downshifting, bringing them along, and establishing rapport as they can tell that you are understanding them. Validating their emotions does not mean you have to agree with what they are saying; it demonstrates that you hear them.

Other strategies to demonstrate listening that can be helpful include sitting down side by side, and taking notes they can see, asking if you are getting the details correct. Using open-ended questions to elicit answers other than yes/no conveys openness to hear their story and may also reveal some of the causes for the upset. Sitting side by side conveys collaboration, whereas face to face implies more confrontation. Keep your arms down and arms and legs uncrossed and your head nodding and tilted somewhat down. These positions and verbal techniques demonstrate that you are listening to both their content and feelings. 

 

Next Steps

The other main component to communication with an angry parent is providing action on the issue, especially involving them in a way that gives them some sense of control. Once they can tell that you understand them, it is then key to stay focused on solutions, bringing the discussion back if it veers off. There may be things they can do or you can do together such as log in to their portal, get on the phone with a relevant staff person such as a referral coordinator, or set a time for a follow-up appointment or call. Any action step they can do, even asking that they record a temperature every 6 hours, reduces helplessness.

It is crucial to elicit the parents’ criteria for satisfaction of their complaint. You may try asking: “What would tell you that your child’s problem is being adequately addressed?” Write down these criteria as part of the overall plan, making sure they are detailed, measurable, feasible, time related, and relevant. Include actions for the parent to take, if possible. By setting criteria and times for follow-up you establish accountability that also gives them a sense of control. 

There are certain communications that can make things worse with an angry parent, some of which you may not even know occurred. Their anger may well have sparked a reaction in our staff, who are getting it full force before we even start our visit. Not only you but also your staff need to avoid making excuses for what happened (or didn’t happen) to the patient, blame the family for the child’s issue, imply that the parent’s feelings are invalid, or react as though their anger was a personal affront. 

 

Setting Boundaries

There are certainly times when a parent’s behavior is unacceptable or even dangerous. It is important to have policies about what action to take so that we can verbally refer to these, if needed. We should all avoid threatening expulsion from the practice or calling security. Instead, assertively state the boundaries and rules and tell them what will happen if the behavior continues or exceeds a limit, such as frightening other patients or damaging equipment. It is essential to use respectful language and address them by name and certainly not make comments about them personally or criticize them, as these raise defensiveness. Suggesting they or you “take a break,” give them “some space” for a few minutes in a safe private room, or leave and come back in 15 minutes allows the upset parent to save face and gather themselves. All these things also work with children and teens. 

Health care is stressful, especially with short staffing, and is often intensely personal and emotional. The human struggles we deal with may also be present in our own and our staff’s experiences. Mastering skills for interacting with angry parents can strengthen our relationships with them, our staff, and even our understanding of ourselves.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at pdnews@mdedge.com.

There has been a lot of talk about polarization in America in the past year and how hard it can be to talk with someone with a different world view. It also seems that the COVID pandemic and a move to non–face-to-face communication has eroded social skills, increased disinformation, and made people irritable. As pediatric providers dealing with all kinds of people we have to increasingly deal with difficult communications.

We pediatric providers tend to be a friendly bunch with a mission of helping the health and well-being of children whose problems are no fault of their own. What’s not to like about us? Hence, one of the most difficult situations is a parent approaching us in anger. [All that follows also applies generally to adults, teens, and children but I here focus on parents.]

 

Health problems are often very frustrating. Parents mainly want their child’s problem fixed, yet that is not easy. Frustration with the health condition is compounded by having to wait, costs for care, life interruption, and confusing information. Anger and aggression are natural results of frustration (remember the Frustration-Aggression paradigm in animals?). Frustration is cumulative — a health problem may be the last straw, especially when social stressors or past trauma, also out of their control, were already present. Individuals with mental disorders or substance use are especially vulnerable to anger reactions.

 

Allaying Anger

As providers, we don’t know how anger may have been reinforced in the individual’s past. Anger may have scared others into giving in to them and thus became a familiar weapon. Sometimes angry outbursts get people to the front of the line. Expressing anger is also a kind of relief valve for emotions. Acknowledging that their situation is “very upsetting” and “frustrating” and that you will try to get a solution is the first step in effective communication.

Anger also comes from anxiety or fear. Anxiety is often a missed cause of childhood aggressive behavior. Parents are scared about poor short-and long-term outcomes of health problems in their child. Asking “What worries you the most about this illness?” or “What have you heard about this illness?” can elicit reports of fears you may be able to debunk or put in perspective. 

Keeping their child healthy and safe are parents’ top priorities, so feeling helpless and out of control when an illness or injury occurs is very disturbing. Being a good parent is partly driven by guilt, which may be unrealistic, or from omission (eg, did not bring the child in sooner), or commission (eg, shouldn’t have taken her to that birthday party where she caught it). This is where you may normalize their actions such as saying “a child really can’t grow up in a bubble” or “symptoms can mean many things. I usually tell parents they don’t need to call unless the temperature is over 101,” for example. If appropriate, you might clarify what actions they should take in the future and provide a handout or instructions for sources of reliable information (and perhaps what is unreliable, such as TikTok!) to give them more power. 

Feeling helpless may also evoke memories from the past when, as a child themselves, they were not able to help a loved one suffering from an accident or a health or mental health issue. They may have been helpless in the face of bullying, domestic violence, or racism. Even a hint of helplessness now can tap into the previous emotions, accelerating their reactivity. Promising to “work on this together” lends them your agency. 

Of course, the main thing angry parents need is to have their child’s issue resolved. But this may not be a quick fix, especially if they are too incensed to cooperate. But what we can always do is address their need to be heard — both in content and emotion — and to help them regain a sense of control.

 

Pacing Can Help

One strategy that may seem counterintuitive is called “pacing.” Instead of begging the parent to calm down, which denigrates their strong feelings, we can echo their concerns while mirroring their emotions (within limits) to demonstrate that we understand them. Mirroring emotions may include your physical posture, volume and speed of speech, as well as use of similar sensory modalities. As for the modality component, you may notice that people tend to use visual, auditory or kinesthetic (feeling or action) words. So, for example, for an angry parent “screaming that no one has looked at the lab results yet” we might posture as they do, increase our volume, and use visual words such as saying “You are upset because you don’t see anyone looking over the labs in all this time.” As you hear more, you can continue to paraphrase and summarize what they are saying including their examples or wording. You can then change your own tone and posture progressively downshifting, bringing them along, and establishing rapport as they can tell that you are understanding them. Validating their emotions does not mean you have to agree with what they are saying; it demonstrates that you hear them.

Other strategies to demonstrate listening that can be helpful include sitting down side by side, and taking notes they can see, asking if you are getting the details correct. Using open-ended questions to elicit answers other than yes/no conveys openness to hear their story and may also reveal some of the causes for the upset. Sitting side by side conveys collaboration, whereas face to face implies more confrontation. Keep your arms down and arms and legs uncrossed and your head nodding and tilted somewhat down. These positions and verbal techniques demonstrate that you are listening to both their content and feelings. 

 

Next Steps

The other main component to communication with an angry parent is providing action on the issue, especially involving them in a way that gives them some sense of control. Once they can tell that you understand them, it is then key to stay focused on solutions, bringing the discussion back if it veers off. There may be things they can do or you can do together such as log in to their portal, get on the phone with a relevant staff person such as a referral coordinator, or set a time for a follow-up appointment or call. Any action step they can do, even asking that they record a temperature every 6 hours, reduces helplessness.

It is crucial to elicit the parents’ criteria for satisfaction of their complaint. You may try asking: “What would tell you that your child’s problem is being adequately addressed?” Write down these criteria as part of the overall plan, making sure they are detailed, measurable, feasible, time related, and relevant. Include actions for the parent to take, if possible. By setting criteria and times for follow-up you establish accountability that also gives them a sense of control. 

There are certain communications that can make things worse with an angry parent, some of which you may not even know occurred. Their anger may well have sparked a reaction in our staff, who are getting it full force before we even start our visit. Not only you but also your staff need to avoid making excuses for what happened (or didn’t happen) to the patient, blame the family for the child’s issue, imply that the parent’s feelings are invalid, or react as though their anger was a personal affront. 

 

Setting Boundaries

There are certainly times when a parent’s behavior is unacceptable or even dangerous. It is important to have policies about what action to take so that we can verbally refer to these, if needed. We should all avoid threatening expulsion from the practice or calling security. Instead, assertively state the boundaries and rules and tell them what will happen if the behavior continues or exceeds a limit, such as frightening other patients or damaging equipment. It is essential to use respectful language and address them by name and certainly not make comments about them personally or criticize them, as these raise defensiveness. Suggesting they or you “take a break,” give them “some space” for a few minutes in a safe private room, or leave and come back in 15 minutes allows the upset parent to save face and gather themselves. All these things also work with children and teens. 

Health care is stressful, especially with short staffing, and is often intensely personal and emotional. The human struggles we deal with may also be present in our own and our staff’s experiences. Mastering skills for interacting with angry parents can strengthen our relationships with them, our staff, and even our understanding of ourselves.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at pdnews@mdedge.com.

A 40-year-old woman presents for a wellness visit. She says that she feels well but admits to high levels of stress and occasional fatigue. She works about 60 hours per week as an executive in a finance company. In addition, she is married and has two children, ages 12 and 10 years. She says that she has no time for herself and has noticed that she gets frustrated faster than she used to, but she does not think she has depression. Her score on a Patient Health Questionnaire 9 (PHQ-9) is 5, indicating a low level of depression symptoms.

Regarding health habits, she has never used nicotine products. She reports having one to two alcoholic drinks per day, either wine or a cocktail, and has four drinks per day on a couple of weekend days per month (such as on “date night” with her spouse). She says she does not use any other drugs, including cannabis, and is not taking any medications.

Her vital signs and physical examination are unremarkable. You note that she had an evaluation with a complete blood count, comprehensive metabolic panel, and thyroid-stimulating hormone level performed 7 months ago, with normal results.

What would be the best next step in caring for this patient?

A. Ask her to consider talk therapy to address her fatigue and stress

B. Have her complete a tool (such as the AUDIT-C) to identify hazardous drinking

C. Consider prescribing a selective serotonin reuptake inhibitor

D. Repeat her previous labs, adding vitamin B12 and vitamin D levels

Dr. Vega’s Take

Although all of the answer choices above could apply to this patient, a more formal screening for problem drinking is the most important intervention to make now.

This patient’s story is not unique, particularly in the wake of the COVID-19 pandemic. According to data from the National Institute on Alcohol Abuse and Alcoholism, 64% and 61% of males and females, respectively, at least 12 years of age, reported consuming alcohol in 2023, and 21.7% of these individuals reported binge drinking. 

Alcohol consumption is taking an increasing toll on public health. Between 2016 and 2021, the number of US deaths caused by excessive alcohol use increased by 29%, to a total of 47.6 cases per 100,000 population. The death rate increased faster among females vs males.

The US Preventive Services Task Force (USPSTF) recommends screening for alcohol misuse among adults at least 18 years of age, with no specific interval for repeat screening. USPSTF does recommend two specific screening instruments because of their ease of use and accuracy: the Alcohol Use Disorders Identification Test–Consumption (AUDIT-C) and Single Alcohol Screening Question (SASQ): How many times in the past year have you had more than four drinks (for women) or five drinks (for men) in a day? 

The AUDIT-C features three questions about alcohol use, the amount of alcohol consumed, and the frequency of heavy alcohol use. The instrument is scored from 0 to 12, with a higher score indicating a high risk for problem drinking. Generally, an AUDIT-C score is considered a positive screen at a score of 4 for men and 3 for women. The SASQ focuses on the number of heavy drinking days in the past year, with a current cutoff of five drinks for men and four drinks for women and anyone age 65 years or older.

Both the AUDIT-C and SASQ should be followed up with a more extensive history to make the diagnosis of alcohol use disorder (AUD). The USPSTF also recommends at least brief follow-up counseling for adults with possible AUD, noting that the most common form of counseling is personalized normative feedback, which compares a patient’s alcohol use pattern with that of others. 

What is your practice in screening for AUD, and what have you found effective in counseling patients? I look forward to hearing your thoughts.

Dr. Vega is Health Sciences Clinical Professor, Family Medicine, University of California, Irvine. He reported a conflict of interest with McNeil Pharmaceuticals.

A version of this article first appeared on Medscape.com.

A 40-year-old woman presents for a wellness visit. She says that she feels well but admits to high levels of stress and occasional fatigue. She works about 60 hours per week as an executive in a finance company. In addition, she is married and has two children, ages 12 and 10 years. She says that she has no time for herself and has noticed that she gets frustrated faster than she used to, but she does not think she has depression. Her score on a Patient Health Questionnaire 9 (PHQ-9) is 5, indicating a low level of depression symptoms.

Regarding health habits, she has never used nicotine products. She reports having one to two alcoholic drinks per day, either wine or a cocktail, and has four drinks per day on a couple of weekend days per month (such as on “date night” with her spouse). She says she does not use any other drugs, including cannabis, and is not taking any medications.

Her vital signs and physical examination are unremarkable. You note that she had an evaluation with a complete blood count, comprehensive metabolic panel, and thyroid-stimulating hormone level performed 7 months ago, with normal results.

What would be the best next step in caring for this patient?

A. Ask her to consider talk therapy to address her fatigue and stress

B. Have her complete a tool (such as the AUDIT-C) to identify hazardous drinking

C. Consider prescribing a selective serotonin reuptake inhibitor

D. Repeat her previous labs, adding vitamin B12 and vitamin D levels

Dr. Vega’s Take

Although all of the answer choices above could apply to this patient, a more formal screening for problem drinking is the most important intervention to make now.

This patient’s story is not unique, particularly in the wake of the COVID-19 pandemic. According to data from the National Institute on Alcohol Abuse and Alcoholism, 64% and 61% of males and females, respectively, at least 12 years of age, reported consuming alcohol in 2023, and 21.7% of these individuals reported binge drinking. 

Alcohol consumption is taking an increasing toll on public health. Between 2016 and 2021, the number of US deaths caused by excessive alcohol use increased by 29%, to a total of 47.6 cases per 100,000 population. The death rate increased faster among females vs males.

The US Preventive Services Task Force (USPSTF) recommends screening for alcohol misuse among adults at least 18 years of age, with no specific interval for repeat screening. USPSTF does recommend two specific screening instruments because of their ease of use and accuracy: the Alcohol Use Disorders Identification Test–Consumption (AUDIT-C) and Single Alcohol Screening Question (SASQ): How many times in the past year have you had more than four drinks (for women) or five drinks (for men) in a day? 

The AUDIT-C features three questions about alcohol use, the amount of alcohol consumed, and the frequency of heavy alcohol use. The instrument is scored from 0 to 12, with a higher score indicating a high risk for problem drinking. Generally, an AUDIT-C score is considered a positive screen at a score of 4 for men and 3 for women. The SASQ focuses on the number of heavy drinking days in the past year, with a current cutoff of five drinks for men and four drinks for women and anyone age 65 years or older.

Both the AUDIT-C and SASQ should be followed up with a more extensive history to make the diagnosis of alcohol use disorder (AUD). The USPSTF also recommends at least brief follow-up counseling for adults with possible AUD, noting that the most common form of counseling is personalized normative feedback, which compares a patient’s alcohol use pattern with that of others. 

What is your practice in screening for AUD, and what have you found effective in counseling patients? I look forward to hearing your thoughts.

Dr. Vega is Health Sciences Clinical Professor, Family Medicine, University of California, Irvine. He reported a conflict of interest with McNeil Pharmaceuticals.

A version of this article first appeared on Medscape.com.

A 40-year-old woman presents for a wellness visit. She says that she feels well but admits to high levels of stress and occasional fatigue. She works about 60 hours per week as an executive in a finance company. In addition, she is married and has two children, ages 12 and 10 years. She says that she has no time for herself and has noticed that she gets frustrated faster than she used to, but she does not think she has depression. Her score on a Patient Health Questionnaire 9 (PHQ-9) is 5, indicating a low level of depression symptoms.

Regarding health habits, she has never used nicotine products. She reports having one to two alcoholic drinks per day, either wine or a cocktail, and has four drinks per day on a couple of weekend days per month (such as on “date night” with her spouse). She says she does not use any other drugs, including cannabis, and is not taking any medications.

Her vital signs and physical examination are unremarkable. You note that she had an evaluation with a complete blood count, comprehensive metabolic panel, and thyroid-stimulating hormone level performed 7 months ago, with normal results.

What would be the best next step in caring for this patient?

A. Ask her to consider talk therapy to address her fatigue and stress

B. Have her complete a tool (such as the AUDIT-C) to identify hazardous drinking

C. Consider prescribing a selective serotonin reuptake inhibitor

D. Repeat her previous labs, adding vitamin B12 and vitamin D levels

Dr. Vega’s Take

Although all of the answer choices above could apply to this patient, a more formal screening for problem drinking is the most important intervention to make now.

This patient’s story is not unique, particularly in the wake of the COVID-19 pandemic. According to data from the National Institute on Alcohol Abuse and Alcoholism, 64% and 61% of males and females, respectively, at least 12 years of age, reported consuming alcohol in 2023, and 21.7% of these individuals reported binge drinking. 

Alcohol consumption is taking an increasing toll on public health. Between 2016 and 2021, the number of US deaths caused by excessive alcohol use increased by 29%, to a total of 47.6 cases per 100,000 population. The death rate increased faster among females vs males.

The US Preventive Services Task Force (USPSTF) recommends screening for alcohol misuse among adults at least 18 years of age, with no specific interval for repeat screening. USPSTF does recommend two specific screening instruments because of their ease of use and accuracy: the Alcohol Use Disorders Identification Test–Consumption (AUDIT-C) and Single Alcohol Screening Question (SASQ): How many times in the past year have you had more than four drinks (for women) or five drinks (for men) in a day? 

The AUDIT-C features three questions about alcohol use, the amount of alcohol consumed, and the frequency of heavy alcohol use. The instrument is scored from 0 to 12, with a higher score indicating a high risk for problem drinking. Generally, an AUDIT-C score is considered a positive screen at a score of 4 for men and 3 for women. The SASQ focuses on the number of heavy drinking days in the past year, with a current cutoff of five drinks for men and four drinks for women and anyone age 65 years or older.

Both the AUDIT-C and SASQ should be followed up with a more extensive history to make the diagnosis of alcohol use disorder (AUD). The USPSTF also recommends at least brief follow-up counseling for adults with possible AUD, noting that the most common form of counseling is personalized normative feedback, which compares a patient’s alcohol use pattern with that of others. 

What is your practice in screening for AUD, and what have you found effective in counseling patients? I look forward to hearing your thoughts.

Dr. Vega is Health Sciences Clinical Professor, Family Medicine, University of California, Irvine. He reported a conflict of interest with McNeil Pharmaceuticals.

A version of this article first appeared on Medscape.com.