Clinical Psychiatry News

TOPLINE:

High-dose valproate is associated with weight gain in psychiatric patients, with the greatest gain reported in those taking ≥ 1300 mg/d, new data showed.

METHODOLOGY:

• The researchers used 1-year data from two longitudinal studies conducted between 2007 and 2022.
• The study included 215 patients (median age, 48 years; 50% female) who had been diagnosed with bipolar disorder (38%), schizoaffective disorders (26%), schizophrenia (17%), or other conditions (16%).
• The researchers used linear mixed-effect models and logistic regressions to analyze the association between doses of valproate and metabolic outcomes.

TAKEAWAY:

• Each 500-mg increase in valproate dose was associated with a weight increase of 0.52% per month over a year (P < .001), an association that was evident before and after 3 months of treatment.
• Weight gain was greatest for treatment durations of < 3 months (+0.56%, P < .001) compared with ≥ 3 months (+0.12%, P = .02).
• The greatest weight gain was observed in patients receiving doses ≥ 1300 mg/d, with a 0.50% increase in weight for each dose increment of 500 mg (P = .004).
• In men, each 500-mg dose was associated with an increase of 0.59%, while the trend in women was for an increase of 0.40% (P = .09).
• The researchers did not find associations between valproate doses and blood glucose, lipid levels, or blood pressure across a treatment period of 6 months.

IN PRACTICE:

“These findings underscore the need for clinicians to closely monitor patients on [valproate] for weight gain and to prescribe the lowest effective doses,” the authors wrote.

SOURCE:

Chin B. Eap, PhD, of the Unit of Pharmacogenetics and Clinical Psychopharmacology, Centre for Psychiatric Neuroscience, Department of Psychiatry, Lausanne University Hospital, University of Lausanne, and Hôpital de Cery, Prilly-Lausanne, Switzerland, was the senior and corresponding author of the study. It was published online in the Journal of Clinical Psychiatry.

LIMITATIONS:

The study demonstrates an association, not causation. Treatment compliance could not be verified, although the daily dose administered to hospitalized patients was available. The study did not include information regarding lifestyle that could affect weight gain, such as dietary habits, physical activity, and substance use.

DISCLOSURES:

This study was funded by the Swiss National Research Foundation. Dr. Eap has received honoraria for conferences from Forum pour la formation medicale, Janssen-Cilag, Lundbeck, Otsuka, Sandoz, Servier, Sunovion, Sysmex Suisse AG, Takeda, Vifor Pharma, and Zeller in the past 3 years.

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

TOPLINE:

High-dose valproate is associated with weight gain in psychiatric patients, with the greatest gain reported in those taking ≥ 1300 mg/d, new data showed.

METHODOLOGY:

• The researchers used 1-year data from two longitudinal studies conducted between 2007 and 2022.
• The study included 215 patients (median age, 48 years; 50% female) who had been diagnosed with bipolar disorder (38%), schizoaffective disorders (26%), schizophrenia (17%), or other conditions (16%).
• The researchers used linear mixed-effect models and logistic regressions to analyze the association between doses of valproate and metabolic outcomes.

TAKEAWAY:

• Each 500-mg increase in valproate dose was associated with a weight increase of 0.52% per month over a year (P < .001), an association that was evident before and after 3 months of treatment.
• Weight gain was greatest for treatment durations of < 3 months (+0.56%, P < .001) compared with ≥ 3 months (+0.12%, P = .02).
• The greatest weight gain was observed in patients receiving doses ≥ 1300 mg/d, with a 0.50% increase in weight for each dose increment of 500 mg (P = .004).
• In men, each 500-mg dose was associated with an increase of 0.59%, while the trend in women was for an increase of 0.40% (P = .09).
• The researchers did not find associations between valproate doses and blood glucose, lipid levels, or blood pressure across a treatment period of 6 months.

IN PRACTICE:

“These findings underscore the need for clinicians to closely monitor patients on [valproate] for weight gain and to prescribe the lowest effective doses,” the authors wrote.

SOURCE:

Chin B. Eap, PhD, of the Unit of Pharmacogenetics and Clinical Psychopharmacology, Centre for Psychiatric Neuroscience, Department of Psychiatry, Lausanne University Hospital, University of Lausanne, and Hôpital de Cery, Prilly-Lausanne, Switzerland, was the senior and corresponding author of the study. It was published online in the Journal of Clinical Psychiatry.

LIMITATIONS:

The study demonstrates an association, not causation. Treatment compliance could not be verified, although the daily dose administered to hospitalized patients was available. The study did not include information regarding lifestyle that could affect weight gain, such as dietary habits, physical activity, and substance use.

DISCLOSURES:

This study was funded by the Swiss National Research Foundation. Dr. Eap has received honoraria for conferences from Forum pour la formation medicale, Janssen-Cilag, Lundbeck, Otsuka, Sandoz, Servier, Sunovion, Sysmex Suisse AG, Takeda, Vifor Pharma, and Zeller in the past 3 years.

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

TOPLINE:

High-dose valproate is associated with weight gain in psychiatric patients, with the greatest gain reported in those taking ≥ 1300 mg/d, new data showed.

METHODOLOGY:

• The researchers used 1-year data from two longitudinal studies conducted between 2007 and 2022.
• The study included 215 patients (median age, 48 years; 50% female) who had been diagnosed with bipolar disorder (38%), schizoaffective disorders (26%), schizophrenia (17%), or other conditions (16%).
• The researchers used linear mixed-effect models and logistic regressions to analyze the association between doses of valproate and metabolic outcomes.

TAKEAWAY:

• Each 500-mg increase in valproate dose was associated with a weight increase of 0.52% per month over a year (P < .001), an association that was evident before and after 3 months of treatment.
• Weight gain was greatest for treatment durations of < 3 months (+0.56%, P < .001) compared with ≥ 3 months (+0.12%, P = .02).
• The greatest weight gain was observed in patients receiving doses ≥ 1300 mg/d, with a 0.50% increase in weight for each dose increment of 500 mg (P = .004).
• In men, each 500-mg dose was associated with an increase of 0.59%, while the trend in women was for an increase of 0.40% (P = .09).
• The researchers did not find associations between valproate doses and blood glucose, lipid levels, or blood pressure across a treatment period of 6 months.

IN PRACTICE:

“These findings underscore the need for clinicians to closely monitor patients on [valproate] for weight gain and to prescribe the lowest effective doses,” the authors wrote.

SOURCE:

Chin B. Eap, PhD, of the Unit of Pharmacogenetics and Clinical Psychopharmacology, Centre for Psychiatric Neuroscience, Department of Psychiatry, Lausanne University Hospital, University of Lausanne, and Hôpital de Cery, Prilly-Lausanne, Switzerland, was the senior and corresponding author of the study. It was published online in the Journal of Clinical Psychiatry.

LIMITATIONS:

The study demonstrates an association, not causation. Treatment compliance could not be verified, although the daily dose administered to hospitalized patients was available. The study did not include information regarding lifestyle that could affect weight gain, such as dietary habits, physical activity, and substance use.

DISCLOSURES:

This study was funded by the Swiss National Research Foundation. Dr. Eap has received honoraria for conferences from Forum pour la formation medicale, Janssen-Cilag, Lundbeck, Otsuka, Sandoz, Servier, Sunovion, Sysmex Suisse AG, Takeda, Vifor Pharma, and Zeller in the past 3 years.

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

DENVER — Upon entry into the open-label extension (OLE) of the pivotal trial that led to approval of lecanemab for Alzheimer’s disease, placebo patients failed to show any appreciable catch up to the benefit achieved in the experimental arm, according to a first report of 6-month OLE data.

Due to the steady disease progression observed after the switch of placebo to active therapy, the message of these data is that “early initiation of lecanemab is important,” according to Michael Irizarry, MD, the senior vice president of clinical research at Eisai Ltd, which markets lecanemab.

The 6-month OLE data along with data from a tau PET substudy were presented by Dr. Irizarry at the 2024 annual meeting of the American Academy of Neurology.

From the start of the OLE through the 6-month follow-up, the downward trajectory of cognitive function, as measured with the Clinical Dementia Rating – Sum of Boxes (CDR-SB), has been parallel for the lecanemab-start and switch arms. As a result, the degree of separation between active and placebo groups over the course of the OLE has remained unchanged from the end of the randomized trial.

This does not rule out any benefit in the switch arm, according to Dr. Irizarry. Although there was no discernible change in the trajectory of decline among placebo patients after they were switched to lecanemab, Dr. Irizarry postulated that this might overlook the greater likely decline over time with no treatment.

“There was no placebo group in the OLE to compare with those on active treatment,” he pointed out. He then juxtaposed data from the Alzheimer’s Disease Neuroimaging Initiative (ADNI). Over the same 6-month timeframe, these data show a hypothetical separation of the curves if no treatment had been received.

The 6-month OLE data provide a preliminary look at outcomes in a planned 4-year follow-up. At the end of the randomized CLARITY trial, the mean decline from the baseline CDR-SB score of 3.2, was 1.21 in the lecanemab group, translating into a 38% decline, and 1.66 in the placebo group, translating into about a 50% decline. Over the 6 months of OLE, there has been a further mean CDR-SB reduction of approximately 0.6 in both arms, suggesting a further 18% decline from baseline.
 

Additional Data

In the pivotal CLARITY trial, which was published a few months prior to regulatory approval early last year, 1785 patients were randomized to 10 mg/kg lecanemab or placebo infused every 2 weeks. At the end of 18 months, the superiority of lecanemab for the primary endpoint of adverse change in CDR-SB was highly significant (P < .001) as were the differences in key secondary endpoints, such as Alzheimer’s Disease Composite Score (P < .001).

Of those who participated in CLARITY, 1385 patients entered the OLE. Placebo patients were switched to lecanemab which is being maintained in all patients on the trial schedule of 10 mg/kg administered by intravenous infusion every 2 weeks.

In addition to the overall OLE 6-month data, which has not raised any new safety signals, Dr. Irizarry provided a new look at the PET TAU substudy with a focus on patients who entered the study with a low relative tau burden. Of the three classifications, which also included medium and high tau, as measured with positron-emission tomography (PET), the low tau group represented 41.2% of the 342 tau PET substudy participants. With only 2.9% entering the study with a high tau burden, almost all the others fell in the medium stratification.

Due to the potential for a lower therapeutic response, “patients with low Tau are often excluded from trials,” Dr. Irizarry said. But the sizable proportion of low tau patients has permitted an assessment of relative response with lecanemab, which turned out to be substantial.

“Consistent rates of clinical stability or improvements were observed regardless of baseline tau levels with the highest rates of improvements observed for the low tau group after 24 months of follow-up,” Dr. Irizarry reported.

In previously reported results from the tau PET substudy, lecanemab was shown to slow tau spread at least numerically in every section of the brain evaluated, including the frontal, cingulate, parietal, and whole cortical gray matter areas. The reductions reached significance for the medial temporal (P = .0024), meta temporal (P = .012), and temporal (P = .16) portions.

When most recently evaluated in the OLE, the CDR-SB score declined 38% less among those treated with lecanemab than those treated with placebo in the subgroup enrolled in the tau PET substudy.

Relative to those with intermediate or high tau, patients in the low tau had an even greater reduction in cognitive decline than those with higher tau burdens. Although Dr. Irizarry cautioned that greater baseline CDR-SB scores exaggerated the treatment effect in the low tau group, the message is that “a lecanemab treatment effect is seen even when baseline tau levels are low.”

Now, with the recent market withdrawal of aducanumab, another anti-amyloid monoclonal antibody that was previously approved for Alzheimer’s disease, lecanemab is the only therapy currently available for the goal of changing disease progression, not just modifying symptoms.
 

Looking Long Term

Both sets of data provide important messages for clinicians, according to Marcelo Matiello, MD, a physician investigator at Mass General Hospital and associate professor of neurology at Harvard Medical School, Boston.

“Clinicians are really looking for more data because this remains a relatively new drug,” he said. Both sets of findings presented by Dr. Irizarry “look good but the follow-up is still short, so I think everyone is still looking closely at long-term safety and efficacy.”

The need for continuous indefinite therapy is one concern that Dr. Matiello expressed. As moderator of the session in which these data were presented, Dr. Matiello specifically asked Dr. Irizarry if there are plans to explore whether periods without treatment might be a means to reduce the cost and burden of frequent infusions while preserving cognitive gains.

In response, Dr. Irizarry said that earlier studies showed rapid progression when lecanemab was stopped. On this basis, he thinks therapy must be maintained, but he did say that there are plans to look at less frequent dosing, such as once per month. He also said that a subcutaneous formulation in development might also reduce the burden of prolonged treatment.

Dr. Irizarry is an employee of Eisai Ltd., which manufacturers lecanemab. Dr. Matiello reports no potential conflicts of interest.

DENVER — Upon entry into the open-label extension (OLE) of the pivotal trial that led to approval of lecanemab for Alzheimer’s disease, placebo patients failed to show any appreciable catch up to the benefit achieved in the experimental arm, according to a first report of 6-month OLE data.

Due to the steady disease progression observed after the switch of placebo to active therapy, the message of these data is that “early initiation of lecanemab is important,” according to Michael Irizarry, MD, the senior vice president of clinical research at Eisai Ltd, which markets lecanemab.

The 6-month OLE data along with data from a tau PET substudy were presented by Dr. Irizarry at the 2024 annual meeting of the American Academy of Neurology.

From the start of the OLE through the 6-month follow-up, the downward trajectory of cognitive function, as measured with the Clinical Dementia Rating – Sum of Boxes (CDR-SB), has been parallel for the lecanemab-start and switch arms. As a result, the degree of separation between active and placebo groups over the course of the OLE has remained unchanged from the end of the randomized trial.

This does not rule out any benefit in the switch arm, according to Dr. Irizarry. Although there was no discernible change in the trajectory of decline among placebo patients after they were switched to lecanemab, Dr. Irizarry postulated that this might overlook the greater likely decline over time with no treatment.

“There was no placebo group in the OLE to compare with those on active treatment,” he pointed out. He then juxtaposed data from the Alzheimer’s Disease Neuroimaging Initiative (ADNI). Over the same 6-month timeframe, these data show a hypothetical separation of the curves if no treatment had been received.

The 6-month OLE data provide a preliminary look at outcomes in a planned 4-year follow-up. At the end of the randomized CLARITY trial, the mean decline from the baseline CDR-SB score of 3.2, was 1.21 in the lecanemab group, translating into a 38% decline, and 1.66 in the placebo group, translating into about a 50% decline. Over the 6 months of OLE, there has been a further mean CDR-SB reduction of approximately 0.6 in both arms, suggesting a further 18% decline from baseline.
 

Additional Data

In the pivotal CLARITY trial, which was published a few months prior to regulatory approval early last year, 1785 patients were randomized to 10 mg/kg lecanemab or placebo infused every 2 weeks. At the end of 18 months, the superiority of lecanemab for the primary endpoint of adverse change in CDR-SB was highly significant (P < .001) as were the differences in key secondary endpoints, such as Alzheimer’s Disease Composite Score (P < .001).

Of those who participated in CLARITY, 1385 patients entered the OLE. Placebo patients were switched to lecanemab which is being maintained in all patients on the trial schedule of 10 mg/kg administered by intravenous infusion every 2 weeks.

In addition to the overall OLE 6-month data, which has not raised any new safety signals, Dr. Irizarry provided a new look at the PET TAU substudy with a focus on patients who entered the study with a low relative tau burden. Of the three classifications, which also included medium and high tau, as measured with positron-emission tomography (PET), the low tau group represented 41.2% of the 342 tau PET substudy participants. With only 2.9% entering the study with a high tau burden, almost all the others fell in the medium stratification.

Due to the potential for a lower therapeutic response, “patients with low Tau are often excluded from trials,” Dr. Irizarry said. But the sizable proportion of low tau patients has permitted an assessment of relative response with lecanemab, which turned out to be substantial.

“Consistent rates of clinical stability or improvements were observed regardless of baseline tau levels with the highest rates of improvements observed for the low tau group after 24 months of follow-up,” Dr. Irizarry reported.

In previously reported results from the tau PET substudy, lecanemab was shown to slow tau spread at least numerically in every section of the brain evaluated, including the frontal, cingulate, parietal, and whole cortical gray matter areas. The reductions reached significance for the medial temporal (P = .0024), meta temporal (P = .012), and temporal (P = .16) portions.

When most recently evaluated in the OLE, the CDR-SB score declined 38% less among those treated with lecanemab than those treated with placebo in the subgroup enrolled in the tau PET substudy.

Relative to those with intermediate or high tau, patients in the low tau had an even greater reduction in cognitive decline than those with higher tau burdens. Although Dr. Irizarry cautioned that greater baseline CDR-SB scores exaggerated the treatment effect in the low tau group, the message is that “a lecanemab treatment effect is seen even when baseline tau levels are low.”

Now, with the recent market withdrawal of aducanumab, another anti-amyloid monoclonal antibody that was previously approved for Alzheimer’s disease, lecanemab is the only therapy currently available for the goal of changing disease progression, not just modifying symptoms.
 

Looking Long Term

Both sets of data provide important messages for clinicians, according to Marcelo Matiello, MD, a physician investigator at Mass General Hospital and associate professor of neurology at Harvard Medical School, Boston.

“Clinicians are really looking for more data because this remains a relatively new drug,” he said. Both sets of findings presented by Dr. Irizarry “look good but the follow-up is still short, so I think everyone is still looking closely at long-term safety and efficacy.”

The need for continuous indefinite therapy is one concern that Dr. Matiello expressed. As moderator of the session in which these data were presented, Dr. Matiello specifically asked Dr. Irizarry if there are plans to explore whether periods without treatment might be a means to reduce the cost and burden of frequent infusions while preserving cognitive gains.

In response, Dr. Irizarry said that earlier studies showed rapid progression when lecanemab was stopped. On this basis, he thinks therapy must be maintained, but he did say that there are plans to look at less frequent dosing, such as once per month. He also said that a subcutaneous formulation in development might also reduce the burden of prolonged treatment.

Dr. Irizarry is an employee of Eisai Ltd., which manufacturers lecanemab. Dr. Matiello reports no potential conflicts of interest.

DENVER — Upon entry into the open-label extension (OLE) of the pivotal trial that led to approval of lecanemab for Alzheimer’s disease, placebo patients failed to show any appreciable catch up to the benefit achieved in the experimental arm, according to a first report of 6-month OLE data.

Due to the steady disease progression observed after the switch of placebo to active therapy, the message of these data is that “early initiation of lecanemab is important,” according to Michael Irizarry, MD, the senior vice president of clinical research at Eisai Ltd, which markets lecanemab.

The 6-month OLE data along with data from a tau PET substudy were presented by Dr. Irizarry at the 2024 annual meeting of the American Academy of Neurology.

From the start of the OLE through the 6-month follow-up, the downward trajectory of cognitive function, as measured with the Clinical Dementia Rating – Sum of Boxes (CDR-SB), has been parallel for the lecanemab-start and switch arms. As a result, the degree of separation between active and placebo groups over the course of the OLE has remained unchanged from the end of the randomized trial.

This does not rule out any benefit in the switch arm, according to Dr. Irizarry. Although there was no discernible change in the trajectory of decline among placebo patients after they were switched to lecanemab, Dr. Irizarry postulated that this might overlook the greater likely decline over time with no treatment.

“There was no placebo group in the OLE to compare with those on active treatment,” he pointed out. He then juxtaposed data from the Alzheimer’s Disease Neuroimaging Initiative (ADNI). Over the same 6-month timeframe, these data show a hypothetical separation of the curves if no treatment had been received.

The 6-month OLE data provide a preliminary look at outcomes in a planned 4-year follow-up. At the end of the randomized CLARITY trial, the mean decline from the baseline CDR-SB score of 3.2, was 1.21 in the lecanemab group, translating into a 38% decline, and 1.66 in the placebo group, translating into about a 50% decline. Over the 6 months of OLE, there has been a further mean CDR-SB reduction of approximately 0.6 in both arms, suggesting a further 18% decline from baseline.
 

Additional Data

In the pivotal CLARITY trial, which was published a few months prior to regulatory approval early last year, 1785 patients were randomized to 10 mg/kg lecanemab or placebo infused every 2 weeks. At the end of 18 months, the superiority of lecanemab for the primary endpoint of adverse change in CDR-SB was highly significant (P < .001) as were the differences in key secondary endpoints, such as Alzheimer’s Disease Composite Score (P < .001).

Of those who participated in CLARITY, 1385 patients entered the OLE. Placebo patients were switched to lecanemab which is being maintained in all patients on the trial schedule of 10 mg/kg administered by intravenous infusion every 2 weeks.

In addition to the overall OLE 6-month data, which has not raised any new safety signals, Dr. Irizarry provided a new look at the PET TAU substudy with a focus on patients who entered the study with a low relative tau burden. Of the three classifications, which also included medium and high tau, as measured with positron-emission tomography (PET), the low tau group represented 41.2% of the 342 tau PET substudy participants. With only 2.9% entering the study with a high tau burden, almost all the others fell in the medium stratification.

Due to the potential for a lower therapeutic response, “patients with low Tau are often excluded from trials,” Dr. Irizarry said. But the sizable proportion of low tau patients has permitted an assessment of relative response with lecanemab, which turned out to be substantial.

“Consistent rates of clinical stability or improvements were observed regardless of baseline tau levels with the highest rates of improvements observed for the low tau group after 24 months of follow-up,” Dr. Irizarry reported.

In previously reported results from the tau PET substudy, lecanemab was shown to slow tau spread at least numerically in every section of the brain evaluated, including the frontal, cingulate, parietal, and whole cortical gray matter areas. The reductions reached significance for the medial temporal (P = .0024), meta temporal (P = .012), and temporal (P = .16) portions.

When most recently evaluated in the OLE, the CDR-SB score declined 38% less among those treated with lecanemab than those treated with placebo in the subgroup enrolled in the tau PET substudy.

Relative to those with intermediate or high tau, patients in the low tau had an even greater reduction in cognitive decline than those with higher tau burdens. Although Dr. Irizarry cautioned that greater baseline CDR-SB scores exaggerated the treatment effect in the low tau group, the message is that “a lecanemab treatment effect is seen even when baseline tau levels are low.”

Now, with the recent market withdrawal of aducanumab, another anti-amyloid monoclonal antibody that was previously approved for Alzheimer’s disease, lecanemab is the only therapy currently available for the goal of changing disease progression, not just modifying symptoms.
 

Looking Long Term

Both sets of data provide important messages for clinicians, according to Marcelo Matiello, MD, a physician investigator at Mass General Hospital and associate professor of neurology at Harvard Medical School, Boston.

“Clinicians are really looking for more data because this remains a relatively new drug,” he said. Both sets of findings presented by Dr. Irizarry “look good but the follow-up is still short, so I think everyone is still looking closely at long-term safety and efficacy.”

The need for continuous indefinite therapy is one concern that Dr. Matiello expressed. As moderator of the session in which these data were presented, Dr. Matiello specifically asked Dr. Irizarry if there are plans to explore whether periods without treatment might be a means to reduce the cost and burden of frequent infusions while preserving cognitive gains.

In response, Dr. Irizarry said that earlier studies showed rapid progression when lecanemab was stopped. On this basis, he thinks therapy must be maintained, but he did say that there are plans to look at less frequent dosing, such as once per month. He also said that a subcutaneous formulation in development might also reduce the burden of prolonged treatment.

Dr. Irizarry is an employee of Eisai Ltd., which manufacturers lecanemab. Dr. Matiello reports no potential conflicts of interest.

BALTIMORE — Patients who have complications after dermatologic cosmetic procedures are prone to high rates of a host of mental health issues, ranging from anxiety disorder and depression to body dysmorphic disorder (BDD) and posttraumatic stress disorder (PTSD), according to a survey-based study of patients with dermatology-related complications. 

The study used an anonymous 40-question survey circulated to a Facebook cosmetic complication support group. Seventy-one of 100 individuals completed the questionnaire, reporting significantly higher rates of mental health issues after their complications than before. Results were presented at the annual conference of the American Society for Laser Medicine and Surgery (ASLMS). Almost all the survey respondents (99%) were female, with 61% aged 25-44 years and 34% aged 45-64 years.

Taryn Murray, MD

“Cosmetic procedures have increased over the past decade, with procedures being increasingly performed by an evolving variety of providers,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, Cleveland, Ohio, told this news organization. “Appropriate patient assessment and counseling and proper procedure technique are important for obtaining safe and effective results. Complications may not only impact patients physically but can also be harmful to their mental health.”
 

Rise in Mental Health Issues

The study found that before respondents had the treatment that led to their complications, 16% reported a history of generalized anxiety disorder, 15% a history of depression, and 1% a history of either BDD or PTSD. Following the complication, 50% reported a positive depression screening, 63% a positive BDD Questionnaire – Dermatology Version, and 63% a positive Primary Care PTSD screen, Dr. Murray said. “Almost half of respondents (46%) reported thinking about their complication for more than 3 hours a day,” she said in presenting the results. 

Dr. Murray said the idea for the study grew out of her experience as a fellow working with Paul Friedman, MD, at the Dermatology and Laser Surgery Center at University of Texas Health in Houston.

“We were seeing a lot of complications,” Dr. Murray said in an interview. “Some of these were local. Some of these patients were flying in from out-of-state looking for help with the complication, and we could see what a mental and emotional burden this put on these patients. They were routinely in the office in tears saying it was interfering with their daily life, it was interfering with their job, saying they were going to lose their job, all because they were so distressed over what was happening to them.”

Yet, the research into psychological distress in patients with dermatologic complications is minimal, Dr. Murray added. “We think that body dysmorphic disorder is prevalent for patients seeking dermatology or plastic surgery services, but I don’t think either of the specialties do a great job in screening people for that when they come for treatment, so I think a lot of it goes undiagnosed. There’s been a trend looking at more at complications lately, but there’s been a gap in the literature.”

The treatments the patients in the survey had were microneedling with radiofrequency (29%), laser (24%), ultrasound for skin tightening (11%), radiofrequency for skin tightening (11%), microneedling (4%), chemical peel (3%), body contouring/sculpting (1%), and “other” (17%).

The study found that the largest share of procedures, 47%, were done by an esthetician/laser technician, followed by a nondermatologist physician (17%), a board-certified dermatologist (14%), an advanced practice provider (12%), and “other” (10%).

Self-reported complications included scarring (38%), hyperpigmentation (26%), erythema (24%), burn (23%), blisters (11%), and hypopigmentation (3%); 71% characterized their complications as “other,” and one respondent reported multiple complications.

“Respondents said they were satisfied with the previous cosmetic care they received,” Dr. Murray said during her presentation at the meeting. “And there was a consensus among the respondents that they did not feel adequately counseled on the risks of the procedure and that it did not meet their expectations and anticipated outcome.”
 

Take-Home Lesson

The lesson here is that practitioners who perform cosmetic procedures should be well-versed in the task and potential complications, Dr. Murray said in the interview. “If you’re going to be doing a procedure, make sure you know the proper techniques, the proper endpoints, and how to treat if you’re to have a complication,” she said. “If you don’t know how to treat a complication from the device, then you should think twice about using it.”

She also suggested screening patients for potentially undiagnosed mental health disorders. “It can play a role in the initial consultation and potentially any after-care they might need if there is a complication,” she said. “We may not have the adequate tools at this time to know how to best handle these patients and these scenarios, but hopefully my abstract will shed a little more light on it.”

She said she hopes her findings lead to more research in the future.

Asked to comment on the study, Jennifer Lin, MD, assistant professor of dermatology at Brigham and Women’s Hospital and Dana Farber Cancer Institute in Boston, Massachusetts, said one finding of the study stood out to her. “ I was very surprised from her dataset that patients think about it more than 3 hours a day,” she told this news organization. “That’s really significant. We talk about the side effects, but we don’t necessarily talk about the burden of how long the recovery will be or the psychological burden of potentially dealing with it.”

She noted that “there’s a bit of movement” toward developing guidelines for laser treatments, which would address the risk of complications. “That’s the goal: To have better guidelines to avoid these complications in the first place,” Dr. Lin said.

The study findings also point to a need for “premonitoring” individuals before procedures, she added. “We talked about patient selection and make sure someone doesn’t have body dysmorphic disorder, but we don’t formally screen for it,” she said. “We don’t our train our residents to screen for it. And I think doing more pre- and post-testing of how people are affected by laser treatment is going to become more important.”

Dr. Murray disclosed relationships with R2 Technologies. Dr. Lin had no relationships to disclose.

A version of this article appeared on Medscape.com.

BALTIMORE — Patients who have complications after dermatologic cosmetic procedures are prone to high rates of a host of mental health issues, ranging from anxiety disorder and depression to body dysmorphic disorder (BDD) and posttraumatic stress disorder (PTSD), according to a survey-based study of patients with dermatology-related complications. 

The study used an anonymous 40-question survey circulated to a Facebook cosmetic complication support group. Seventy-one of 100 individuals completed the questionnaire, reporting significantly higher rates of mental health issues after their complications than before. Results were presented at the annual conference of the American Society for Laser Medicine and Surgery (ASLMS). Almost all the survey respondents (99%) were female, with 61% aged 25-44 years and 34% aged 45-64 years.

Taryn Murray, MD

“Cosmetic procedures have increased over the past decade, with procedures being increasingly performed by an evolving variety of providers,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, Cleveland, Ohio, told this news organization. “Appropriate patient assessment and counseling and proper procedure technique are important for obtaining safe and effective results. Complications may not only impact patients physically but can also be harmful to their mental health.”
 

Rise in Mental Health Issues

The study found that before respondents had the treatment that led to their complications, 16% reported a history of generalized anxiety disorder, 15% a history of depression, and 1% a history of either BDD or PTSD. Following the complication, 50% reported a positive depression screening, 63% a positive BDD Questionnaire – Dermatology Version, and 63% a positive Primary Care PTSD screen, Dr. Murray said. “Almost half of respondents (46%) reported thinking about their complication for more than 3 hours a day,” she said in presenting the results. 

Dr. Murray said the idea for the study grew out of her experience as a fellow working with Paul Friedman, MD, at the Dermatology and Laser Surgery Center at University of Texas Health in Houston.

“We were seeing a lot of complications,” Dr. Murray said in an interview. “Some of these were local. Some of these patients were flying in from out-of-state looking for help with the complication, and we could see what a mental and emotional burden this put on these patients. They were routinely in the office in tears saying it was interfering with their daily life, it was interfering with their job, saying they were going to lose their job, all because they were so distressed over what was happening to them.”

Yet, the research into psychological distress in patients with dermatologic complications is minimal, Dr. Murray added. “We think that body dysmorphic disorder is prevalent for patients seeking dermatology or plastic surgery services, but I don’t think either of the specialties do a great job in screening people for that when they come for treatment, so I think a lot of it goes undiagnosed. There’s been a trend looking at more at complications lately, but there’s been a gap in the literature.”

The treatments the patients in the survey had were microneedling with radiofrequency (29%), laser (24%), ultrasound for skin tightening (11%), radiofrequency for skin tightening (11%), microneedling (4%), chemical peel (3%), body contouring/sculpting (1%), and “other” (17%).

The study found that the largest share of procedures, 47%, were done by an esthetician/laser technician, followed by a nondermatologist physician (17%), a board-certified dermatologist (14%), an advanced practice provider (12%), and “other” (10%).

Self-reported complications included scarring (38%), hyperpigmentation (26%), erythema (24%), burn (23%), blisters (11%), and hypopigmentation (3%); 71% characterized their complications as “other,” and one respondent reported multiple complications.

“Respondents said they were satisfied with the previous cosmetic care they received,” Dr. Murray said during her presentation at the meeting. “And there was a consensus among the respondents that they did not feel adequately counseled on the risks of the procedure and that it did not meet their expectations and anticipated outcome.”
 

Take-Home Lesson

The lesson here is that practitioners who perform cosmetic procedures should be well-versed in the task and potential complications, Dr. Murray said in the interview. “If you’re going to be doing a procedure, make sure you know the proper techniques, the proper endpoints, and how to treat if you’re to have a complication,” she said. “If you don’t know how to treat a complication from the device, then you should think twice about using it.”

She also suggested screening patients for potentially undiagnosed mental health disorders. “It can play a role in the initial consultation and potentially any after-care they might need if there is a complication,” she said. “We may not have the adequate tools at this time to know how to best handle these patients and these scenarios, but hopefully my abstract will shed a little more light on it.”

She said she hopes her findings lead to more research in the future.

Asked to comment on the study, Jennifer Lin, MD, assistant professor of dermatology at Brigham and Women’s Hospital and Dana Farber Cancer Institute in Boston, Massachusetts, said one finding of the study stood out to her. “ I was very surprised from her dataset that patients think about it more than 3 hours a day,” she told this news organization. “That’s really significant. We talk about the side effects, but we don’t necessarily talk about the burden of how long the recovery will be or the psychological burden of potentially dealing with it.”

She noted that “there’s a bit of movement” toward developing guidelines for laser treatments, which would address the risk of complications. “That’s the goal: To have better guidelines to avoid these complications in the first place,” Dr. Lin said.

The study findings also point to a need for “premonitoring” individuals before procedures, she added. “We talked about patient selection and make sure someone doesn’t have body dysmorphic disorder, but we don’t formally screen for it,” she said. “We don’t our train our residents to screen for it. And I think doing more pre- and post-testing of how people are affected by laser treatment is going to become more important.”

Dr. Murray disclosed relationships with R2 Technologies. Dr. Lin had no relationships to disclose.

A version of this article appeared on Medscape.com.

BALTIMORE — Patients who have complications after dermatologic cosmetic procedures are prone to high rates of a host of mental health issues, ranging from anxiety disorder and depression to body dysmorphic disorder (BDD) and posttraumatic stress disorder (PTSD), according to a survey-based study of patients with dermatology-related complications. 

The study used an anonymous 40-question survey circulated to a Facebook cosmetic complication support group. Seventy-one of 100 individuals completed the questionnaire, reporting significantly higher rates of mental health issues after their complications than before. Results were presented at the annual conference of the American Society for Laser Medicine and Surgery (ASLMS). Almost all the survey respondents (99%) were female, with 61% aged 25-44 years and 34% aged 45-64 years.

Taryn Murray, MD

“Cosmetic procedures have increased over the past decade, with procedures being increasingly performed by an evolving variety of providers,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, Cleveland, Ohio, told this news organization. “Appropriate patient assessment and counseling and proper procedure technique are important for obtaining safe and effective results. Complications may not only impact patients physically but can also be harmful to their mental health.”
 

Rise in Mental Health Issues

The study found that before respondents had the treatment that led to their complications, 16% reported a history of generalized anxiety disorder, 15% a history of depression, and 1% a history of either BDD or PTSD. Following the complication, 50% reported a positive depression screening, 63% a positive BDD Questionnaire – Dermatology Version, and 63% a positive Primary Care PTSD screen, Dr. Murray said. “Almost half of respondents (46%) reported thinking about their complication for more than 3 hours a day,” she said in presenting the results. 

Dr. Murray said the idea for the study grew out of her experience as a fellow working with Paul Friedman, MD, at the Dermatology and Laser Surgery Center at University of Texas Health in Houston.

“We were seeing a lot of complications,” Dr. Murray said in an interview. “Some of these were local. Some of these patients were flying in from out-of-state looking for help with the complication, and we could see what a mental and emotional burden this put on these patients. They were routinely in the office in tears saying it was interfering with their daily life, it was interfering with their job, saying they were going to lose their job, all because they were so distressed over what was happening to them.”

Yet, the research into psychological distress in patients with dermatologic complications is minimal, Dr. Murray added. “We think that body dysmorphic disorder is prevalent for patients seeking dermatology or plastic surgery services, but I don’t think either of the specialties do a great job in screening people for that when they come for treatment, so I think a lot of it goes undiagnosed. There’s been a trend looking at more at complications lately, but there’s been a gap in the literature.”

The treatments the patients in the survey had were microneedling with radiofrequency (29%), laser (24%), ultrasound for skin tightening (11%), radiofrequency for skin tightening (11%), microneedling (4%), chemical peel (3%), body contouring/sculpting (1%), and “other” (17%).

The study found that the largest share of procedures, 47%, were done by an esthetician/laser technician, followed by a nondermatologist physician (17%), a board-certified dermatologist (14%), an advanced practice provider (12%), and “other” (10%).

Self-reported complications included scarring (38%), hyperpigmentation (26%), erythema (24%), burn (23%), blisters (11%), and hypopigmentation (3%); 71% characterized their complications as “other,” and one respondent reported multiple complications.

“Respondents said they were satisfied with the previous cosmetic care they received,” Dr. Murray said during her presentation at the meeting. “And there was a consensus among the respondents that they did not feel adequately counseled on the risks of the procedure and that it did not meet their expectations and anticipated outcome.”
 

Take-Home Lesson

The lesson here is that practitioners who perform cosmetic procedures should be well-versed in the task and potential complications, Dr. Murray said in the interview. “If you’re going to be doing a procedure, make sure you know the proper techniques, the proper endpoints, and how to treat if you’re to have a complication,” she said. “If you don’t know how to treat a complication from the device, then you should think twice about using it.”

She also suggested screening patients for potentially undiagnosed mental health disorders. “It can play a role in the initial consultation and potentially any after-care they might need if there is a complication,” she said. “We may not have the adequate tools at this time to know how to best handle these patients and these scenarios, but hopefully my abstract will shed a little more light on it.”

She said she hopes her findings lead to more research in the future.

Asked to comment on the study, Jennifer Lin, MD, assistant professor of dermatology at Brigham and Women’s Hospital and Dana Farber Cancer Institute in Boston, Massachusetts, said one finding of the study stood out to her. “ I was very surprised from her dataset that patients think about it more than 3 hours a day,” she told this news organization. “That’s really significant. We talk about the side effects, but we don’t necessarily talk about the burden of how long the recovery will be or the psychological burden of potentially dealing with it.”

She noted that “there’s a bit of movement” toward developing guidelines for laser treatments, which would address the risk of complications. “That’s the goal: To have better guidelines to avoid these complications in the first place,” Dr. Lin said.

The study findings also point to a need for “premonitoring” individuals before procedures, she added. “We talked about patient selection and make sure someone doesn’t have body dysmorphic disorder, but we don’t formally screen for it,” she said. “We don’t our train our residents to screen for it. And I think doing more pre- and post-testing of how people are affected by laser treatment is going to become more important.”

Dr. Murray disclosed relationships with R2 Technologies. Dr. Lin had no relationships to disclose.

A version of this article appeared on Medscape.com.

Combining D-limonene, a naturally occurring terpene in cannabis, with delta-9-tetrahydrocannabinol (THC), the primary psychoactive component in cannabis, may mitigate THC-induced anxiety, new data from a small study suggested.

Participants who inhaled vaporized D-limonene and THC reported significantly greater decreases in anxiogenic effects than did people who received either component alone or a placebo. Reductions were greater as the dose of the D-limonene was increased.

Investigators noted that the findings could have implications for the use of medicinal or recreational cannabis, which has increased in recent years due to state legalization efforts.

“People use cannabis to help reduce anxiety, depression, and posttraumatic stress disorder, but since THC levels vary widely, if a person overshoots their tolerance of THC, cannabis can induce anxiety rather than relieve it,” senior investigator Ryan Vandrey, PhD, professor of psychiatry and behavioral sciences, Johns Hopkins School of Medicine, Baltimore, said in a news release.

“Our study demonstrates that D-limonene can modulate the effects of THC in a meaningful way and make THC more tolerable to people using it for both therapeutic and non-therapeutic purposes,” he added.

The study was published online in Drug and Alcohol Dependence.
 

Entourage Theory

Cannabis legalization has opened the door to an increased range of medicinal and nonmedicinal uses, but its benefits can be limited by the anxiety and panic some people experience with its use, investigators noted.

Many cannabis plants have been bred to contain higher concentrations of THC, with some dispensaries selling cannabis with more than 20%-30% THC. The plants often include cannabidiol, “minor” cannabinoids, and terpenes, such as D-limonene.

Prior studies pointed to THC as the cause of acute behavioral and psychoactive effects some cannabis users experience. However, a new, untested theory, the “cannabis entourage effect theory,” suggested other components in cannabis, including D-limonene, may contribute to the anxiogenic symptoms.

“We were motivated by scientific publications that hypothesized D-limonene can attenuate the acute anxiogenic effects of cannabis, but for which empirical data did not exist,” Dr. Vandrey said.

Investigators designed a small double-blind, within-subjects crossover study of 20 healthy adults (median age, 26 years; 50% men). About half of participants were Caucasian/non-Hispanic, 30% African American/non-Hispanic, 10% Caucasian/Hispanic, and 10% Asian/non-Hispanic.

All participants completed nine outpatient drug administration sessions, during which they inhaled vaporized D-limonene alone (1 or 5 mg), THC alone (15 or 30 mg), the same doses of THC and D-limonene together, or placebo.

Primary outcomes included subjective drug effects, measured with the Drug Effect Questionnaire (DEQ) and the 20-item state subscale of the State-Trait Anxiety Inventory (STAI-S). Investigators also measured cognitive/psychomotor performance with the Digit Symbol Substitution Task (DSST) and the Paced Serial Addition Task.

Vital signs such as heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), and plasma D-limonene and THC concentrations were also tracked.

Participants’ responses were measured at baseline and then an additional nine times after initial exposure over the course of each 6-hour test session. Blood and urine samples were collected from participants before, during, and after each session.
 

First Evidence

There were no significant differences in outcomes between the D-limonene alone and placebo groups.

Receipt of 15- and 30-mg doses of THC alone was associated with subjective reports of acute cannabis exposure, including cognitive and physiological effects.

A treatment effect was observed for “anxious/nervous” (P < .01), “paranoid” (P < .01), and “heart racing” (P < .0001).

In planned comparisons, ratings of anxiety-like subjective effects qualitatively decreased as D-limonene dose increased, and concurrent administration of 30-mg THC plus 15-mg D-limonene significantly reduced ratings of “anxious/nervous” and “paranoid” on the DEQ compared to 30 mg of THC alone (P < .05).

Findings were similar on the composite score of the STAI-S, and although planned comparisons did not reach the threshold for statistical significance, reductions in anxiety approached significance in the THC plus D-limonene group compared with the THC alone condition (P = .08). The combination group also reported significantly lower subjective ratings of unpleasant drug effects than the THC alone group (P = .03).

In particular, a main effect of treatment was found for the anxious/nervous category on the DEQ (P < .01), as well as the “paranoid” (P < .01) and heart racing (P < .0001) categories.

On the other hand, ratings of anxious/nervous and paranoid categories were significantly lower in the 30-mg THC plus 15-mg D-limonene vs the 30-mg THC alone condition (P < .05, for all).

As for cognition, following drug administration, a significant main effect of treatment was observed for the DSST (P < .05), but no significant differences between THC and THC plus D-limonene combination conditions or between D-limonene alone and placebo were detected.

There were no differences within each THC dose and between D-limonene alone versus placebo conditions. Moreover, there were no main effects of treatment found for SBP or DBP.

The combination condition produced significantly greater concentrations of THC than the THC alone condition (P < .05).

“This study provides the first evidence that there are chemical constituents found naturally in the cannabis plant that can reduce some of the adverse effects of using delta-9-THC,” Dr. Vandrey said.

Although the exact mechanism by which vaporized D-limonene counters the anxiogenic effects of THC is unclear, “our best guess is that D-limonene is producing an anxiolytic effect on its own that is not mediated by cannabinoid receptors,” Dr. Vandrey said.
 

Significant Impact

Commenting on the research, Joshua Lile, PhD, professor, Department of Behavioral Science, University of Kentucky College of Medicine, Lexington, noted that the study seems to be the first of its kind to study the influence of terpene on THC response.

The research “makes a significant impact on our field,” and is “among the few controlled clinical studies that have demonstrated interactions between THC and other cannabis constituents, supporting the validity of the ‘entourage’ effect,” said Dr. Lile, who was not involved with the current research.

“This work is particularly important, given the unfounded claims sometimes made by the cannabis industry regarding the effects of different cannabis products,” he added.

Also commenting on the study, Ziva Cooper, PhD, professor and director of the UCLA Center for Cannabis and Cannabinoids, University of California Los Angeles, said the findings “have direct implications for improving the safety of cannabis, whether it’s being used for medical or nonmedical purposes, especially in people and patients who do not have experience with cannabis, a group that is at high risk for experiencing anxiety after using cannabis.”

In addition, “an important aspect to this study is that the effects of limonene in reducing anxiety attributed to delta-9-THC were observed at higher concentrations (or doses) than those usually present in the plant,” Dr. Copper said. “This calls for further investigation into new cannabis formulations specifically designed to leverage the potential protective effects of the terpene.”

This research was supported by the National Institute on Drug Abuse. Dr. Vandrey served as a consultant or received honoraria from Mira1a Therapeutics, Inc.; Jazz Pharmaceuticals; Charlotte’s Web; Syqe Medical Ltd.; and WebMD. The other authors’ disclosures are listed on the original paper. Dr. Lile declared no relevant financial relationships. Dr. Cooper reported receiving study drug from Canopy Growth Corp and True Terpenes, study-related materials from Storz & Bickel, and research support from the National Institute on Drug Abuse, National Center for Complementary and Integrative Health, California Department of Cannabis Control, Center for Medicinal Cannabis Research, and California Highway Patrol.
 

A version of this article appeared on Medscape.com.

Combining D-limonene, a naturally occurring terpene in cannabis, with delta-9-tetrahydrocannabinol (THC), the primary psychoactive component in cannabis, may mitigate THC-induced anxiety, new data from a small study suggested.

Participants who inhaled vaporized D-limonene and THC reported significantly greater decreases in anxiogenic effects than did people who received either component alone or a placebo. Reductions were greater as the dose of the D-limonene was increased.

Investigators noted that the findings could have implications for the use of medicinal or recreational cannabis, which has increased in recent years due to state legalization efforts.

“People use cannabis to help reduce anxiety, depression, and posttraumatic stress disorder, but since THC levels vary widely, if a person overshoots their tolerance of THC, cannabis can induce anxiety rather than relieve it,” senior investigator Ryan Vandrey, PhD, professor of psychiatry and behavioral sciences, Johns Hopkins School of Medicine, Baltimore, said in a news release.

“Our study demonstrates that D-limonene can modulate the effects of THC in a meaningful way and make THC more tolerable to people using it for both therapeutic and non-therapeutic purposes,” he added.

The study was published online in Drug and Alcohol Dependence.
 

Entourage Theory

Cannabis legalization has opened the door to an increased range of medicinal and nonmedicinal uses, but its benefits can be limited by the anxiety and panic some people experience with its use, investigators noted.

Many cannabis plants have been bred to contain higher concentrations of THC, with some dispensaries selling cannabis with more than 20%-30% THC. The plants often include cannabidiol, “minor” cannabinoids, and terpenes, such as D-limonene.

Prior studies pointed to THC as the cause of acute behavioral and psychoactive effects some cannabis users experience. However, a new, untested theory, the “cannabis entourage effect theory,” suggested other components in cannabis, including D-limonene, may contribute to the anxiogenic symptoms.

“We were motivated by scientific publications that hypothesized D-limonene can attenuate the acute anxiogenic effects of cannabis, but for which empirical data did not exist,” Dr. Vandrey said.

Investigators designed a small double-blind, within-subjects crossover study of 20 healthy adults (median age, 26 years; 50% men). About half of participants were Caucasian/non-Hispanic, 30% African American/non-Hispanic, 10% Caucasian/Hispanic, and 10% Asian/non-Hispanic.

All participants completed nine outpatient drug administration sessions, during which they inhaled vaporized D-limonene alone (1 or 5 mg), THC alone (15 or 30 mg), the same doses of THC and D-limonene together, or placebo.

Primary outcomes included subjective drug effects, measured with the Drug Effect Questionnaire (DEQ) and the 20-item state subscale of the State-Trait Anxiety Inventory (STAI-S). Investigators also measured cognitive/psychomotor performance with the Digit Symbol Substitution Task (DSST) and the Paced Serial Addition Task.

Vital signs such as heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), and plasma D-limonene and THC concentrations were also tracked.

Participants’ responses were measured at baseline and then an additional nine times after initial exposure over the course of each 6-hour test session. Blood and urine samples were collected from participants before, during, and after each session.
 

First Evidence

There were no significant differences in outcomes between the D-limonene alone and placebo groups.

Receipt of 15- and 30-mg doses of THC alone was associated with subjective reports of acute cannabis exposure, including cognitive and physiological effects.

A treatment effect was observed for “anxious/nervous” (P < .01), “paranoid” (P < .01), and “heart racing” (P < .0001).

In planned comparisons, ratings of anxiety-like subjective effects qualitatively decreased as D-limonene dose increased, and concurrent administration of 30-mg THC plus 15-mg D-limonene significantly reduced ratings of “anxious/nervous” and “paranoid” on the DEQ compared to 30 mg of THC alone (P < .05).

Findings were similar on the composite score of the STAI-S, and although planned comparisons did not reach the threshold for statistical significance, reductions in anxiety approached significance in the THC plus D-limonene group compared with the THC alone condition (P = .08). The combination group also reported significantly lower subjective ratings of unpleasant drug effects than the THC alone group (P = .03).

In particular, a main effect of treatment was found for the anxious/nervous category on the DEQ (P < .01), as well as the “paranoid” (P < .01) and heart racing (P < .0001) categories.

On the other hand, ratings of anxious/nervous and paranoid categories were significantly lower in the 30-mg THC plus 15-mg D-limonene vs the 30-mg THC alone condition (P < .05, for all).

As for cognition, following drug administration, a significant main effect of treatment was observed for the DSST (P < .05), but no significant differences between THC and THC plus D-limonene combination conditions or between D-limonene alone and placebo were detected.

There were no differences within each THC dose and between D-limonene alone versus placebo conditions. Moreover, there were no main effects of treatment found for SBP or DBP.

The combination condition produced significantly greater concentrations of THC than the THC alone condition (P < .05).

“This study provides the first evidence that there are chemical constituents found naturally in the cannabis plant that can reduce some of the adverse effects of using delta-9-THC,” Dr. Vandrey said.

Although the exact mechanism by which vaporized D-limonene counters the anxiogenic effects of THC is unclear, “our best guess is that D-limonene is producing an anxiolytic effect on its own that is not mediated by cannabinoid receptors,” Dr. Vandrey said.
 

Significant Impact

Commenting on the research, Joshua Lile, PhD, professor, Department of Behavioral Science, University of Kentucky College of Medicine, Lexington, noted that the study seems to be the first of its kind to study the influence of terpene on THC response.

The research “makes a significant impact on our field,” and is “among the few controlled clinical studies that have demonstrated interactions between THC and other cannabis constituents, supporting the validity of the ‘entourage’ effect,” said Dr. Lile, who was not involved with the current research.

“This work is particularly important, given the unfounded claims sometimes made by the cannabis industry regarding the effects of different cannabis products,” he added.

Also commenting on the study, Ziva Cooper, PhD, professor and director of the UCLA Center for Cannabis and Cannabinoids, University of California Los Angeles, said the findings “have direct implications for improving the safety of cannabis, whether it’s being used for medical or nonmedical purposes, especially in people and patients who do not have experience with cannabis, a group that is at high risk for experiencing anxiety after using cannabis.”

In addition, “an important aspect to this study is that the effects of limonene in reducing anxiety attributed to delta-9-THC were observed at higher concentrations (or doses) than those usually present in the plant,” Dr. Copper said. “This calls for further investigation into new cannabis formulations specifically designed to leverage the potential protective effects of the terpene.”

This research was supported by the National Institute on Drug Abuse. Dr. Vandrey served as a consultant or received honoraria from Mira1a Therapeutics, Inc.; Jazz Pharmaceuticals; Charlotte’s Web; Syqe Medical Ltd.; and WebMD. The other authors’ disclosures are listed on the original paper. Dr. Lile declared no relevant financial relationships. Dr. Cooper reported receiving study drug from Canopy Growth Corp and True Terpenes, study-related materials from Storz & Bickel, and research support from the National Institute on Drug Abuse, National Center for Complementary and Integrative Health, California Department of Cannabis Control, Center for Medicinal Cannabis Research, and California Highway Patrol.
 

A version of this article appeared on Medscape.com.

Combining D-limonene, a naturally occurring terpene in cannabis, with delta-9-tetrahydrocannabinol (THC), the primary psychoactive component in cannabis, may mitigate THC-induced anxiety, new data from a small study suggested.

Participants who inhaled vaporized D-limonene and THC reported significantly greater decreases in anxiogenic effects than did people who received either component alone or a placebo. Reductions were greater as the dose of the D-limonene was increased.

Investigators noted that the findings could have implications for the use of medicinal or recreational cannabis, which has increased in recent years due to state legalization efforts.

“People use cannabis to help reduce anxiety, depression, and posttraumatic stress disorder, but since THC levels vary widely, if a person overshoots their tolerance of THC, cannabis can induce anxiety rather than relieve it,” senior investigator Ryan Vandrey, PhD, professor of psychiatry and behavioral sciences, Johns Hopkins School of Medicine, Baltimore, said in a news release.

“Our study demonstrates that D-limonene can modulate the effects of THC in a meaningful way and make THC more tolerable to people using it for both therapeutic and non-therapeutic purposes,” he added.

The study was published online in Drug and Alcohol Dependence.
 

Entourage Theory

Cannabis legalization has opened the door to an increased range of medicinal and nonmedicinal uses, but its benefits can be limited by the anxiety and panic some people experience with its use, investigators noted.

Many cannabis plants have been bred to contain higher concentrations of THC, with some dispensaries selling cannabis with more than 20%-30% THC. The plants often include cannabidiol, “minor” cannabinoids, and terpenes, such as D-limonene.

Prior studies pointed to THC as the cause of acute behavioral and psychoactive effects some cannabis users experience. However, a new, untested theory, the “cannabis entourage effect theory,” suggested other components in cannabis, including D-limonene, may contribute to the anxiogenic symptoms.

“We were motivated by scientific publications that hypothesized D-limonene can attenuate the acute anxiogenic effects of cannabis, but for which empirical data did not exist,” Dr. Vandrey said.

Investigators designed a small double-blind, within-subjects crossover study of 20 healthy adults (median age, 26 years; 50% men). About half of participants were Caucasian/non-Hispanic, 30% African American/non-Hispanic, 10% Caucasian/Hispanic, and 10% Asian/non-Hispanic.

All participants completed nine outpatient drug administration sessions, during which they inhaled vaporized D-limonene alone (1 or 5 mg), THC alone (15 or 30 mg), the same doses of THC and D-limonene together, or placebo.

Primary outcomes included subjective drug effects, measured with the Drug Effect Questionnaire (DEQ) and the 20-item state subscale of the State-Trait Anxiety Inventory (STAI-S). Investigators also measured cognitive/psychomotor performance with the Digit Symbol Substitution Task (DSST) and the Paced Serial Addition Task.

Vital signs such as heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), and plasma D-limonene and THC concentrations were also tracked.

Participants’ responses were measured at baseline and then an additional nine times after initial exposure over the course of each 6-hour test session. Blood and urine samples were collected from participants before, during, and after each session.
 

First Evidence

There were no significant differences in outcomes between the D-limonene alone and placebo groups.

Receipt of 15- and 30-mg doses of THC alone was associated with subjective reports of acute cannabis exposure, including cognitive and physiological effects.

A treatment effect was observed for “anxious/nervous” (P < .01), “paranoid” (P < .01), and “heart racing” (P < .0001).

In planned comparisons, ratings of anxiety-like subjective effects qualitatively decreased as D-limonene dose increased, and concurrent administration of 30-mg THC plus 15-mg D-limonene significantly reduced ratings of “anxious/nervous” and “paranoid” on the DEQ compared to 30 mg of THC alone (P < .05).

Findings were similar on the composite score of the STAI-S, and although planned comparisons did not reach the threshold for statistical significance, reductions in anxiety approached significance in the THC plus D-limonene group compared with the THC alone condition (P = .08). The combination group also reported significantly lower subjective ratings of unpleasant drug effects than the THC alone group (P = .03).

In particular, a main effect of treatment was found for the anxious/nervous category on the DEQ (P < .01), as well as the “paranoid” (P < .01) and heart racing (P < .0001) categories.

On the other hand, ratings of anxious/nervous and paranoid categories were significantly lower in the 30-mg THC plus 15-mg D-limonene vs the 30-mg THC alone condition (P < .05, for all).

As for cognition, following drug administration, a significant main effect of treatment was observed for the DSST (P < .05), but no significant differences between THC and THC plus D-limonene combination conditions or between D-limonene alone and placebo were detected.

There were no differences within each THC dose and between D-limonene alone versus placebo conditions. Moreover, there were no main effects of treatment found for SBP or DBP.

The combination condition produced significantly greater concentrations of THC than the THC alone condition (P < .05).

“This study provides the first evidence that there are chemical constituents found naturally in the cannabis plant that can reduce some of the adverse effects of using delta-9-THC,” Dr. Vandrey said.

Although the exact mechanism by which vaporized D-limonene counters the anxiogenic effects of THC is unclear, “our best guess is that D-limonene is producing an anxiolytic effect on its own that is not mediated by cannabinoid receptors,” Dr. Vandrey said.
 

Significant Impact

Commenting on the research, Joshua Lile, PhD, professor, Department of Behavioral Science, University of Kentucky College of Medicine, Lexington, noted that the study seems to be the first of its kind to study the influence of terpene on THC response.

The research “makes a significant impact on our field,” and is “among the few controlled clinical studies that have demonstrated interactions between THC and other cannabis constituents, supporting the validity of the ‘entourage’ effect,” said Dr. Lile, who was not involved with the current research.

“This work is particularly important, given the unfounded claims sometimes made by the cannabis industry regarding the effects of different cannabis products,” he added.

Also commenting on the study, Ziva Cooper, PhD, professor and director of the UCLA Center for Cannabis and Cannabinoids, University of California Los Angeles, said the findings “have direct implications for improving the safety of cannabis, whether it’s being used for medical or nonmedical purposes, especially in people and patients who do not have experience with cannabis, a group that is at high risk for experiencing anxiety after using cannabis.”

In addition, “an important aspect to this study is that the effects of limonene in reducing anxiety attributed to delta-9-THC were observed at higher concentrations (or doses) than those usually present in the plant,” Dr. Copper said. “This calls for further investigation into new cannabis formulations specifically designed to leverage the potential protective effects of the terpene.”

This research was supported by the National Institute on Drug Abuse. Dr. Vandrey served as a consultant or received honoraria from Mira1a Therapeutics, Inc.; Jazz Pharmaceuticals; Charlotte’s Web; Syqe Medical Ltd.; and WebMD. The other authors’ disclosures are listed on the original paper. Dr. Lile declared no relevant financial relationships. Dr. Cooper reported receiving study drug from Canopy Growth Corp and True Terpenes, study-related materials from Storz & Bickel, and research support from the National Institute on Drug Abuse, National Center for Complementary and Integrative Health, California Department of Cannabis Control, Center for Medicinal Cannabis Research, and California Highway Patrol.
 

A version of this article appeared on Medscape.com.

Children with autism spectrum disorder (ASD) may have earlier onset of suicidal thoughts and behaviors (STB) than their typically developing peers, according to a research letter in JAMA Pediatrics.

Suicide rates among all US children ages 10-14 years tripled between 2007 and 2021, becoming the second leading cause of death for this age bracket.  Between 2018 and 2021, 315 suicides were reported among US children ages 5 to 11 years.

People with ASD show increased rates of STB, although prevalence estimates vary by study, which led the authors to study the issue.

Lead author Benjamin Joffe Schindel, MD, MPH, a fellow in neurodevelopmental medicine at the Kennedy Krieger Institute in Columbia, Maryland, and colleagues, analyzed responses from 968 caregivers of children ages 8-25 with ASD.

They found the following reported lifetime STB incidence:

• 392 (40.5%) reported wanting to die
• 187 (19.3%) reported wanting to end their own lives
• 72 (7.4%) reported having a suicide plan

Among those answering affirmatively to each of the above questions regarding STB, onset at 8 years or younger was reported in 142 (36.2%); 66 (35.3%); and 13 (18.1%) of the children, respectively. Included in the findings was one suicide attempt by cutting in an 8-year-old child.

Dr. Schindel said though there is no direct comparison with age of these thoughts among the general population, a previous study in 2013 showed that through age 10 prevalence of suicide ideation is very low (< 1%), then increases slowly through age 12 and then more rapidly until age 17.
 

Disturbing Findings

“The unexpectedly high frequency of STBs among children with ASD who were 8 years or younger is particularly disturbing given the lack of validated suicide risk screening tools and interventions for this age group,” the authors wrote. They added that early start of STB in children with ASD is important as this population has been underrepresented in suicide research and prevention efforts.

The average child age in this study was 13.4; 84.8% were White; and 81% were male. More than half of the children (54.8%) were taking medications for emotional, behavioral, or mood-related issues.

Data were collected from May to October 2017 from responses to the Mental Health and Suicidal Behaviors Questionnaire, an online caregiver-answered survey. The survey was created and distributed by the Interactive Autism Network (IAN), an international autism registry, from 2006 to 2019 with approximately 55, 000 participating families.
 

Thoughts Come at a ‘Shockingly Young Age’

Suzanne Rybczynski, MD, chief medical officer at East Tennessee Children’s Hospital in Knoxville, who was not part of the research, said the study was small but will help get the message out that “kids start thinking about suicide, especially kids with autism,” at a “shockingly young age.”

The results demonstrate the great demand for studying thoughts and behaviors especially in younger children and in children with neurodiversity — autism or other neurodevelopmental disabilities.

Studying children with ASD in relation to suicidal thoughts is difficult, Dr. Rybczynski said, because the way they think about death and how much is understood about the finality of suicide has not been well studied. It’s also uncertain how well the children understood the questions in this study, she added.

This retrospective study also asked for responses from caregivers who may remember or interpret a child’s thoughts and words differently from the child’s true intent, Dr. Rybczynski said.

“We need more studies like this asking questions to kids directly,” she said, so researchers can figure what children think it means to die.
 

Current Screening Recommendations

Current recommendations from the American Academy of Pediatrics (AAP) are to screen children universally for suicide risk at age 12 using a validated tool and if there are behavioral health concerns, screen as needed from ages 8 to 12.

This study suggests that screening needs to start earlier, Dr. Rybczynski said. “But we also need to know that we’re asking the right questions” and whether questions might be different for children with different abilities.

Children who are less verbal are often not included in screening. Screening studies often specifically exclude children with neurodisabilities, she explained. Getting these youngsters involved and making appropriate screening available “would be lifesaving,” she said.

“There are no validated (screening) tools down to age 8, which is not to say that some organizations don’t use them, but they’re not validated,” she said.

Dr. Rybczynski pointed out that most of the children were White and male and future work investigating these thoughts in girls and other racial/ethnic groups with ASD will be important as well. In addition, it will be important to revisit the issue post-pandemic with the rise in mental health issues with COVID-19.

Identifying children struggling with thoughts of suicide is the key to preventing tragedy, Dr. Rybczynski said, adding, “All those deaths are avoidable.”

Various study coauthors disclosed ties to the Simons Foundation, the Patient-Centered Outcomes Research Institute, the US Social Security Administration, American Foundation for Suicide Prevention, and Sarepta. No other disclosures were reported. Dr. Rybczynski, who provided commentary on the study, has no relevant financial relationships.

Children with autism spectrum disorder (ASD) may have earlier onset of suicidal thoughts and behaviors (STB) than their typically developing peers, according to a research letter in JAMA Pediatrics.

Suicide rates among all US children ages 10-14 years tripled between 2007 and 2021, becoming the second leading cause of death for this age bracket.  Between 2018 and 2021, 315 suicides were reported among US children ages 5 to 11 years.

People with ASD show increased rates of STB, although prevalence estimates vary by study, which led the authors to study the issue.

Lead author Benjamin Joffe Schindel, MD, MPH, a fellow in neurodevelopmental medicine at the Kennedy Krieger Institute in Columbia, Maryland, and colleagues, analyzed responses from 968 caregivers of children ages 8-25 with ASD.

They found the following reported lifetime STB incidence:

• 392 (40.5%) reported wanting to die
• 187 (19.3%) reported wanting to end their own lives
• 72 (7.4%) reported having a suicide plan

Among those answering affirmatively to each of the above questions regarding STB, onset at 8 years or younger was reported in 142 (36.2%); 66 (35.3%); and 13 (18.1%) of the children, respectively. Included in the findings was one suicide attempt by cutting in an 8-year-old child.

Dr. Schindel said though there is no direct comparison with age of these thoughts among the general population, a previous study in 2013 showed that through age 10 prevalence of suicide ideation is very low (< 1%), then increases slowly through age 12 and then more rapidly until age 17.
 

Disturbing Findings

“The unexpectedly high frequency of STBs among children with ASD who were 8 years or younger is particularly disturbing given the lack of validated suicide risk screening tools and interventions for this age group,” the authors wrote. They added that early start of STB in children with ASD is important as this population has been underrepresented in suicide research and prevention efforts.

The average child age in this study was 13.4; 84.8% were White; and 81% were male. More than half of the children (54.8%) were taking medications for emotional, behavioral, or mood-related issues.

Data were collected from May to October 2017 from responses to the Mental Health and Suicidal Behaviors Questionnaire, an online caregiver-answered survey. The survey was created and distributed by the Interactive Autism Network (IAN), an international autism registry, from 2006 to 2019 with approximately 55, 000 participating families.
 

Thoughts Come at a ‘Shockingly Young Age’

Suzanne Rybczynski, MD, chief medical officer at East Tennessee Children’s Hospital in Knoxville, who was not part of the research, said the study was small but will help get the message out that “kids start thinking about suicide, especially kids with autism,” at a “shockingly young age.”

The results demonstrate the great demand for studying thoughts and behaviors especially in younger children and in children with neurodiversity — autism or other neurodevelopmental disabilities.

Studying children with ASD in relation to suicidal thoughts is difficult, Dr. Rybczynski said, because the way they think about death and how much is understood about the finality of suicide has not been well studied. It’s also uncertain how well the children understood the questions in this study, she added.

This retrospective study also asked for responses from caregivers who may remember or interpret a child’s thoughts and words differently from the child’s true intent, Dr. Rybczynski said.

“We need more studies like this asking questions to kids directly,” she said, so researchers can figure what children think it means to die.
 

Current Screening Recommendations

Current recommendations from the American Academy of Pediatrics (AAP) are to screen children universally for suicide risk at age 12 using a validated tool and if there are behavioral health concerns, screen as needed from ages 8 to 12.

This study suggests that screening needs to start earlier, Dr. Rybczynski said. “But we also need to know that we’re asking the right questions” and whether questions might be different for children with different abilities.

Children who are less verbal are often not included in screening. Screening studies often specifically exclude children with neurodisabilities, she explained. Getting these youngsters involved and making appropriate screening available “would be lifesaving,” she said.

“There are no validated (screening) tools down to age 8, which is not to say that some organizations don’t use them, but they’re not validated,” she said.

Dr. Rybczynski pointed out that most of the children were White and male and future work investigating these thoughts in girls and other racial/ethnic groups with ASD will be important as well. In addition, it will be important to revisit the issue post-pandemic with the rise in mental health issues with COVID-19.

Identifying children struggling with thoughts of suicide is the key to preventing tragedy, Dr. Rybczynski said, adding, “All those deaths are avoidable.”

Various study coauthors disclosed ties to the Simons Foundation, the Patient-Centered Outcomes Research Institute, the US Social Security Administration, American Foundation for Suicide Prevention, and Sarepta. No other disclosures were reported. Dr. Rybczynski, who provided commentary on the study, has no relevant financial relationships.

Children with autism spectrum disorder (ASD) may have earlier onset of suicidal thoughts and behaviors (STB) than their typically developing peers, according to a research letter in JAMA Pediatrics.

Suicide rates among all US children ages 10-14 years tripled between 2007 and 2021, becoming the second leading cause of death for this age bracket.  Between 2018 and 2021, 315 suicides were reported among US children ages 5 to 11 years.

People with ASD show increased rates of STB, although prevalence estimates vary by study, which led the authors to study the issue.

Lead author Benjamin Joffe Schindel, MD, MPH, a fellow in neurodevelopmental medicine at the Kennedy Krieger Institute in Columbia, Maryland, and colleagues, analyzed responses from 968 caregivers of children ages 8-25 with ASD.

They found the following reported lifetime STB incidence:

• 392 (40.5%) reported wanting to die
• 187 (19.3%) reported wanting to end their own lives
• 72 (7.4%) reported having a suicide plan

Among those answering affirmatively to each of the above questions regarding STB, onset at 8 years or younger was reported in 142 (36.2%); 66 (35.3%); and 13 (18.1%) of the children, respectively. Included in the findings was one suicide attempt by cutting in an 8-year-old child.

Dr. Schindel said though there is no direct comparison with age of these thoughts among the general population, a previous study in 2013 showed that through age 10 prevalence of suicide ideation is very low (< 1%), then increases slowly through age 12 and then more rapidly until age 17.
 

Disturbing Findings

“The unexpectedly high frequency of STBs among children with ASD who were 8 years or younger is particularly disturbing given the lack of validated suicide risk screening tools and interventions for this age group,” the authors wrote. They added that early start of STB in children with ASD is important as this population has been underrepresented in suicide research and prevention efforts.

The average child age in this study was 13.4; 84.8% were White; and 81% were male. More than half of the children (54.8%) were taking medications for emotional, behavioral, or mood-related issues.

Data were collected from May to October 2017 from responses to the Mental Health and Suicidal Behaviors Questionnaire, an online caregiver-answered survey. The survey was created and distributed by the Interactive Autism Network (IAN), an international autism registry, from 2006 to 2019 with approximately 55, 000 participating families.
 

Thoughts Come at a ‘Shockingly Young Age’

Suzanne Rybczynski, MD, chief medical officer at East Tennessee Children’s Hospital in Knoxville, who was not part of the research, said the study was small but will help get the message out that “kids start thinking about suicide, especially kids with autism,” at a “shockingly young age.”

The results demonstrate the great demand for studying thoughts and behaviors especially in younger children and in children with neurodiversity — autism or other neurodevelopmental disabilities.

Studying children with ASD in relation to suicidal thoughts is difficult, Dr. Rybczynski said, because the way they think about death and how much is understood about the finality of suicide has not been well studied. It’s also uncertain how well the children understood the questions in this study, she added.

This retrospective study also asked for responses from caregivers who may remember or interpret a child’s thoughts and words differently from the child’s true intent, Dr. Rybczynski said.

“We need more studies like this asking questions to kids directly,” she said, so researchers can figure what children think it means to die.
 

Current Screening Recommendations

Current recommendations from the American Academy of Pediatrics (AAP) are to screen children universally for suicide risk at age 12 using a validated tool and if there are behavioral health concerns, screen as needed from ages 8 to 12.

This study suggests that screening needs to start earlier, Dr. Rybczynski said. “But we also need to know that we’re asking the right questions” and whether questions might be different for children with different abilities.

Children who are less verbal are often not included in screening. Screening studies often specifically exclude children with neurodisabilities, she explained. Getting these youngsters involved and making appropriate screening available “would be lifesaving,” she said.

“There are no validated (screening) tools down to age 8, which is not to say that some organizations don’t use them, but they’re not validated,” she said.

Dr. Rybczynski pointed out that most of the children were White and male and future work investigating these thoughts in girls and other racial/ethnic groups with ASD will be important as well. In addition, it will be important to revisit the issue post-pandemic with the rise in mental health issues with COVID-19.

Identifying children struggling with thoughts of suicide is the key to preventing tragedy, Dr. Rybczynski said, adding, “All those deaths are avoidable.”

Various study coauthors disclosed ties to the Simons Foundation, the Patient-Centered Outcomes Research Institute, the US Social Security Administration, American Foundation for Suicide Prevention, and Sarepta. No other disclosures were reported. Dr. Rybczynski, who provided commentary on the study, has no relevant financial relationships.

Psychiatry, like all medical disciplines, changes over time. For many decades, psychiatrists were primarily psychotherapists. As medications slowly became available, these became a second tool for treatment — so much so that by the 21st century many, if not most, psychiatrists saw themselves primarily as psychopharmacologists and diagnosticians who were skilled at identifying various forms of mental illness and using medications in the hopes of inducing a clinically meaningful “response” in symptoms. While still belonging to the umbrella category of a mental health professional, more and more psychiatrists trained and practiced as mental illness professionals.

Slowly, however, there have been stirrings within the field by many who have found the identity of the psychiatrist as a “prescriber” to be too narrow, and the current “med check” model of treatment too confining. This change was partly inspired by our colleagues in clinical psychology who were challenged in the 1990s by then American Psychological Association President Martin Seligman, PhD, to develop knowledge and expertise not only in alleviating mental suffering but also in promoting true mental well-being, a construct that still was often vaguely defined. One framework of well-being that was advanced at the time was the PERMA model, representing the five well-being dimensions of Positive emotions, Engagement, Relationships, Meaning, and Accomplishment.¹

Dr. Rettew

While there have always been those in psychiatry who have advocated for a broad emphasis that incorporates the full spectrum of mental health, there has been a surge of interest in the past 10-15 years, urging a focus on well-being and the tools that can help a person achieve it. This trend has variably been referred to as positive psychiatry, lifestyle psychiatry, and other terms.² As one might expect, child and adolescent psychiatry has been particularly fertile ground for such principles, and models such as the Vermont Family Based Approach have expanded the concept beyond the individual to the family and even community.³

It is important to note here that embracing the concept of well-being in treatment does not in any way require one to abandon the idea that genetic or environmental factors can lead to negative outcomes in brain development, nor does it mandate that one leaves behind important treatment modalities such as traditional psychotherapy and medication treatment. Further, this approach should not be confused with some “wellness” activities that offer quick fixes and lack scientific rigor. Positive psychiatry does, however, offer a third pathway to advance positive emotional behavioral growth, namely through health promotion activities ranging from exercise to good nutrition to positive parenting in ways that have been shown to benefit both those who are already doing fairly well as well as those who are actively struggling with significant psychiatric disorders.⁴

Primary care clinicians already have extensive familiarity talking about these kinds of health promoting activities with families. That said, it’s been my observation from many years of doing consultations and reviewing notes that these conversations happen almost exclusively during well-check visits and can get forgotten when a child presents with emotional behavioral challenges.

So how can the primary care clinician who is interested in more fully incorporating the burgeoning science on well-being work these principles into routine practice? Here are three suggestions.
 

Ask Some New Questions

It’s difficult to treat things that aren’t assessed. To best incorporate true mental health within one’s work with families, it can be very helpful to expand the regular questions one asks to include those that address some of the PERMA and health promotion areas described above. Some examples could include the following:

• Hopes. What would a perfect life look like for you when you’re older?
• Connection. Is there anything that you just love doing, so much so that time sometimes just seems to go away?
• Strengths. What are you good at? What good things would your friends say about you?
• Parenting. What are you most proud of as a parent, and where are your biggest challenges?
• Nutrition. What does a typical school day breakfast look like for you?
• Screens. Do you have any restrictions related to what you do on screens?
• Sleep. Tell me about your typical bedtime routine.

Add Some New Interventions

Counseling and medications can be powerful ways to bring improvement in a child’s life, but thinking about health promotion opens up a whole new avenue for intervention. This domain includes areas like physical activity, nutrition, sleep practices, parenting, participation in music and the arts, practicing kindness towards others, and mindfulness, among others.

For someone newly diagnosed with ADHD, for example, consider expanding your treatment plan to include not only medications but also specific guidance to exercise more, limit screen usage, practice good bedtime routines, eat a real breakfast, and reduce the helicopter parenting. Monitor these areas over time.

Another example relates to common sleep problems. Before making that melatonin recommendation, ask yourself if you understand what is happening in that child’s environment at night. Are they allowed to play video games until 2 a.m.? Are they taking naps during the day because they have nothing to do? Are they downing caffeinated drinks with dinner? Does the child get zero physical activity outside of the PE class? Maybe you still will need the melatonin, but perhaps other areas need to be addressed first.
 

Find Some New Colleagues

While it can be challenging sometimes to find anyone in mental health who sees new patients, there is value is finding out the approach and methodology that psychiatric clinicians and therapists apply in their practice. Working collaboratively with those who value a well-being orientation and who can work productively with the whole family to increase health promotion can yield benefits for a patient’s long-term physical and mental health.

The renewed interest and attention on well-being and health promotion activities that can optimize brain growth are a welcome and overdue development in mental health treatment. Pediatricians and other primary care clinicians can be a critical part of this growing initiative by gaining knowledge about youth well-being, applying this knowledge in day-to-day practice, and working collaboratively with those who share a similar perspective.
 

Dr. Rettew is a child & adolescent psychiatrist and medical director of Lane County Behavioral Health in Eugene, Oregon. He is on the psychiatry faculty at Oregon Health & Science University. You can follow him on Facebook and X @PediPsych. His latest book is Parenting Made Complicated: What Science Really Knows about the Greatest Debates of Early Childhood.

References

1. Seligman, MEP. Flourish: a visionary new understanding of happiness and well-being. New York: Simon & Schuster; 2011.

2. Jeste DV, Palmer BW. (Eds.). Positive psychiatry: a clinical handbook. Washington DC: American Psychiatric Publishing; 2015. doi: 10.1176/appi.books.9781615370818.

3. Hudziak J, Ivanova MY. The Vermont family based approach: Family based health promotion, illness prevention, and intervention. Child Adolesc Psychiatr Clin N Am. 2016 Apr;25(2):167-78. doi: 10.1016/j.chc.2015.11.002.

4. Rettew DC. Incorporating positive psychiatry with children and adolescents. Current Psychiatry. 2022 November;21(11):12-16,45. doi: 10.12788/cp.0303.

Psychiatry, like all medical disciplines, changes over time. For many decades, psychiatrists were primarily psychotherapists. As medications slowly became available, these became a second tool for treatment — so much so that by the 21st century many, if not most, psychiatrists saw themselves primarily as psychopharmacologists and diagnosticians who were skilled at identifying various forms of mental illness and using medications in the hopes of inducing a clinically meaningful “response” in symptoms. While still belonging to the umbrella category of a mental health professional, more and more psychiatrists trained and practiced as mental illness professionals.

Slowly, however, there have been stirrings within the field by many who have found the identity of the psychiatrist as a “prescriber” to be too narrow, and the current “med check” model of treatment too confining. This change was partly inspired by our colleagues in clinical psychology who were challenged in the 1990s by then American Psychological Association President Martin Seligman, PhD, to develop knowledge and expertise not only in alleviating mental suffering but also in promoting true mental well-being, a construct that still was often vaguely defined. One framework of well-being that was advanced at the time was the PERMA model, representing the five well-being dimensions of Positive emotions, Engagement, Relationships, Meaning, and Accomplishment.¹

Dr. Rettew

While there have always been those in psychiatry who have advocated for a broad emphasis that incorporates the full spectrum of mental health, there has been a surge of interest in the past 10-15 years, urging a focus on well-being and the tools that can help a person achieve it. This trend has variably been referred to as positive psychiatry, lifestyle psychiatry, and other terms.² As one might expect, child and adolescent psychiatry has been particularly fertile ground for such principles, and models such as the Vermont Family Based Approach have expanded the concept beyond the individual to the family and even community.³

It is important to note here that embracing the concept of well-being in treatment does not in any way require one to abandon the idea that genetic or environmental factors can lead to negative outcomes in brain development, nor does it mandate that one leaves behind important treatment modalities such as traditional psychotherapy and medication treatment. Further, this approach should not be confused with some “wellness” activities that offer quick fixes and lack scientific rigor. Positive psychiatry does, however, offer a third pathway to advance positive emotional behavioral growth, namely through health promotion activities ranging from exercise to good nutrition to positive parenting in ways that have been shown to benefit both those who are already doing fairly well as well as those who are actively struggling with significant psychiatric disorders.⁴

Primary care clinicians already have extensive familiarity talking about these kinds of health promoting activities with families. That said, it’s been my observation from many years of doing consultations and reviewing notes that these conversations happen almost exclusively during well-check visits and can get forgotten when a child presents with emotional behavioral challenges.

So how can the primary care clinician who is interested in more fully incorporating the burgeoning science on well-being work these principles into routine practice? Here are three suggestions.
 

Ask Some New Questions

It’s difficult to treat things that aren’t assessed. To best incorporate true mental health within one’s work with families, it can be very helpful to expand the regular questions one asks to include those that address some of the PERMA and health promotion areas described above. Some examples could include the following:

• Hopes. What would a perfect life look like for you when you’re older?
• Connection. Is there anything that you just love doing, so much so that time sometimes just seems to go away?
• Strengths. What are you good at? What good things would your friends say about you?
• Parenting. What are you most proud of as a parent, and where are your biggest challenges?
• Nutrition. What does a typical school day breakfast look like for you?
• Screens. Do you have any restrictions related to what you do on screens?
• Sleep. Tell me about your typical bedtime routine.

Add Some New Interventions

Counseling and medications can be powerful ways to bring improvement in a child’s life, but thinking about health promotion opens up a whole new avenue for intervention. This domain includes areas like physical activity, nutrition, sleep practices, parenting, participation in music and the arts, practicing kindness towards others, and mindfulness, among others.

For someone newly diagnosed with ADHD, for example, consider expanding your treatment plan to include not only medications but also specific guidance to exercise more, limit screen usage, practice good bedtime routines, eat a real breakfast, and reduce the helicopter parenting. Monitor these areas over time.

Another example relates to common sleep problems. Before making that melatonin recommendation, ask yourself if you understand what is happening in that child’s environment at night. Are they allowed to play video games until 2 a.m.? Are they taking naps during the day because they have nothing to do? Are they downing caffeinated drinks with dinner? Does the child get zero physical activity outside of the PE class? Maybe you still will need the melatonin, but perhaps other areas need to be addressed first.
 

Find Some New Colleagues

While it can be challenging sometimes to find anyone in mental health who sees new patients, there is value is finding out the approach and methodology that psychiatric clinicians and therapists apply in their practice. Working collaboratively with those who value a well-being orientation and who can work productively with the whole family to increase health promotion can yield benefits for a patient’s long-term physical and mental health.

The renewed interest and attention on well-being and health promotion activities that can optimize brain growth are a welcome and overdue development in mental health treatment. Pediatricians and other primary care clinicians can be a critical part of this growing initiative by gaining knowledge about youth well-being, applying this knowledge in day-to-day practice, and working collaboratively with those who share a similar perspective.
 

Dr. Rettew is a child & adolescent psychiatrist and medical director of Lane County Behavioral Health in Eugene, Oregon. He is on the psychiatry faculty at Oregon Health & Science University. You can follow him on Facebook and X @PediPsych. His latest book is Parenting Made Complicated: What Science Really Knows about the Greatest Debates of Early Childhood.

References

1. Seligman, MEP. Flourish: a visionary new understanding of happiness and well-being. New York: Simon & Schuster; 2011.

2. Jeste DV, Palmer BW. (Eds.). Positive psychiatry: a clinical handbook. Washington DC: American Psychiatric Publishing; 2015. doi: 10.1176/appi.books.9781615370818.

3. Hudziak J, Ivanova MY. The Vermont family based approach: Family based health promotion, illness prevention, and intervention. Child Adolesc Psychiatr Clin N Am. 2016 Apr;25(2):167-78. doi: 10.1016/j.chc.2015.11.002.

4. Rettew DC. Incorporating positive psychiatry with children and adolescents. Current Psychiatry. 2022 November;21(11):12-16,45. doi: 10.12788/cp.0303.

Psychiatry, like all medical disciplines, changes over time. For many decades, psychiatrists were primarily psychotherapists. As medications slowly became available, these became a second tool for treatment — so much so that by the 21st century many, if not most, psychiatrists saw themselves primarily as psychopharmacologists and diagnosticians who were skilled at identifying various forms of mental illness and using medications in the hopes of inducing a clinically meaningful “response” in symptoms. While still belonging to the umbrella category of a mental health professional, more and more psychiatrists trained and practiced as mental illness professionals.

Slowly, however, there have been stirrings within the field by many who have found the identity of the psychiatrist as a “prescriber” to be too narrow, and the current “med check” model of treatment too confining. This change was partly inspired by our colleagues in clinical psychology who were challenged in the 1990s by then American Psychological Association President Martin Seligman, PhD, to develop knowledge and expertise not only in alleviating mental suffering but also in promoting true mental well-being, a construct that still was often vaguely defined. One framework of well-being that was advanced at the time was the PERMA model, representing the five well-being dimensions of Positive emotions, Engagement, Relationships, Meaning, and Accomplishment.¹

Dr. Rettew

While there have always been those in psychiatry who have advocated for a broad emphasis that incorporates the full spectrum of mental health, there has been a surge of interest in the past 10-15 years, urging a focus on well-being and the tools that can help a person achieve it. This trend has variably been referred to as positive psychiatry, lifestyle psychiatry, and other terms.² As one might expect, child and adolescent psychiatry has been particularly fertile ground for such principles, and models such as the Vermont Family Based Approach have expanded the concept beyond the individual to the family and even community.³

It is important to note here that embracing the concept of well-being in treatment does not in any way require one to abandon the idea that genetic or environmental factors can lead to negative outcomes in brain development, nor does it mandate that one leaves behind important treatment modalities such as traditional psychotherapy and medication treatment. Further, this approach should not be confused with some “wellness” activities that offer quick fixes and lack scientific rigor. Positive psychiatry does, however, offer a third pathway to advance positive emotional behavioral growth, namely through health promotion activities ranging from exercise to good nutrition to positive parenting in ways that have been shown to benefit both those who are already doing fairly well as well as those who are actively struggling with significant psychiatric disorders.⁴

Primary care clinicians already have extensive familiarity talking about these kinds of health promoting activities with families. That said, it’s been my observation from many years of doing consultations and reviewing notes that these conversations happen almost exclusively during well-check visits and can get forgotten when a child presents with emotional behavioral challenges.

So how can the primary care clinician who is interested in more fully incorporating the burgeoning science on well-being work these principles into routine practice? Here are three suggestions.
 

Ask Some New Questions

It’s difficult to treat things that aren’t assessed. To best incorporate true mental health within one’s work with families, it can be very helpful to expand the regular questions one asks to include those that address some of the PERMA and health promotion areas described above. Some examples could include the following:

• Hopes. What would a perfect life look like for you when you’re older?
• Connection. Is there anything that you just love doing, so much so that time sometimes just seems to go away?
• Strengths. What are you good at? What good things would your friends say about you?
• Parenting. What are you most proud of as a parent, and where are your biggest challenges?
• Nutrition. What does a typical school day breakfast look like for you?
• Screens. Do you have any restrictions related to what you do on screens?
• Sleep. Tell me about your typical bedtime routine.

Add Some New Interventions

Counseling and medications can be powerful ways to bring improvement in a child’s life, but thinking about health promotion opens up a whole new avenue for intervention. This domain includes areas like physical activity, nutrition, sleep practices, parenting, participation in music and the arts, practicing kindness towards others, and mindfulness, among others.

For someone newly diagnosed with ADHD, for example, consider expanding your treatment plan to include not only medications but also specific guidance to exercise more, limit screen usage, practice good bedtime routines, eat a real breakfast, and reduce the helicopter parenting. Monitor these areas over time.

Another example relates to common sleep problems. Before making that melatonin recommendation, ask yourself if you understand what is happening in that child’s environment at night. Are they allowed to play video games until 2 a.m.? Are they taking naps during the day because they have nothing to do? Are they downing caffeinated drinks with dinner? Does the child get zero physical activity outside of the PE class? Maybe you still will need the melatonin, but perhaps other areas need to be addressed first.
 

Find Some New Colleagues

While it can be challenging sometimes to find anyone in mental health who sees new patients, there is value is finding out the approach and methodology that psychiatric clinicians and therapists apply in their practice. Working collaboratively with those who value a well-being orientation and who can work productively with the whole family to increase health promotion can yield benefits for a patient’s long-term physical and mental health.

The renewed interest and attention on well-being and health promotion activities that can optimize brain growth are a welcome and overdue development in mental health treatment. Pediatricians and other primary care clinicians can be a critical part of this growing initiative by gaining knowledge about youth well-being, applying this knowledge in day-to-day practice, and working collaboratively with those who share a similar perspective.
 

Dr. Rettew is a child & adolescent psychiatrist and medical director of Lane County Behavioral Health in Eugene, Oregon. He is on the psychiatry faculty at Oregon Health & Science University. You can follow him on Facebook and X @PediPsych. His latest book is Parenting Made Complicated: What Science Really Knows about the Greatest Debates of Early Childhood.

References

1. Seligman, MEP. Flourish: a visionary new understanding of happiness and well-being. New York: Simon & Schuster; 2011.

2. Jeste DV, Palmer BW. (Eds.). Positive psychiatry: a clinical handbook. Washington DC: American Psychiatric Publishing; 2015. doi: 10.1176/appi.books.9781615370818.

3. Hudziak J, Ivanova MY. The Vermont family based approach: Family based health promotion, illness prevention, and intervention. Child Adolesc Psychiatr Clin N Am. 2016 Apr;25(2):167-78. doi: 10.1016/j.chc.2015.11.002.

4. Rettew DC. Incorporating positive psychiatry with children and adolescents. Current Psychiatry. 2022 November;21(11):12-16,45. doi: 10.12788/cp.0303.

Depression is a serious issue. I want to say that off the top, because nothing below is intended to minimize it.

But does everyone need to be tested for it?

A lot of general practices test for it with every patient and every visit. After all, mandates say you have to or you’ll get penalized a few bucks. Since no one wants to leave any money on the table in the razor-thin margins of running a medical practice, they ask these questions (I don’t blame them for that).

I can see where this might be useful, but does it really do much? Or is it just a mandatory waste of time?

Good question.

A recent review by the American College of Physicians found it was mostly a waste of time (which surprises no one). Only one of the eight measures involved in depression screening (suicide risk assessment) turned out to be useful. So, basically, 88% of the time spent on these questions contributed absolutely nothing of clinical relevance.

Of course, this isn’t unique to family medicine. Every time I see a Medicare or Medicare Advantage patient I have to document whether they’ve had flu and pneumonia vaccines. While there are occasional cases where asking about recent vaccines is critical to the history, for most it’s not. But I do it so I don’t get penalized, even though the answer changes nothing. It’s not like I give vaccines in my practice.

A fair number of people come to me for hospital follow-ups, so I go into the system and review the chart. The notes inevitably contain questions of sexual activity, fear of violence, fear of domestic abuse, food security, recent travel patterns, and so on. Some of them are useful in certain situations, but not in all, or even most. All they do is increase the length of the note until anything of relevance is obscured, and allow someone in coding to check the boxes to raise the billing level. Realistically, the ER staff involved probably didn’t ask any of them, and just clicked “no.”

Once this probably seemed like a good idea, but clearly most of it is now a waste of time. These “quality measures” have turned the art of taking a good history into a session of mouse and box clicking.

Does that really improve care?
 

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

Depression is a serious issue. I want to say that off the top, because nothing below is intended to minimize it.

But does everyone need to be tested for it?

A lot of general practices test for it with every patient and every visit. After all, mandates say you have to or you’ll get penalized a few bucks. Since no one wants to leave any money on the table in the razor-thin margins of running a medical practice, they ask these questions (I don’t blame them for that).

I can see where this might be useful, but does it really do much? Or is it just a mandatory waste of time?

Good question.

A recent review by the American College of Physicians found it was mostly a waste of time (which surprises no one). Only one of the eight measures involved in depression screening (suicide risk assessment) turned out to be useful. So, basically, 88% of the time spent on these questions contributed absolutely nothing of clinical relevance.

Of course, this isn’t unique to family medicine. Every time I see a Medicare or Medicare Advantage patient I have to document whether they’ve had flu and pneumonia vaccines. While there are occasional cases where asking about recent vaccines is critical to the history, for most it’s not. But I do it so I don’t get penalized, even though the answer changes nothing. It’s not like I give vaccines in my practice.

A fair number of people come to me for hospital follow-ups, so I go into the system and review the chart. The notes inevitably contain questions of sexual activity, fear of violence, fear of domestic abuse, food security, recent travel patterns, and so on. Some of them are useful in certain situations, but not in all, or even most. All they do is increase the length of the note until anything of relevance is obscured, and allow someone in coding to check the boxes to raise the billing level. Realistically, the ER staff involved probably didn’t ask any of them, and just clicked “no.”

Once this probably seemed like a good idea, but clearly most of it is now a waste of time. These “quality measures” have turned the art of taking a good history into a session of mouse and box clicking.

Does that really improve care?
 

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

Depression is a serious issue. I want to say that off the top, because nothing below is intended to minimize it.

But does everyone need to be tested for it?

A lot of general practices test for it with every patient and every visit. After all, mandates say you have to or you’ll get penalized a few bucks. Since no one wants to leave any money on the table in the razor-thin margins of running a medical practice, they ask these questions (I don’t blame them for that).

I can see where this might be useful, but does it really do much? Or is it just a mandatory waste of time?

Good question.

A recent review by the American College of Physicians found it was mostly a waste of time (which surprises no one). Only one of the eight measures involved in depression screening (suicide risk assessment) turned out to be useful. So, basically, 88% of the time spent on these questions contributed absolutely nothing of clinical relevance.

Of course, this isn’t unique to family medicine. Every time I see a Medicare or Medicare Advantage patient I have to document whether they’ve had flu and pneumonia vaccines. While there are occasional cases where asking about recent vaccines is critical to the history, for most it’s not. But I do it so I don’t get penalized, even though the answer changes nothing. It’s not like I give vaccines in my practice.

A fair number of people come to me for hospital follow-ups, so I go into the system and review the chart. The notes inevitably contain questions of sexual activity, fear of violence, fear of domestic abuse, food security, recent travel patterns, and so on. Some of them are useful in certain situations, but not in all, or even most. All they do is increase the length of the note until anything of relevance is obscured, and allow someone in coding to check the boxes to raise the billing level. Realistically, the ER staff involved probably didn’t ask any of them, and just clicked “no.”

Once this probably seemed like a good idea, but clearly most of it is now a waste of time. These “quality measures” have turned the art of taking a good history into a session of mouse and box clicking.

Does that really improve care?
 

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

BUDAPEST, HUNGARY — Analyzing temporal changes in people’s speech could be a simple way of detecting mild cognitive impairment (MCI) to see whether there is a risk of developing dementia in the future, suggests research.

János Kálmán, MD, PhD, and colleagues at the University of Szeged in Hungary have developed an automated speech analysis approach called the Speech-Gap Test (S-GAP Test) that is unique because it focuses on the temporal changes made when someone talks. This means it does not overcomplicate matters by also assessing the phonetics and semantics of speech, Dr. Kálmán said. 

Dr. Kálmán presented his findings at the 32nd European Congress of Psychiatry. 
 

Temporal Speech Parameters

The test analyzes parameters such as how quickly someone speaks, whether they hesitate when they talk, how long the hesitation lasts, and how many silent pauses they make. This can be done with a mere 60-second sample of speech, Dr. Kálmán said, noting that other automated speech and language tools currently in development need much longer audio samples. 

“We tried different approaches and we finally ended up with the temporal speech parameters because these are not culture-dependent, not education-dependent, and could be more reliable than the semantic parts of [speech] analysis,” he explained.

The analysis of temporal speech parameters is also not language-dependent. Although the S-GAP Test was developed using audio samples from native Hungarian speakers, Dr. Kálmán and his collaborators have shown that it works just as well with samples from native English and German speakers. They now plan to validate the test further using samples from native Spanish speakers.
 

For Screening, Not Diagnosis

Currently, “the only purpose of this tool would be initial screening,” Dr. Kálmán said at the congress. It is not for diagnosis, and there is no intention to get it registered as a medical device. 

A national survey of primary care physicians conducted by Dr. Kálmán and collaborators showed that there was little time for performing standard cognitive tests during the average consultation. Thus, the original idea was that the S-GAP Test would be an aid to help primary care physicians quickly flag whether a patient might have cognitive problems that needed further assessment at a memory clinic or by more specialist neurology services. 

The goalposts have since been moved, from developing a pure telemedicine solution to a more widespread application that perhaps anyone could buy and download from the internet or using a smartphone. 

Dr. Kálmán doesn’t discount developing a more sophisticated version of the S-GAP Test in the future that combines temporal speech parameters with biomarkers for mild cognitive impairment or Alzheimer’s disease and could be used in memory clinics and by neurologists for the purpose of diagnosis.
 

Detect to Prevent?

The big question is: What happens to all the people that could be flagged as needing further assessment using tools such as the S-GAP Test? 

Tackling risk factors for dementia will probably be key, said Robert Perneckzy, MD, MBA, professor of translational dementia research at Ludwig Maximilian University of Munich, Imperial College London, and the University of Sheffield.

According to the Lancet Commission on dementia, there are 12 potentially modifiable risk factors for dementia. Their influence varies throughout the life course, but certain early events, such as the level of education attained, can’t be modified in an older patient. 

That said, there are many risk factors that might still be influenced later in life, such as adequately treating comorbid conditions such as diabetes, and addressing alcohol consumption and smoking practices. 

“We can do things in terms of personal risk, risk mitigation, which have a huge effect on dementia risk much later in life,” said Dr. Perneckzy.

“The speech-based assessments are another opportunity to save our time as doctors to do assessments before someone comes to the memory clinic,” he said.

The S-GAP Test is under development by the University of Szeged. Dr. Kálmán is a co-inventor. Dr. Perneckzy had no relevant conflicts of interest but has helped validate the S-GAP Test in the German language. 

A version of this article appeared on Medscape.com.

BUDAPEST, HUNGARY — Analyzing temporal changes in people’s speech could be a simple way of detecting mild cognitive impairment (MCI) to see whether there is a risk of developing dementia in the future, suggests research.

János Kálmán, MD, PhD, and colleagues at the University of Szeged in Hungary have developed an automated speech analysis approach called the Speech-Gap Test (S-GAP Test) that is unique because it focuses on the temporal changes made when someone talks. This means it does not overcomplicate matters by also assessing the phonetics and semantics of speech, Dr. Kálmán said. 

Dr. Kálmán presented his findings at the 32nd European Congress of Psychiatry. 
 

Temporal Speech Parameters

The test analyzes parameters such as how quickly someone speaks, whether they hesitate when they talk, how long the hesitation lasts, and how many silent pauses they make. This can be done with a mere 60-second sample of speech, Dr. Kálmán said, noting that other automated speech and language tools currently in development need much longer audio samples. 

“We tried different approaches and we finally ended up with the temporal speech parameters because these are not culture-dependent, not education-dependent, and could be more reliable than the semantic parts of [speech] analysis,” he explained.

The analysis of temporal speech parameters is also not language-dependent. Although the S-GAP Test was developed using audio samples from native Hungarian speakers, Dr. Kálmán and his collaborators have shown that it works just as well with samples from native English and German speakers. They now plan to validate the test further using samples from native Spanish speakers.
 

For Screening, Not Diagnosis

Currently, “the only purpose of this tool would be initial screening,” Dr. Kálmán said at the congress. It is not for diagnosis, and there is no intention to get it registered as a medical device. 

A national survey of primary care physicians conducted by Dr. Kálmán and collaborators showed that there was little time for performing standard cognitive tests during the average consultation. Thus, the original idea was that the S-GAP Test would be an aid to help primary care physicians quickly flag whether a patient might have cognitive problems that needed further assessment at a memory clinic or by more specialist neurology services. 

The goalposts have since been moved, from developing a pure telemedicine solution to a more widespread application that perhaps anyone could buy and download from the internet or using a smartphone. 

Dr. Kálmán doesn’t discount developing a more sophisticated version of the S-GAP Test in the future that combines temporal speech parameters with biomarkers for mild cognitive impairment or Alzheimer’s disease and could be used in memory clinics and by neurologists for the purpose of diagnosis.
 

Detect to Prevent?

The big question is: What happens to all the people that could be flagged as needing further assessment using tools such as the S-GAP Test? 

Tackling risk factors for dementia will probably be key, said Robert Perneckzy, MD, MBA, professor of translational dementia research at Ludwig Maximilian University of Munich, Imperial College London, and the University of Sheffield.

According to the Lancet Commission on dementia, there are 12 potentially modifiable risk factors for dementia. Their influence varies throughout the life course, but certain early events, such as the level of education attained, can’t be modified in an older patient. 

That said, there are many risk factors that might still be influenced later in life, such as adequately treating comorbid conditions such as diabetes, and addressing alcohol consumption and smoking practices. 

“We can do things in terms of personal risk, risk mitigation, which have a huge effect on dementia risk much later in life,” said Dr. Perneckzy.

“The speech-based assessments are another opportunity to save our time as doctors to do assessments before someone comes to the memory clinic,” he said.

The S-GAP Test is under development by the University of Szeged. Dr. Kálmán is a co-inventor. Dr. Perneckzy had no relevant conflicts of interest but has helped validate the S-GAP Test in the German language. 

A version of this article appeared on Medscape.com.

BUDAPEST, HUNGARY — Analyzing temporal changes in people’s speech could be a simple way of detecting mild cognitive impairment (MCI) to see whether there is a risk of developing dementia in the future, suggests research.

János Kálmán, MD, PhD, and colleagues at the University of Szeged in Hungary have developed an automated speech analysis approach called the Speech-Gap Test (S-GAP Test) that is unique because it focuses on the temporal changes made when someone talks. This means it does not overcomplicate matters by also assessing the phonetics and semantics of speech, Dr. Kálmán said. 

Dr. Kálmán presented his findings at the 32nd European Congress of Psychiatry. 
 

Temporal Speech Parameters

The test analyzes parameters such as how quickly someone speaks, whether they hesitate when they talk, how long the hesitation lasts, and how many silent pauses they make. This can be done with a mere 60-second sample of speech, Dr. Kálmán said, noting that other automated speech and language tools currently in development need much longer audio samples. 

“We tried different approaches and we finally ended up with the temporal speech parameters because these are not culture-dependent, not education-dependent, and could be more reliable than the semantic parts of [speech] analysis,” he explained.

The analysis of temporal speech parameters is also not language-dependent. Although the S-GAP Test was developed using audio samples from native Hungarian speakers, Dr. Kálmán and his collaborators have shown that it works just as well with samples from native English and German speakers. They now plan to validate the test further using samples from native Spanish speakers.
 

For Screening, Not Diagnosis

Currently, “the only purpose of this tool would be initial screening,” Dr. Kálmán said at the congress. It is not for diagnosis, and there is no intention to get it registered as a medical device. 

A national survey of primary care physicians conducted by Dr. Kálmán and collaborators showed that there was little time for performing standard cognitive tests during the average consultation. Thus, the original idea was that the S-GAP Test would be an aid to help primary care physicians quickly flag whether a patient might have cognitive problems that needed further assessment at a memory clinic or by more specialist neurology services. 

The goalposts have since been moved, from developing a pure telemedicine solution to a more widespread application that perhaps anyone could buy and download from the internet or using a smartphone. 

Dr. Kálmán doesn’t discount developing a more sophisticated version of the S-GAP Test in the future that combines temporal speech parameters with biomarkers for mild cognitive impairment or Alzheimer’s disease and could be used in memory clinics and by neurologists for the purpose of diagnosis.
 

Detect to Prevent?

The big question is: What happens to all the people that could be flagged as needing further assessment using tools such as the S-GAP Test? 

Tackling risk factors for dementia will probably be key, said Robert Perneckzy, MD, MBA, professor of translational dementia research at Ludwig Maximilian University of Munich, Imperial College London, and the University of Sheffield.

According to the Lancet Commission on dementia, there are 12 potentially modifiable risk factors for dementia. Their influence varies throughout the life course, but certain early events, such as the level of education attained, can’t be modified in an older patient. 

That said, there are many risk factors that might still be influenced later in life, such as adequately treating comorbid conditions such as diabetes, and addressing alcohol consumption and smoking practices. 

“We can do things in terms of personal risk, risk mitigation, which have a huge effect on dementia risk much later in life,” said Dr. Perneckzy.

“The speech-based assessments are another opportunity to save our time as doctors to do assessments before someone comes to the memory clinic,” he said.

The S-GAP Test is under development by the University of Szeged. Dr. Kálmán is a co-inventor. Dr. Perneckzy had no relevant conflicts of interest but has helped validate the S-GAP Test in the German language. 

A version of this article appeared on Medscape.com.

The appeal of working from home is undeniable. It comes with no daily commute, casual dress, and the ability to manage work-life balance more effectively.

Telemedicine is often the first thing that comes to mind when physicians think about remote medical practice. In its traditional sense, telemedicine entails live video consults, replicating the in-person experience as closely as possible, minus the hands-on component. However, this format is just one of many types of virtual care presenting opportunities to practice medicine from home.

The scope and volume of such opportunities are expanding due to technology, regulatory shifts at the state and federal levels favoring remote healthcare, and a wider move toward remote work. Virtual practice options for physicians range from full-time employment to flexible part-time positions that can be used to earn supplementary income.

Just a few of those virtual options are:

Remote Patient Monitoring

Remote patient monitoring uses technology for tracking patient health data, applicable in real-time or asynchronously, through devices ranging from specialized monitors to consumer wearables. Data are securely transmitted to healthcare providers, enabling them to guide or make treatment choices remotely. This method has proven particularly valuable in managing chronic diseases where continuous monitoring can significantly affect outcomes.

Like standard telemedicine, remote patient monitoring offers flexibility, autonomy, and the ability to work from home. It is picking up steam across the healthcare industry, especially in critical care, surgery, post-acute care, and primary care, so there are opportunities for physicians across a variety of specialties.

Online Medication Management and Text-Based Consults

Gathering necessary information for patient care decisions often doesn’t require a direct, face-to-face visit in person or by telemedicine. Clinical data can be efficiently collected through online forms, HIPAA-compliant messaging, medical record reviews, and information gathered by staff.

An approach that uses all these sources enables effective medication management for stable chronic conditions (such as hypertension), as well as straightforward but simple acute issues (such as urinary tract infections). It also is useful for quick follow-ups with patients after starting new treatments, to address questions between visits, and to give them educational material.

Some medical practices and virtual healthcare corporations have made online medication management and text-based consults the center of their business model. Part-time positions with platforms that offer this type of care let physicians fit consultations into their schedule as time permits, without committing to scheduled appointments.

eConsults

Electronic consultations, or eConsults, facilitate collaboration among healthcare professionals about complex cases without direct patient interaction.

These services operate via online platforms that support asynchronous communication and often bypass the need for a traditional referral. Typically, a primary care provider submits a query that is then assigned to a specialist. Next, the specialist reviews the information and offers recommendations for the patient’s care plan.

Major eConsult platforms such as AristaMD and RubiconMD contract with healthcare systems and medical practices. Physicians can easily join the specialist panels of these companies and complete assigned consultations from their homes or offices, paid on a per-consult basis. They should check their employment contracts to make sure such independent contract work is allowed.

Phone-Only On-Call Positions

On-call rotations for after-hour care bring with them challenges in staffing and scheduling vacations. These challenges have helped trigger as-needed or per diem on-call roles, in which a physician provides recommendations and orders over the phone without needing to visit an office or a hospital.

Examples of workplaces that employ phone-only on-call physicians include smaller jails, mental health facilities, dialysis centers, long-term care facilities, and sporting groups or events needing back-up for on-site nurses or emergency medical technicians.

While these positions can sometimes be challenging for a physician to find, they are out there. They can be a fantastic option to earn additional income through low-stress clinical work performed from home.

Supervision of Nurse Practitioners (NPs) and Physician Assistants (PAs)

In states that mandate such physician oversight, it often be conducted remotely — depending on that state’s rules, the practice type, and the scope of services being provided. This remote option introduces part-time opportunities for physicians to oversee NPs and PAs without being in the medical office. Essentially, the doctor needs to be available for phone or email consultations, complete chart reviews, and meet regularly with the provider.

Remote supervision roles are available across various types of healthcare organizations and medical practices. There also are opportunities with insurers, many of which have established NP-run, in-home member assessment programs that require remote supervision by a doctor.

Remote Medical Directorships

Medical directors are a key part of the clinician team in a wide variety of healthcare settings requiring clinical protocol oversight, regulatory compliance, and guidance for other clinicians making treatment decisions. Many directorships do not require direct patient contact and therefore are conducive to remote work, given technologies such as electronic health record and secure messaging systems.

Organizations such as emergency medical service agencies, hospice services, med spas, blood and plasma donation centers, home health agencies, and substance use disorder treatment programs increasingly rely on remote medical directorships to meet legal requirements and accreditation standards.

Although these positions are often viewed as “nonclinical,” they carry significant clinical responsibilities. Examples are developing and reviewing treatment protocols, ensuring adherence to healthcare regulations, and sometimes intervening in complex patient cases or when adverse outcomes occur.

Keeping a Role in Patient Welfare

Clearly, working from home as a physician doesn’t have to mean taking on a nonclinical job. Beyond the options already mentioned, there are numerous others — for example, working as a medical monitor for clinical trials, in utilization management for insurance companies, or in conducting independent medical exams for insurance claims. While these roles don’t involve direct patient treatment, they require similar skills and affect the quality of care.

If such remote opportunities aren’t currently available in your workplace, consider approaching your management about trying them. You can make an effective argument that remote practice alternatives bring value to the organization through expanded patient care capabilities and potential cost savings.

Physicians who are experiencing burnout, seeking a career change, or interested in earning extra income should consider exploring more of the unconventional ways that they can practice medicine.

A version of this article appeared on Medscape.com.

The appeal of working from home is undeniable. It comes with no daily commute, casual dress, and the ability to manage work-life balance more effectively.

Telemedicine is often the first thing that comes to mind when physicians think about remote medical practice. In its traditional sense, telemedicine entails live video consults, replicating the in-person experience as closely as possible, minus the hands-on component. However, this format is just one of many types of virtual care presenting opportunities to practice medicine from home.

The scope and volume of such opportunities are expanding due to technology, regulatory shifts at the state and federal levels favoring remote healthcare, and a wider move toward remote work. Virtual practice options for physicians range from full-time employment to flexible part-time positions that can be used to earn supplementary income.

Just a few of those virtual options are:

Remote Patient Monitoring

Remote patient monitoring uses technology for tracking patient health data, applicable in real-time or asynchronously, through devices ranging from specialized monitors to consumer wearables. Data are securely transmitted to healthcare providers, enabling them to guide or make treatment choices remotely. This method has proven particularly valuable in managing chronic diseases where continuous monitoring can significantly affect outcomes.

Like standard telemedicine, remote patient monitoring offers flexibility, autonomy, and the ability to work from home. It is picking up steam across the healthcare industry, especially in critical care, surgery, post-acute care, and primary care, so there are opportunities for physicians across a variety of specialties.

Online Medication Management and Text-Based Consults

Gathering necessary information for patient care decisions often doesn’t require a direct, face-to-face visit in person or by telemedicine. Clinical data can be efficiently collected through online forms, HIPAA-compliant messaging, medical record reviews, and information gathered by staff.

An approach that uses all these sources enables effective medication management for stable chronic conditions (such as hypertension), as well as straightforward but simple acute issues (such as urinary tract infections). It also is useful for quick follow-ups with patients after starting new treatments, to address questions between visits, and to give them educational material.

Some medical practices and virtual healthcare corporations have made online medication management and text-based consults the center of their business model. Part-time positions with platforms that offer this type of care let physicians fit consultations into their schedule as time permits, without committing to scheduled appointments.

eConsults

Electronic consultations, or eConsults, facilitate collaboration among healthcare professionals about complex cases without direct patient interaction.

These services operate via online platforms that support asynchronous communication and often bypass the need for a traditional referral. Typically, a primary care provider submits a query that is then assigned to a specialist. Next, the specialist reviews the information and offers recommendations for the patient’s care plan.

Major eConsult platforms such as AristaMD and RubiconMD contract with healthcare systems and medical practices. Physicians can easily join the specialist panels of these companies and complete assigned consultations from their homes or offices, paid on a per-consult basis. They should check their employment contracts to make sure such independent contract work is allowed.

Phone-Only On-Call Positions

On-call rotations for after-hour care bring with them challenges in staffing and scheduling vacations. These challenges have helped trigger as-needed or per diem on-call roles, in which a physician provides recommendations and orders over the phone without needing to visit an office or a hospital.

Examples of workplaces that employ phone-only on-call physicians include smaller jails, mental health facilities, dialysis centers, long-term care facilities, and sporting groups or events needing back-up for on-site nurses or emergency medical technicians.

While these positions can sometimes be challenging for a physician to find, they are out there. They can be a fantastic option to earn additional income through low-stress clinical work performed from home.

Supervision of Nurse Practitioners (NPs) and Physician Assistants (PAs)

In states that mandate such physician oversight, it often be conducted remotely — depending on that state’s rules, the practice type, and the scope of services being provided. This remote option introduces part-time opportunities for physicians to oversee NPs and PAs without being in the medical office. Essentially, the doctor needs to be available for phone or email consultations, complete chart reviews, and meet regularly with the provider.

Remote supervision roles are available across various types of healthcare organizations and medical practices. There also are opportunities with insurers, many of which have established NP-run, in-home member assessment programs that require remote supervision by a doctor.

Remote Medical Directorships

Medical directors are a key part of the clinician team in a wide variety of healthcare settings requiring clinical protocol oversight, regulatory compliance, and guidance for other clinicians making treatment decisions. Many directorships do not require direct patient contact and therefore are conducive to remote work, given technologies such as electronic health record and secure messaging systems.

Organizations such as emergency medical service agencies, hospice services, med spas, blood and plasma donation centers, home health agencies, and substance use disorder treatment programs increasingly rely on remote medical directorships to meet legal requirements and accreditation standards.

Although these positions are often viewed as “nonclinical,” they carry significant clinical responsibilities. Examples are developing and reviewing treatment protocols, ensuring adherence to healthcare regulations, and sometimes intervening in complex patient cases or when adverse outcomes occur.

Keeping a Role in Patient Welfare

Clearly, working from home as a physician doesn’t have to mean taking on a nonclinical job. Beyond the options already mentioned, there are numerous others — for example, working as a medical monitor for clinical trials, in utilization management for insurance companies, or in conducting independent medical exams for insurance claims. While these roles don’t involve direct patient treatment, they require similar skills and affect the quality of care.

If such remote opportunities aren’t currently available in your workplace, consider approaching your management about trying them. You can make an effective argument that remote practice alternatives bring value to the organization through expanded patient care capabilities and potential cost savings.

Physicians who are experiencing burnout, seeking a career change, or interested in earning extra income should consider exploring more of the unconventional ways that they can practice medicine.

A version of this article appeared on Medscape.com.

The appeal of working from home is undeniable. It comes with no daily commute, casual dress, and the ability to manage work-life balance more effectively.

Telemedicine is often the first thing that comes to mind when physicians think about remote medical practice. In its traditional sense, telemedicine entails live video consults, replicating the in-person experience as closely as possible, minus the hands-on component. However, this format is just one of many types of virtual care presenting opportunities to practice medicine from home.

The scope and volume of such opportunities are expanding due to technology, regulatory shifts at the state and federal levels favoring remote healthcare, and a wider move toward remote work. Virtual practice options for physicians range from full-time employment to flexible part-time positions that can be used to earn supplementary income.

Just a few of those virtual options are:

Remote Patient Monitoring

Remote patient monitoring uses technology for tracking patient health data, applicable in real-time or asynchronously, through devices ranging from specialized monitors to consumer wearables. Data are securely transmitted to healthcare providers, enabling them to guide or make treatment choices remotely. This method has proven particularly valuable in managing chronic diseases where continuous monitoring can significantly affect outcomes.

Like standard telemedicine, remote patient monitoring offers flexibility, autonomy, and the ability to work from home. It is picking up steam across the healthcare industry, especially in critical care, surgery, post-acute care, and primary care, so there are opportunities for physicians across a variety of specialties.

Online Medication Management and Text-Based Consults

Gathering necessary information for patient care decisions often doesn’t require a direct, face-to-face visit in person or by telemedicine. Clinical data can be efficiently collected through online forms, HIPAA-compliant messaging, medical record reviews, and information gathered by staff.

An approach that uses all these sources enables effective medication management for stable chronic conditions (such as hypertension), as well as straightforward but simple acute issues (such as urinary tract infections). It also is useful for quick follow-ups with patients after starting new treatments, to address questions between visits, and to give them educational material.

Some medical practices and virtual healthcare corporations have made online medication management and text-based consults the center of their business model. Part-time positions with platforms that offer this type of care let physicians fit consultations into their schedule as time permits, without committing to scheduled appointments.

eConsults

Electronic consultations, or eConsults, facilitate collaboration among healthcare professionals about complex cases without direct patient interaction.

These services operate via online platforms that support asynchronous communication and often bypass the need for a traditional referral. Typically, a primary care provider submits a query that is then assigned to a specialist. Next, the specialist reviews the information and offers recommendations for the patient’s care plan.

Major eConsult platforms such as AristaMD and RubiconMD contract with healthcare systems and medical practices. Physicians can easily join the specialist panels of these companies and complete assigned consultations from their homes or offices, paid on a per-consult basis. They should check their employment contracts to make sure such independent contract work is allowed.

Phone-Only On-Call Positions

On-call rotations for after-hour care bring with them challenges in staffing and scheduling vacations. These challenges have helped trigger as-needed or per diem on-call roles, in which a physician provides recommendations and orders over the phone without needing to visit an office or a hospital.

Examples of workplaces that employ phone-only on-call physicians include smaller jails, mental health facilities, dialysis centers, long-term care facilities, and sporting groups or events needing back-up for on-site nurses or emergency medical technicians.

While these positions can sometimes be challenging for a physician to find, they are out there. They can be a fantastic option to earn additional income through low-stress clinical work performed from home.

Supervision of Nurse Practitioners (NPs) and Physician Assistants (PAs)

In states that mandate such physician oversight, it often be conducted remotely — depending on that state’s rules, the practice type, and the scope of services being provided. This remote option introduces part-time opportunities for physicians to oversee NPs and PAs without being in the medical office. Essentially, the doctor needs to be available for phone or email consultations, complete chart reviews, and meet regularly with the provider.

Remote supervision roles are available across various types of healthcare organizations and medical practices. There also are opportunities with insurers, many of which have established NP-run, in-home member assessment programs that require remote supervision by a doctor.

Remote Medical Directorships

Medical directors are a key part of the clinician team in a wide variety of healthcare settings requiring clinical protocol oversight, regulatory compliance, and guidance for other clinicians making treatment decisions. Many directorships do not require direct patient contact and therefore are conducive to remote work, given technologies such as electronic health record and secure messaging systems.

Organizations such as emergency medical service agencies, hospice services, med spas, blood and plasma donation centers, home health agencies, and substance use disorder treatment programs increasingly rely on remote medical directorships to meet legal requirements and accreditation standards.

Although these positions are often viewed as “nonclinical,” they carry significant clinical responsibilities. Examples are developing and reviewing treatment protocols, ensuring adherence to healthcare regulations, and sometimes intervening in complex patient cases or when adverse outcomes occur.

Keeping a Role in Patient Welfare

Clearly, working from home as a physician doesn’t have to mean taking on a nonclinical job. Beyond the options already mentioned, there are numerous others — for example, working as a medical monitor for clinical trials, in utilization management for insurance companies, or in conducting independent medical exams for insurance claims. While these roles don’t involve direct patient treatment, they require similar skills and affect the quality of care.

If such remote opportunities aren’t currently available in your workplace, consider approaching your management about trying them. You can make an effective argument that remote practice alternatives bring value to the organization through expanded patient care capabilities and potential cost savings.

Physicians who are experiencing burnout, seeking a career change, or interested in earning extra income should consider exploring more of the unconventional ways that they can practice medicine.

A version of this article appeared on Medscape.com.

BUDAPEST, HUNGARY — Twice daily intranasal oxytocin has been associated with improved social functioning, quality of life, and overall symptoms in adults with autism spectrum disorder (ASD), results of a small randomized control trial showed.

“One of the challenges for adults with autism is experiencing poor social interactions and difficulties in making friends. Insufficient social support from peers, friends, and family members can contribute to loneliness in adolescents with ASD, which in turn leads to anxiety, sadness, and social isolation,” said study investigator Saba Faraji Niri, MD, assistant professor of psychiatry, Tehran University of Medical Sciences in Iran. 

Recent US data show it is relatively common. In addition, previous research suggests intranasal oxytocin significantly increases activity in brain regions that play a role in establishing social interactions.

To evaluate the therapeutic effects and safety of intranasal oxytocin the researchers randomly assigned 39 adult patients with ASD to receive intranasal oxytocin or placebo with 24 units administered every 12 hours for 8 weeks. 

Dr. Faraji Niri said study participants were required to stop all psychotropic medications for at least 8 weeks prior to study entry. 

Participants were assessed at baseline and weeks 4 and 8 using the Autism Quotient, Ritvo Autism Asperger Diagnostic Scale — Revised (RAADS-R), Social Responsiveness Scale (SRS), Clinical Global Impression (CGI) scale, and the World Health Organization Quality of Life-BREF (WHOQL-BREF) questionnaire. Adverse events were also evaluated.

Dr. Faraji Niri said that those receiving intranasal oxytocin showed clinical improvement on RAADS-R scores (P = .010), as well as on the social communication subscale of the SRS (P = .002), the CGI scale (P = .000), and the physical (P = .004), psychological (P = .006), and social relationships (P = .046) domains of the WHOQL-BREF. 

However, although the findings were positive, she said at this point it’s not possible to draw any definitive conclusions. She noted the study had several potential confounders. These included differences in baseline levels of endogenous oxytocin among study participants individuals, as well as difference in required treatment doses, which were adjusted by age and sex. The presence of comorbidities and interactions with other treatments could also affect the results.

Commenting on the findings for this news organization, session chair Szabolcs Kéri, PhD, Professor, Sztárai Institute, University of Tokaj, Sárospatak, Hungary, said the use of oxytocin for ASD is controversial. He said that, while the research contributes to the scientific debate, the clinical significance of the findings is unclear. 

The investigators and Dr Keri reported no relevant financial disclosures.

A version of this article appeared on Medscape.com .

BUDAPEST, HUNGARY — Twice daily intranasal oxytocin has been associated with improved social functioning, quality of life, and overall symptoms in adults with autism spectrum disorder (ASD), results of a small randomized control trial showed.

“One of the challenges for adults with autism is experiencing poor social interactions and difficulties in making friends. Insufficient social support from peers, friends, and family members can contribute to loneliness in adolescents with ASD, which in turn leads to anxiety, sadness, and social isolation,” said study investigator Saba Faraji Niri, MD, assistant professor of psychiatry, Tehran University of Medical Sciences in Iran. 

Recent US data show it is relatively common. In addition, previous research suggests intranasal oxytocin significantly increases activity in brain regions that play a role in establishing social interactions.

To evaluate the therapeutic effects and safety of intranasal oxytocin the researchers randomly assigned 39 adult patients with ASD to receive intranasal oxytocin or placebo with 24 units administered every 12 hours for 8 weeks. 

Dr. Faraji Niri said study participants were required to stop all psychotropic medications for at least 8 weeks prior to study entry. 

Participants were assessed at baseline and weeks 4 and 8 using the Autism Quotient, Ritvo Autism Asperger Diagnostic Scale — Revised (RAADS-R), Social Responsiveness Scale (SRS), Clinical Global Impression (CGI) scale, and the World Health Organization Quality of Life-BREF (WHOQL-BREF) questionnaire. Adverse events were also evaluated.

Dr. Faraji Niri said that those receiving intranasal oxytocin showed clinical improvement on RAADS-R scores (P = .010), as well as on the social communication subscale of the SRS (P = .002), the CGI scale (P = .000), and the physical (P = .004), psychological (P = .006), and social relationships (P = .046) domains of the WHOQL-BREF. 

However, although the findings were positive, she said at this point it’s not possible to draw any definitive conclusions. She noted the study had several potential confounders. These included differences in baseline levels of endogenous oxytocin among study participants individuals, as well as difference in required treatment doses, which were adjusted by age and sex. The presence of comorbidities and interactions with other treatments could also affect the results.

Commenting on the findings for this news organization, session chair Szabolcs Kéri, PhD, Professor, Sztárai Institute, University of Tokaj, Sárospatak, Hungary, said the use of oxytocin for ASD is controversial. He said that, while the research contributes to the scientific debate, the clinical significance of the findings is unclear. 

The investigators and Dr Keri reported no relevant financial disclosures.

A version of this article appeared on Medscape.com .

BUDAPEST, HUNGARY — Twice daily intranasal oxytocin has been associated with improved social functioning, quality of life, and overall symptoms in adults with autism spectrum disorder (ASD), results of a small randomized control trial showed.

“One of the challenges for adults with autism is experiencing poor social interactions and difficulties in making friends. Insufficient social support from peers, friends, and family members can contribute to loneliness in adolescents with ASD, which in turn leads to anxiety, sadness, and social isolation,” said study investigator Saba Faraji Niri, MD, assistant professor of psychiatry, Tehran University of Medical Sciences in Iran. 

Recent US data show it is relatively common. In addition, previous research suggests intranasal oxytocin significantly increases activity in brain regions that play a role in establishing social interactions.

To evaluate the therapeutic effects and safety of intranasal oxytocin the researchers randomly assigned 39 adult patients with ASD to receive intranasal oxytocin or placebo with 24 units administered every 12 hours for 8 weeks. 

Dr. Faraji Niri said study participants were required to stop all psychotropic medications for at least 8 weeks prior to study entry. 

Participants were assessed at baseline and weeks 4 and 8 using the Autism Quotient, Ritvo Autism Asperger Diagnostic Scale — Revised (RAADS-R), Social Responsiveness Scale (SRS), Clinical Global Impression (CGI) scale, and the World Health Organization Quality of Life-BREF (WHOQL-BREF) questionnaire. Adverse events were also evaluated.

Dr. Faraji Niri said that those receiving intranasal oxytocin showed clinical improvement on RAADS-R scores (P = .010), as well as on the social communication subscale of the SRS (P = .002), the CGI scale (P = .000), and the physical (P = .004), psychological (P = .006), and social relationships (P = .046) domains of the WHOQL-BREF. 

However, although the findings were positive, she said at this point it’s not possible to draw any definitive conclusions. She noted the study had several potential confounders. These included differences in baseline levels of endogenous oxytocin among study participants individuals, as well as difference in required treatment doses, which were adjusted by age and sex. The presence of comorbidities and interactions with other treatments could also affect the results.

Commenting on the findings for this news organization, session chair Szabolcs Kéri, PhD, Professor, Sztárai Institute, University of Tokaj, Sárospatak, Hungary, said the use of oxytocin for ASD is controversial. He said that, while the research contributes to the scientific debate, the clinical significance of the findings is unclear. 

The investigators and Dr Keri reported no relevant financial disclosures.

A version of this article appeared on Medscape.com .