Clinical Psychiatry News

VIENNA – The investigational agent xanomeline-trospium (KarXT, Karuna Therapeutics) achieves significant and clinically meaningful improvements in schizophrenia symptom scores without causing problematic adverse effects, new research suggests.

Results from the phase 3 EMERGENT-2 trial, which included more than 250 patients with schizophrenia, showed that those who received xanomeline-trospium for 5 weeks achieved a significant reduction in Positive and Negative Syndrome Scale (PANSS) total scores of more than nine points compared with their peers who received placebo. In addition, the improvements started at week 2.

Alongside significant reductions in both positive and negative symptoms, the results suggest the agent was well tolerated, with treatment-emergent adverse events (TEAEs) largely mild to moderate and transient in nature.

Lead investigator Christoph U. Correll, MD, professor of psychiatry at the Zucker School of Medicine at Hofstra/Northwell, Uniondale, New York, told this news organization that the upcoming EMERGENT-3 study will have a “European component” and that the “readout is expected most likely in the first quarter of next year.”

Dr. Correll suggested that if leads to “two positive studies and reasonable safety,” the novel agent may become part of the “next generation of antipsychotics that are not related to postsynaptic dopamine blockade.”

The findings for EMERGENT-2, presented at the 35th European College of Neuropsychopharmacology (ECNP) Congress as a poster and as an oral presentation, were an update of topline results released earlier this year.
 

Novel compound

Xanomeline-trospium is a novel compound that combines the dual M1/M4-preferring muscarinic receptor agonist effect of xanomeline with the peripherally restricted muscarinic receptor antagonist effect of trospium.

A previous phase 2 trial that compared the drug with placebo in almost 200 patients suggested it significantly reduced psychosis symptoms, leading to the current phase 3 trial.

Dr. Correll noted that xanomeline-trospium reduces psychosis via a “bottom up and top down approach.”

He said that on one hand, M4 agonism decreases acetylcholine in the ventral tegmental area and the associated stratum, “which then decreases dopamine levels from the bottom up,” while the M1 agonism stimulates GABA and decreases dopamine from the “top down.”

M1 agonism, however, also stimulates the cholinergic system peripherally, “which can give you nausea, vomiting, and also some blood pressure and pulse” problems, Dr. Correll said.

That was the limitation when this approach was studied by Lilly as a treatment for patients with Alzheimer’s disease, but the addition of trospium means “you’re buffering somewhat the cholinergic peripheral effects,” he said.

While that can conversely lead to dyspepsia, dry mouth, and constipation, Dr. Correll noted that the adverse effects of the novel agent are “mitigated by titration,” with patients taking up to 8 days to reach the full dose.

The result is that the drug was “overall tolerated, and the effect sizes were quite astounding,” he reported.
 

Intermittent, time limited TEAEs

The current trial included 252 patients aged 18-65 years (mean age, 45 years) who were confirmed to have schizophrenia and who had recently experienced a worsening of psychotic symptoms that warranted hospitalization. Three-quarters of the participants were men, and a similar proportion were Black. Approximately one quarter were White.

All were randomly assigned in a 1:1 ratio to receive either xanomeline-trospium or placebo following a 2-week screening period.

Xanomeline and trospium were titrated from 50 mg/20 mg twice daily to 125 mg/30 mg twice daily, and patients were treated for a total of 5 weeks. Efficacy and safety analyses were conducted in those who had received at least one dose of the study drug.

At the end of the treatment period, xanomeline-trospium was associated with a significant 9.6-point reduction in PANSS total scores relative to placebo; scores fell by 21.2 points with the active treatment, vs. 11.6 points with placebo (P < .0001).

The significant improvement in PANSS total score began at week 2 (P < .05) and continued to accrue over the course of the study.

Xanomeline-trospium was also associated with significant reductions in PANSS positive subscale scores in comparison with placebo (P < .0001), as well as with reductions in PANSS negative subscale scores (P < .01) and PANSS Marder negative subscale scores (P < .01).

Although 75.4% of patients who received xanomeline-trospium experienced a TEAE, in comparison with 58.4% of the placebo group, very few experienced a serious TEAE (just 1.6% in both groups).

TEAEs leading to discontinuation occurred in 7.1% of the active-treatment group, vs. 5.6% of the placebo group. The overall discontinuation rates from the trial were 25% and 21%, respectively.

The most common TEAEs with xanomeline-trospium were constipation (21.4%), dyspepsia (19.0%), nausea (19.0%), vomiting (14.3%), and headache (13.5%).

The results showed that cholinergic TEAEs typically began within the first 2 weeks of treatment and were “intermittent and time limited in nature,” the investigators noted. Moreover, average blood pressure levels were “similar” between the xanomeline-trospium and placebo groups “at each time point throughout the trial,” they added.

Dr. Correll reported that whereas the EMERGENT studies are testing xanomeline-trospium as a monotherapy, the ARISE program will be examining it as an “augmentation” treatment. “And that’s relevant because, let’s face it, patients do not switch” treatments, he said.

He suggested that if xanomeline-trospium is able to have a synergistic effect with other drugs, “we might be able to treat people who are currently not benefiting enough from postsynaptic dopamine blockade to maybe get a little bit closer” to the benefits seen with clozapine, which “also has problematic side effects.”
 

‘Really revolutionary’

Following the oral presentation of the study by coauthor Stephen K. Brannan, MD, chief medical officer, Karuna Therapeutics, Boston, the results were warmly received.

Session cochair Mark Weiser, MD, chairman at the department of psychiatry, Sackler School of Medicine, Tel Aviv University, Israel, said the agent is “really revolutionary in the field.

“It’s a non-dopamine compound which helps for schizophrenia, so we’re all very optimistic about it,” Dr. Weiser added.

Nevertheless, he asked Dr. Brannan whether the occurrence of gastrointestinal adverse effects with xanomeline-trospium led to “functional unblinding of the study.”

Dr. Brannan answered that the investigators were “really worried about this prior to EMERGENT-1” but that formal testing suggested it was not a problem.

Dr. Brannan said that although this has not yet been formally tested for the current trial, he believes that it is “highly unlikely” that functional unblinding occurred, inasmuch as the “percentages are about in the same range as we saw in EMERGENT-1.”

Speaking to ECNP Congress Daily in a conference roundup video, session cochair Andreas Reif, MD, PhD, professor of psychiatry, psychosomatic medicine, and psychotherapy at the University Hospital of Frankfurt (Germany), also highlighted the study.

He said that along with a study of dexmedetomidine sublingual film for agitation associated with schizophrenia or bipolar disorder that was also presented in the session, the current trial is “pivotal.”

Dr. Reif noted that the effect size shown with xanomeline-trospium was “really amazing.”

“We are in a really exciting time in treating mental disorders,” he said. “Industry is finally investing again, and really has new compounds that will make it to the market.”

Karuna plans to submit a new drug application with the Food and Drug Administration for KarXT in mid-2023. The drug is also in development for the treatment of psychiatric and neurologic conditions other than schizophrenia, including Alzheimer’s disease.

The study was funded by Karuna Therapeutics. Dr. Correll has reported relationships with Karuna, as well as AbbVie, Acadia, Alkermes, Allergan, Angelini, Aristo, Axsome, Boehringer-Ingelheim, Cardio Diagnostics, Cerevel, CNX Therapeutics, Compass Pathways, Damitsa, Gedeon Richter, Hikma, Holmusk, IntraCellular Therapies, Janssen/J&J, LB Pharma, Lundbeck, MedAvante-ProPhase, MedInCell, Medscape, Merck, Mindpax, Mitsubishi Tanabe Pharma, Mylan, Neurocrine, Newron, Noven, Otsuka, Pfizer, Pharmabrain, PPD Biotech, Recordati, Relmada, Reviva, Rovi, Seqirus, Servier, SK Life Science, Sumitomo Dainippon, Sunovion, Sun Pharma, Supernus, Takeda, Teva, Viatris, Otsuka, and UpToDate.

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

VIENNA – The investigational agent xanomeline-trospium (KarXT, Karuna Therapeutics) achieves significant and clinically meaningful improvements in schizophrenia symptom scores without causing problematic adverse effects, new research suggests.

Results from the phase 3 EMERGENT-2 trial, which included more than 250 patients with schizophrenia, showed that those who received xanomeline-trospium for 5 weeks achieved a significant reduction in Positive and Negative Syndrome Scale (PANSS) total scores of more than nine points compared with their peers who received placebo. In addition, the improvements started at week 2.

Alongside significant reductions in both positive and negative symptoms, the results suggest the agent was well tolerated, with treatment-emergent adverse events (TEAEs) largely mild to moderate and transient in nature.

Lead investigator Christoph U. Correll, MD, professor of psychiatry at the Zucker School of Medicine at Hofstra/Northwell, Uniondale, New York, told this news organization that the upcoming EMERGENT-3 study will have a “European component” and that the “readout is expected most likely in the first quarter of next year.”

Dr. Correll suggested that if leads to “two positive studies and reasonable safety,” the novel agent may become part of the “next generation of antipsychotics that are not related to postsynaptic dopamine blockade.”

The findings for EMERGENT-2, presented at the 35th European College of Neuropsychopharmacology (ECNP) Congress as a poster and as an oral presentation, were an update of topline results released earlier this year.
 

Novel compound

Xanomeline-trospium is a novel compound that combines the dual M1/M4-preferring muscarinic receptor agonist effect of xanomeline with the peripherally restricted muscarinic receptor antagonist effect of trospium.

A previous phase 2 trial that compared the drug with placebo in almost 200 patients suggested it significantly reduced psychosis symptoms, leading to the current phase 3 trial.

Dr. Correll noted that xanomeline-trospium reduces psychosis via a “bottom up and top down approach.”

He said that on one hand, M4 agonism decreases acetylcholine in the ventral tegmental area and the associated stratum, “which then decreases dopamine levels from the bottom up,” while the M1 agonism stimulates GABA and decreases dopamine from the “top down.”

M1 agonism, however, also stimulates the cholinergic system peripherally, “which can give you nausea, vomiting, and also some blood pressure and pulse” problems, Dr. Correll said.

That was the limitation when this approach was studied by Lilly as a treatment for patients with Alzheimer’s disease, but the addition of trospium means “you’re buffering somewhat the cholinergic peripheral effects,” he said.

While that can conversely lead to dyspepsia, dry mouth, and constipation, Dr. Correll noted that the adverse effects of the novel agent are “mitigated by titration,” with patients taking up to 8 days to reach the full dose.

The result is that the drug was “overall tolerated, and the effect sizes were quite astounding,” he reported.
 

Intermittent, time limited TEAEs

The current trial included 252 patients aged 18-65 years (mean age, 45 years) who were confirmed to have schizophrenia and who had recently experienced a worsening of psychotic symptoms that warranted hospitalization. Three-quarters of the participants were men, and a similar proportion were Black. Approximately one quarter were White.

All were randomly assigned in a 1:1 ratio to receive either xanomeline-trospium or placebo following a 2-week screening period.

Xanomeline and trospium were titrated from 50 mg/20 mg twice daily to 125 mg/30 mg twice daily, and patients were treated for a total of 5 weeks. Efficacy and safety analyses were conducted in those who had received at least one dose of the study drug.

At the end of the treatment period, xanomeline-trospium was associated with a significant 9.6-point reduction in PANSS total scores relative to placebo; scores fell by 21.2 points with the active treatment, vs. 11.6 points with placebo (P < .0001).

The significant improvement in PANSS total score began at week 2 (P < .05) and continued to accrue over the course of the study.

Xanomeline-trospium was also associated with significant reductions in PANSS positive subscale scores in comparison with placebo (P < .0001), as well as with reductions in PANSS negative subscale scores (P < .01) and PANSS Marder negative subscale scores (P < .01).

Although 75.4% of patients who received xanomeline-trospium experienced a TEAE, in comparison with 58.4% of the placebo group, very few experienced a serious TEAE (just 1.6% in both groups).

TEAEs leading to discontinuation occurred in 7.1% of the active-treatment group, vs. 5.6% of the placebo group. The overall discontinuation rates from the trial were 25% and 21%, respectively.

The most common TEAEs with xanomeline-trospium were constipation (21.4%), dyspepsia (19.0%), nausea (19.0%), vomiting (14.3%), and headache (13.5%).

The results showed that cholinergic TEAEs typically began within the first 2 weeks of treatment and were “intermittent and time limited in nature,” the investigators noted. Moreover, average blood pressure levels were “similar” between the xanomeline-trospium and placebo groups “at each time point throughout the trial,” they added.

Dr. Correll reported that whereas the EMERGENT studies are testing xanomeline-trospium as a monotherapy, the ARISE program will be examining it as an “augmentation” treatment. “And that’s relevant because, let’s face it, patients do not switch” treatments, he said.

He suggested that if xanomeline-trospium is able to have a synergistic effect with other drugs, “we might be able to treat people who are currently not benefiting enough from postsynaptic dopamine blockade to maybe get a little bit closer” to the benefits seen with clozapine, which “also has problematic side effects.”
 

‘Really revolutionary’

Following the oral presentation of the study by coauthor Stephen K. Brannan, MD, chief medical officer, Karuna Therapeutics, Boston, the results were warmly received.

Session cochair Mark Weiser, MD, chairman at the department of psychiatry, Sackler School of Medicine, Tel Aviv University, Israel, said the agent is “really revolutionary in the field.

“It’s a non-dopamine compound which helps for schizophrenia, so we’re all very optimistic about it,” Dr. Weiser added.

Nevertheless, he asked Dr. Brannan whether the occurrence of gastrointestinal adverse effects with xanomeline-trospium led to “functional unblinding of the study.”

Dr. Brannan answered that the investigators were “really worried about this prior to EMERGENT-1” but that formal testing suggested it was not a problem.

Dr. Brannan said that although this has not yet been formally tested for the current trial, he believes that it is “highly unlikely” that functional unblinding occurred, inasmuch as the “percentages are about in the same range as we saw in EMERGENT-1.”

Speaking to ECNP Congress Daily in a conference roundup video, session cochair Andreas Reif, MD, PhD, professor of psychiatry, psychosomatic medicine, and psychotherapy at the University Hospital of Frankfurt (Germany), also highlighted the study.

He said that along with a study of dexmedetomidine sublingual film for agitation associated with schizophrenia or bipolar disorder that was also presented in the session, the current trial is “pivotal.”

Dr. Reif noted that the effect size shown with xanomeline-trospium was “really amazing.”

“We are in a really exciting time in treating mental disorders,” he said. “Industry is finally investing again, and really has new compounds that will make it to the market.”

Karuna plans to submit a new drug application with the Food and Drug Administration for KarXT in mid-2023. The drug is also in development for the treatment of psychiatric and neurologic conditions other than schizophrenia, including Alzheimer’s disease.

The study was funded by Karuna Therapeutics. Dr. Correll has reported relationships with Karuna, as well as AbbVie, Acadia, Alkermes, Allergan, Angelini, Aristo, Axsome, Boehringer-Ingelheim, Cardio Diagnostics, Cerevel, CNX Therapeutics, Compass Pathways, Damitsa, Gedeon Richter, Hikma, Holmusk, IntraCellular Therapies, Janssen/J&J, LB Pharma, Lundbeck, MedAvante-ProPhase, MedInCell, Medscape, Merck, Mindpax, Mitsubishi Tanabe Pharma, Mylan, Neurocrine, Newron, Noven, Otsuka, Pfizer, Pharmabrain, PPD Biotech, Recordati, Relmada, Reviva, Rovi, Seqirus, Servier, SK Life Science, Sumitomo Dainippon, Sunovion, Sun Pharma, Supernus, Takeda, Teva, Viatris, Otsuka, and UpToDate.

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

VIENNA – The investigational agent xanomeline-trospium (KarXT, Karuna Therapeutics) achieves significant and clinically meaningful improvements in schizophrenia symptom scores without causing problematic adverse effects, new research suggests.

Results from the phase 3 EMERGENT-2 trial, which included more than 250 patients with schizophrenia, showed that those who received xanomeline-trospium for 5 weeks achieved a significant reduction in Positive and Negative Syndrome Scale (PANSS) total scores of more than nine points compared with their peers who received placebo. In addition, the improvements started at week 2.

Alongside significant reductions in both positive and negative symptoms, the results suggest the agent was well tolerated, with treatment-emergent adverse events (TEAEs) largely mild to moderate and transient in nature.

Lead investigator Christoph U. Correll, MD, professor of psychiatry at the Zucker School of Medicine at Hofstra/Northwell, Uniondale, New York, told this news organization that the upcoming EMERGENT-3 study will have a “European component” and that the “readout is expected most likely in the first quarter of next year.”

Dr. Correll suggested that if leads to “two positive studies and reasonable safety,” the novel agent may become part of the “next generation of antipsychotics that are not related to postsynaptic dopamine blockade.”

The findings for EMERGENT-2, presented at the 35th European College of Neuropsychopharmacology (ECNP) Congress as a poster and as an oral presentation, were an update of topline results released earlier this year.
 

Novel compound

Xanomeline-trospium is a novel compound that combines the dual M1/M4-preferring muscarinic receptor agonist effect of xanomeline with the peripherally restricted muscarinic receptor antagonist effect of trospium.

A previous phase 2 trial that compared the drug with placebo in almost 200 patients suggested it significantly reduced psychosis symptoms, leading to the current phase 3 trial.

Dr. Correll noted that xanomeline-trospium reduces psychosis via a “bottom up and top down approach.”

He said that on one hand, M4 agonism decreases acetylcholine in the ventral tegmental area and the associated stratum, “which then decreases dopamine levels from the bottom up,” while the M1 agonism stimulates GABA and decreases dopamine from the “top down.”

M1 agonism, however, also stimulates the cholinergic system peripherally, “which can give you nausea, vomiting, and also some blood pressure and pulse” problems, Dr. Correll said.

That was the limitation when this approach was studied by Lilly as a treatment for patients with Alzheimer’s disease, but the addition of trospium means “you’re buffering somewhat the cholinergic peripheral effects,” he said.

While that can conversely lead to dyspepsia, dry mouth, and constipation, Dr. Correll noted that the adverse effects of the novel agent are “mitigated by titration,” with patients taking up to 8 days to reach the full dose.

The result is that the drug was “overall tolerated, and the effect sizes were quite astounding,” he reported.
 

Intermittent, time limited TEAEs

The current trial included 252 patients aged 18-65 years (mean age, 45 years) who were confirmed to have schizophrenia and who had recently experienced a worsening of psychotic symptoms that warranted hospitalization. Three-quarters of the participants were men, and a similar proportion were Black. Approximately one quarter were White.

All were randomly assigned in a 1:1 ratio to receive either xanomeline-trospium or placebo following a 2-week screening period.

Xanomeline and trospium were titrated from 50 mg/20 mg twice daily to 125 mg/30 mg twice daily, and patients were treated for a total of 5 weeks. Efficacy and safety analyses were conducted in those who had received at least one dose of the study drug.

At the end of the treatment period, xanomeline-trospium was associated with a significant 9.6-point reduction in PANSS total scores relative to placebo; scores fell by 21.2 points with the active treatment, vs. 11.6 points with placebo (P < .0001).

The significant improvement in PANSS total score began at week 2 (P < .05) and continued to accrue over the course of the study.

Xanomeline-trospium was also associated with significant reductions in PANSS positive subscale scores in comparison with placebo (P < .0001), as well as with reductions in PANSS negative subscale scores (P < .01) and PANSS Marder negative subscale scores (P < .01).

Although 75.4% of patients who received xanomeline-trospium experienced a TEAE, in comparison with 58.4% of the placebo group, very few experienced a serious TEAE (just 1.6% in both groups).

TEAEs leading to discontinuation occurred in 7.1% of the active-treatment group, vs. 5.6% of the placebo group. The overall discontinuation rates from the trial were 25% and 21%, respectively.

The most common TEAEs with xanomeline-trospium were constipation (21.4%), dyspepsia (19.0%), nausea (19.0%), vomiting (14.3%), and headache (13.5%).

The results showed that cholinergic TEAEs typically began within the first 2 weeks of treatment and were “intermittent and time limited in nature,” the investigators noted. Moreover, average blood pressure levels were “similar” between the xanomeline-trospium and placebo groups “at each time point throughout the trial,” they added.

Dr. Correll reported that whereas the EMERGENT studies are testing xanomeline-trospium as a monotherapy, the ARISE program will be examining it as an “augmentation” treatment. “And that’s relevant because, let’s face it, patients do not switch” treatments, he said.

He suggested that if xanomeline-trospium is able to have a synergistic effect with other drugs, “we might be able to treat people who are currently not benefiting enough from postsynaptic dopamine blockade to maybe get a little bit closer” to the benefits seen with clozapine, which “also has problematic side effects.”
 

‘Really revolutionary’

Following the oral presentation of the study by coauthor Stephen K. Brannan, MD, chief medical officer, Karuna Therapeutics, Boston, the results were warmly received.

Session cochair Mark Weiser, MD, chairman at the department of psychiatry, Sackler School of Medicine, Tel Aviv University, Israel, said the agent is “really revolutionary in the field.

“It’s a non-dopamine compound which helps for schizophrenia, so we’re all very optimistic about it,” Dr. Weiser added.

Nevertheless, he asked Dr. Brannan whether the occurrence of gastrointestinal adverse effects with xanomeline-trospium led to “functional unblinding of the study.”

Dr. Brannan answered that the investigators were “really worried about this prior to EMERGENT-1” but that formal testing suggested it was not a problem.

Dr. Brannan said that although this has not yet been formally tested for the current trial, he believes that it is “highly unlikely” that functional unblinding occurred, inasmuch as the “percentages are about in the same range as we saw in EMERGENT-1.”

Speaking to ECNP Congress Daily in a conference roundup video, session cochair Andreas Reif, MD, PhD, professor of psychiatry, psychosomatic medicine, and psychotherapy at the University Hospital of Frankfurt (Germany), also highlighted the study.

He said that along with a study of dexmedetomidine sublingual film for agitation associated with schizophrenia or bipolar disorder that was also presented in the session, the current trial is “pivotal.”

Dr. Reif noted that the effect size shown with xanomeline-trospium was “really amazing.”

“We are in a really exciting time in treating mental disorders,” he said. “Industry is finally investing again, and really has new compounds that will make it to the market.”

Karuna plans to submit a new drug application with the Food and Drug Administration for KarXT in mid-2023. The drug is also in development for the treatment of psychiatric and neurologic conditions other than schizophrenia, including Alzheimer’s disease.

The study was funded by Karuna Therapeutics. Dr. Correll has reported relationships with Karuna, as well as AbbVie, Acadia, Alkermes, Allergan, Angelini, Aristo, Axsome, Boehringer-Ingelheim, Cardio Diagnostics, Cerevel, CNX Therapeutics, Compass Pathways, Damitsa, Gedeon Richter, Hikma, Holmusk, IntraCellular Therapies, Janssen/J&J, LB Pharma, Lundbeck, MedAvante-ProPhase, MedInCell, Medscape, Merck, Mindpax, Mitsubishi Tanabe Pharma, Mylan, Neurocrine, Newron, Noven, Otsuka, Pfizer, Pharmabrain, PPD Biotech, Recordati, Relmada, Reviva, Rovi, Seqirus, Servier, SK Life Science, Sumitomo Dainippon, Sunovion, Sun Pharma, Supernus, Takeda, Teva, Viatris, Otsuka, and UpToDate.

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

It is assumed that psychiatrists in general, but particularly in academia, are progressive liberals. There is evidence to support this idea, with a survey finding that more than three-quarters of U.S. psychiatrists are registered Democrats.¹

Other corroborating factors to our field’s progressive tendency include the publication of pseudo-political books like “The Dangerous Case of Donald Trump: 27 Psychiatrists and Mental Health Experts Assess a President” – without a well-known equivalent on the other side.

Additionally, psychiatry has in the recent past, rightfully spent significant effort examining the disproportional trauma faced by patients with underprivileged backgrounds, which is often seen as a political position. The American Psychiatric Association has itself taken a stance on the national debate about abortion to warn against the psychiatric consequences of the Dobbs v. Jackson Supreme Court decision despite the clear political statement it makes.

We understand a likely rationale for psychiatry’s liberal tendency. Most psychiatrists support political objectives that provide resources for the treatment of the severely mentally ill. In general, the psychosocial consequences of mental illness place a downward economic pressure on our patients that leads to poverty and its associated traumas that then tend to feedback to worsen the severity of the illness itself. It is thus natural for psychiatry to promote political causes such as progressivism that focus on the needs of economically and socially struggling communities. If one posits a natural role for psychiatry in promoting the interests of patients, then it is a short leap to psychiatry promoting the political causes of the underprivileged, often in the form of endorsing the Democratic party.

As a result, a proportion of patients come into psychiatric treatment with expectations that their providers will negatively judge them and possibly punish their conservative beliefs or Republican political affiliation. Herein lies a question – “Is psychiatry willing to make 46.9% of Americans uncomfortable?” How should psychiatry address the 46.9% of Americans who voted Republican during the 2020 presidential election? In our desire to support the disadvantaged, how political are we willing to get and at what cost? While we cannot speak for the field as a whole, it is our concern that a vast percentage of Americans feel alienated from talking to us, which is particularly problematic in a field based on mutual trust and understanding.

Dr. Lehman is a professor of psychiatry at the University of California, San Diego. He is codirector of all acute and intensive psychiatric treatment at the Veterans Affairs Medical Center in San Diego, where he practices clinical psychiatry. He has no conflicts of interest. Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. He has no conflicts of interest.

References

1. Sanger-Katz M. Your surgeon is probably a Republican, your psychiatrist probably a Democrat. New York Times. 2016 Oct 6.

2. Ba B et al. Who are the police? Descriptive representation in the coercive arm of government. 2022 Mar 21.

3. Rainey J. Union leader tells Republican convention why cops back Trump. Los Angeles Times. 2020 Aug 26.

4. Igielnik R et al. Trump draws stronger support from veterans than from the public on leadership of U.S. military. Pew Research Center. 2019 July 10.

It is assumed that psychiatrists in general, but particularly in academia, are progressive liberals. There is evidence to support this idea, with a survey finding that more than three-quarters of U.S. psychiatrists are registered Democrats.¹

Other corroborating factors to our field’s progressive tendency include the publication of pseudo-political books like “The Dangerous Case of Donald Trump: 27 Psychiatrists and Mental Health Experts Assess a President” – without a well-known equivalent on the other side.

Additionally, psychiatry has in the recent past, rightfully spent significant effort examining the disproportional trauma faced by patients with underprivileged backgrounds, which is often seen as a political position. The American Psychiatric Association has itself taken a stance on the national debate about abortion to warn against the psychiatric consequences of the Dobbs v. Jackson Supreme Court decision despite the clear political statement it makes.

We understand a likely rationale for psychiatry’s liberal tendency. Most psychiatrists support political objectives that provide resources for the treatment of the severely mentally ill. In general, the psychosocial consequences of mental illness place a downward economic pressure on our patients that leads to poverty and its associated traumas that then tend to feedback to worsen the severity of the illness itself. It is thus natural for psychiatry to promote political causes such as progressivism that focus on the needs of economically and socially struggling communities. If one posits a natural role for psychiatry in promoting the interests of patients, then it is a short leap to psychiatry promoting the political causes of the underprivileged, often in the form of endorsing the Democratic party.

As a result, a proportion of patients come into psychiatric treatment with expectations that their providers will negatively judge them and possibly punish their conservative beliefs or Republican political affiliation. Herein lies a question – “Is psychiatry willing to make 46.9% of Americans uncomfortable?” How should psychiatry address the 46.9% of Americans who voted Republican during the 2020 presidential election? In our desire to support the disadvantaged, how political are we willing to get and at what cost? While we cannot speak for the field as a whole, it is our concern that a vast percentage of Americans feel alienated from talking to us, which is particularly problematic in a field based on mutual trust and understanding.

Dr. Lehman is a professor of psychiatry at the University of California, San Diego. He is codirector of all acute and intensive psychiatric treatment at the Veterans Affairs Medical Center in San Diego, where he practices clinical psychiatry. He has no conflicts of interest. Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. He has no conflicts of interest.

References

1. Sanger-Katz M. Your surgeon is probably a Republican, your psychiatrist probably a Democrat. New York Times. 2016 Oct 6.

2. Ba B et al. Who are the police? Descriptive representation in the coercive arm of government. 2022 Mar 21.

3. Rainey J. Union leader tells Republican convention why cops back Trump. Los Angeles Times. 2020 Aug 26.

4. Igielnik R et al. Trump draws stronger support from veterans than from the public on leadership of U.S. military. Pew Research Center. 2019 July 10.

It is assumed that psychiatrists in general, but particularly in academia, are progressive liberals. There is evidence to support this idea, with a survey finding that more than three-quarters of U.S. psychiatrists are registered Democrats.¹

Other corroborating factors to our field’s progressive tendency include the publication of pseudo-political books like “The Dangerous Case of Donald Trump: 27 Psychiatrists and Mental Health Experts Assess a President” – without a well-known equivalent on the other side.

Additionally, psychiatry has in the recent past, rightfully spent significant effort examining the disproportional trauma faced by patients with underprivileged backgrounds, which is often seen as a political position. The American Psychiatric Association has itself taken a stance on the national debate about abortion to warn against the psychiatric consequences of the Dobbs v. Jackson Supreme Court decision despite the clear political statement it makes.

We understand a likely rationale for psychiatry’s liberal tendency. Most psychiatrists support political objectives that provide resources for the treatment of the severely mentally ill. In general, the psychosocial consequences of mental illness place a downward economic pressure on our patients that leads to poverty and its associated traumas that then tend to feedback to worsen the severity of the illness itself. It is thus natural for psychiatry to promote political causes such as progressivism that focus on the needs of economically and socially struggling communities. If one posits a natural role for psychiatry in promoting the interests of patients, then it is a short leap to psychiatry promoting the political causes of the underprivileged, often in the form of endorsing the Democratic party.

As a result, a proportion of patients come into psychiatric treatment with expectations that their providers will negatively judge them and possibly punish their conservative beliefs or Republican political affiliation. Herein lies a question – “Is psychiatry willing to make 46.9% of Americans uncomfortable?” How should psychiatry address the 46.9% of Americans who voted Republican during the 2020 presidential election? In our desire to support the disadvantaged, how political are we willing to get and at what cost? While we cannot speak for the field as a whole, it is our concern that a vast percentage of Americans feel alienated from talking to us, which is particularly problematic in a field based on mutual trust and understanding.

Dr. Lehman is a professor of psychiatry at the University of California, San Diego. He is codirector of all acute and intensive psychiatric treatment at the Veterans Affairs Medical Center in San Diego, where he practices clinical psychiatry. He has no conflicts of interest. Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. He has no conflicts of interest.

References

1. Sanger-Katz M. Your surgeon is probably a Republican, your psychiatrist probably a Democrat. New York Times. 2016 Oct 6.

2. Ba B et al. Who are the police? Descriptive representation in the coercive arm of government. 2022 Mar 21.

3. Rainey J. Union leader tells Republican convention why cops back Trump. Los Angeles Times. 2020 Aug 26.

4. Igielnik R et al. Trump draws stronger support from veterans than from the public on leadership of U.S. military. Pew Research Center. 2019 July 10.

Electroconvulsive therapy (ECT) is more effective than intravenous (IV) ketamine for patients experiencing a major depressive episode (MDE) in new findings that are in line with the KetECT study – the first head-to-head trial of ketamine and ECT.

The KetECT trial, which was published earlier this year, showed that ECT was more effective than IV ketamine for hospitalized patients with severe depression. ECT yielded higher remission rates and a greater reduction of symptoms.

Despite the apparent superiority of ECT over ketamine, the researchers of the current meta-analysis caution that treatment options for MDE “should still be individualized and patient-centered because ketamine’s faster antidepressant effects may still be desirable for certain patients with severe MDE who require quick recovery from the severity of depression.”

The study was published online in JAMA Psychiatry.
 

Confirmatory data

The review included six clinical trials with 340 patients with MDE. Of those patients, 162 were treated with ECT, and 178 were treated with ketamine. The mean age of the participants ranged from 37 to 52 years.

The primary efficacy outcome of interest was improvement of depressive symptoms.

ECT was superior to ketamine across different depressive symptom measures, reported Taeho Greg Rhee, PhD, of the University of Connecticut, Farmington, and colleagues.

The standardized mean difference (SMD) was –0.59 (95% confidence interval [CI], –0.85 to –0.33) on the Montgomery-Åsberg Depression Rating Scale.

The SMD was –0.83 (95% CI, –1.22 to –0.44] on the Hamilton Depression Rating Scale and –0.86 (95% CI, –1.50 to –0.22) on the Beck Depression Inventory.

The overall pooled SMD for ECT, when compared with ketamine, was –0.69 (95% CI, –0.89 to –0.48), indicating that ECT was more efficacious than ketamine.

The researchers did not find any moderating effects of various factors, including age, male sex, and presence of psychotic features.

For cognition and memory performance, one study reported that the ketamine group outperformed the ECT group in cognition, but the effect size was small to moderate.

A separate study that reported memory performance found no difference between ketamine and ECT, though this study was likely underpowered to detect such differences, with a total sample size of 32.

“Because of underpowered study designs, no firm conclusions regarding cognition and memory performance can be made in this meta-analysis. Future research should address this issue,” the investigators wrote.
 

Unique side effects

Ketamine and ECT had unique adverse effect profiles.

With ketamine, there was a lower risk of headache and muscle pain but a higher risk of transient dissociative or depersonalization symptoms. With ECT, there was a lower risk of blurred vision, vertigo, and diplopia/nystagmus.

Only one study reported suicide attempts and suicide deaths, for which there was no marked difference between ECT and ketamine.

A limitation of the meta-analysis is the low to moderate methodologic quality of the studies that were included, as well as the use of different ketamine and/or ECT treatment protocols, which could have influenced efficacy and safety outcomes.

The researchers noted that more research is needed to optimize long-term treatment outcomes for both ketamine and ECT to prevent relapse, “which is of key importance for clinical practice.”

The study had no specific funding. Dr. Rhee currently serves as a co–editor-in-chief of Mental Health Science and will receive honorarium payments annually from the publisher, John Wiley & Sons. A complete list of the authors’ relevant financial relationships is available with the original article.

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

Electroconvulsive therapy (ECT) is more effective than intravenous (IV) ketamine for patients experiencing a major depressive episode (MDE) in new findings that are in line with the KetECT study – the first head-to-head trial of ketamine and ECT.

The KetECT trial, which was published earlier this year, showed that ECT was more effective than IV ketamine for hospitalized patients with severe depression. ECT yielded higher remission rates and a greater reduction of symptoms.

Despite the apparent superiority of ECT over ketamine, the researchers of the current meta-analysis caution that treatment options for MDE “should still be individualized and patient-centered because ketamine’s faster antidepressant effects may still be desirable for certain patients with severe MDE who require quick recovery from the severity of depression.”

The study was published online in JAMA Psychiatry.
 

Confirmatory data

The review included six clinical trials with 340 patients with MDE. Of those patients, 162 were treated with ECT, and 178 were treated with ketamine. The mean age of the participants ranged from 37 to 52 years.

The primary efficacy outcome of interest was improvement of depressive symptoms.

ECT was superior to ketamine across different depressive symptom measures, reported Taeho Greg Rhee, PhD, of the University of Connecticut, Farmington, and colleagues.

The standardized mean difference (SMD) was –0.59 (95% confidence interval [CI], –0.85 to –0.33) on the Montgomery-Åsberg Depression Rating Scale.

The SMD was –0.83 (95% CI, –1.22 to –0.44] on the Hamilton Depression Rating Scale and –0.86 (95% CI, –1.50 to –0.22) on the Beck Depression Inventory.

The overall pooled SMD for ECT, when compared with ketamine, was –0.69 (95% CI, –0.89 to –0.48), indicating that ECT was more efficacious than ketamine.

The researchers did not find any moderating effects of various factors, including age, male sex, and presence of psychotic features.

For cognition and memory performance, one study reported that the ketamine group outperformed the ECT group in cognition, but the effect size was small to moderate.

A separate study that reported memory performance found no difference between ketamine and ECT, though this study was likely underpowered to detect such differences, with a total sample size of 32.

“Because of underpowered study designs, no firm conclusions regarding cognition and memory performance can be made in this meta-analysis. Future research should address this issue,” the investigators wrote.
 

Unique side effects

Ketamine and ECT had unique adverse effect profiles.

With ketamine, there was a lower risk of headache and muscle pain but a higher risk of transient dissociative or depersonalization symptoms. With ECT, there was a lower risk of blurred vision, vertigo, and diplopia/nystagmus.

Only one study reported suicide attempts and suicide deaths, for which there was no marked difference between ECT and ketamine.

A limitation of the meta-analysis is the low to moderate methodologic quality of the studies that were included, as well as the use of different ketamine and/or ECT treatment protocols, which could have influenced efficacy and safety outcomes.

The researchers noted that more research is needed to optimize long-term treatment outcomes for both ketamine and ECT to prevent relapse, “which is of key importance for clinical practice.”

The study had no specific funding. Dr. Rhee currently serves as a co–editor-in-chief of Mental Health Science and will receive honorarium payments annually from the publisher, John Wiley & Sons. A complete list of the authors’ relevant financial relationships is available with the original article.

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

Electroconvulsive therapy (ECT) is more effective than intravenous (IV) ketamine for patients experiencing a major depressive episode (MDE) in new findings that are in line with the KetECT study – the first head-to-head trial of ketamine and ECT.

The KetECT trial, which was published earlier this year, showed that ECT was more effective than IV ketamine for hospitalized patients with severe depression. ECT yielded higher remission rates and a greater reduction of symptoms.

Despite the apparent superiority of ECT over ketamine, the researchers of the current meta-analysis caution that treatment options for MDE “should still be individualized and patient-centered because ketamine’s faster antidepressant effects may still be desirable for certain patients with severe MDE who require quick recovery from the severity of depression.”

The study was published online in JAMA Psychiatry.
 

Confirmatory data

The review included six clinical trials with 340 patients with MDE. Of those patients, 162 were treated with ECT, and 178 were treated with ketamine. The mean age of the participants ranged from 37 to 52 years.

The primary efficacy outcome of interest was improvement of depressive symptoms.

ECT was superior to ketamine across different depressive symptom measures, reported Taeho Greg Rhee, PhD, of the University of Connecticut, Farmington, and colleagues.

The standardized mean difference (SMD) was –0.59 (95% confidence interval [CI], –0.85 to –0.33) on the Montgomery-Åsberg Depression Rating Scale.

The SMD was –0.83 (95% CI, –1.22 to –0.44] on the Hamilton Depression Rating Scale and –0.86 (95% CI, –1.50 to –0.22) on the Beck Depression Inventory.

The overall pooled SMD for ECT, when compared with ketamine, was –0.69 (95% CI, –0.89 to –0.48), indicating that ECT was more efficacious than ketamine.

The researchers did not find any moderating effects of various factors, including age, male sex, and presence of psychotic features.

For cognition and memory performance, one study reported that the ketamine group outperformed the ECT group in cognition, but the effect size was small to moderate.

A separate study that reported memory performance found no difference between ketamine and ECT, though this study was likely underpowered to detect such differences, with a total sample size of 32.

“Because of underpowered study designs, no firm conclusions regarding cognition and memory performance can be made in this meta-analysis. Future research should address this issue,” the investigators wrote.
 

Unique side effects

Ketamine and ECT had unique adverse effect profiles.

With ketamine, there was a lower risk of headache and muscle pain but a higher risk of transient dissociative or depersonalization symptoms. With ECT, there was a lower risk of blurred vision, vertigo, and diplopia/nystagmus.

Only one study reported suicide attempts and suicide deaths, for which there was no marked difference between ECT and ketamine.

A limitation of the meta-analysis is the low to moderate methodologic quality of the studies that were included, as well as the use of different ketamine and/or ECT treatment protocols, which could have influenced efficacy and safety outcomes.

The researchers noted that more research is needed to optimize long-term treatment outcomes for both ketamine and ECT to prevent relapse, “which is of key importance for clinical practice.”

The study had no specific funding. Dr. Rhee currently serves as a co–editor-in-chief of Mental Health Science and will receive honorarium payments annually from the publisher, John Wiley & Sons. A complete list of the authors’ relevant financial relationships is available with the original article.

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

As monotherapy, the experimental drug REL-1017 (Relmada Therapeutics) has failed to show statistically significant improvement in depression symptoms compared with placebo in topline results from the phase 3 RELIANCE III trial.

The negative monotherapy data come on the heels of earlier phase 2 data showing a benefit of REL-1017 when used as add-on therapy for adults with major depressive disorder (MDD).

Despite the monotherapy results, Relmada reported in a release that it is continuing to enroll patients in two other phase 3 trials. However, RELIANCE I and RELIANCE II are assessing the drug only as adjunctive therapy.

“While these RELIANCE III results are disappointing for patients, the need for new, safe, and effective treatments for MDD continues to exist,” Maurizio Fava, MD, psychiatrist in chief at Massachusetts General Hospital, Boston, said in the release.

“We look forward to the data from the ongoing RELIANCE I and II trials of REL-1017, a potential new therapy for the adjunctive treatment of MDD,” Dr. Fava added.

REL-1017 is a novel N-methyl-D-aspartate receptor channel blocker that preferentially targets hyperactive channels while maintaining physiologic glutamatergic neurotransmission. RELIANCE III tested REL-1017 against placebo for 28 days in 232 adults with MDD.

The study did not achieve its primary endpoint, which was a statistically significant improvement in symptoms of depression compared with placebo, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) on day 28.

At that time point, the REL-1017 treatment group showed a reduction in MADRS scores of 14.8 points, vs. 13.9 points for the placebo arm.

The placebo response was “higher than expected” – placebo “dramatically” outperformed REL-1017 at some study sites, Relmada said in the release.

The company added that it is “investigating the nature of these results.”

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

As monotherapy, the experimental drug REL-1017 (Relmada Therapeutics) has failed to show statistically significant improvement in depression symptoms compared with placebo in topline results from the phase 3 RELIANCE III trial.

The negative monotherapy data come on the heels of earlier phase 2 data showing a benefit of REL-1017 when used as add-on therapy for adults with major depressive disorder (MDD).

Despite the monotherapy results, Relmada reported in a release that it is continuing to enroll patients in two other phase 3 trials. However, RELIANCE I and RELIANCE II are assessing the drug only as adjunctive therapy.

“While these RELIANCE III results are disappointing for patients, the need for new, safe, and effective treatments for MDD continues to exist,” Maurizio Fava, MD, psychiatrist in chief at Massachusetts General Hospital, Boston, said in the release.

“We look forward to the data from the ongoing RELIANCE I and II trials of REL-1017, a potential new therapy for the adjunctive treatment of MDD,” Dr. Fava added.

REL-1017 is a novel N-methyl-D-aspartate receptor channel blocker that preferentially targets hyperactive channels while maintaining physiologic glutamatergic neurotransmission. RELIANCE III tested REL-1017 against placebo for 28 days in 232 adults with MDD.

The study did not achieve its primary endpoint, which was a statistically significant improvement in symptoms of depression compared with placebo, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) on day 28.

At that time point, the REL-1017 treatment group showed a reduction in MADRS scores of 14.8 points, vs. 13.9 points for the placebo arm.

The placebo response was “higher than expected” – placebo “dramatically” outperformed REL-1017 at some study sites, Relmada said in the release.

The company added that it is “investigating the nature of these results.”

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

As monotherapy, the experimental drug REL-1017 (Relmada Therapeutics) has failed to show statistically significant improvement in depression symptoms compared with placebo in topline results from the phase 3 RELIANCE III trial.

The negative monotherapy data come on the heels of earlier phase 2 data showing a benefit of REL-1017 when used as add-on therapy for adults with major depressive disorder (MDD).

Despite the monotherapy results, Relmada reported in a release that it is continuing to enroll patients in two other phase 3 trials. However, RELIANCE I and RELIANCE II are assessing the drug only as adjunctive therapy.

“While these RELIANCE III results are disappointing for patients, the need for new, safe, and effective treatments for MDD continues to exist,” Maurizio Fava, MD, psychiatrist in chief at Massachusetts General Hospital, Boston, said in the release.

“We look forward to the data from the ongoing RELIANCE I and II trials of REL-1017, a potential new therapy for the adjunctive treatment of MDD,” Dr. Fava added.

REL-1017 is a novel N-methyl-D-aspartate receptor channel blocker that preferentially targets hyperactive channels while maintaining physiologic glutamatergic neurotransmission. RELIANCE III tested REL-1017 against placebo for 28 days in 232 adults with MDD.

The study did not achieve its primary endpoint, which was a statistically significant improvement in symptoms of depression compared with placebo, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) on day 28.

At that time point, the REL-1017 treatment group showed a reduction in MADRS scores of 14.8 points, vs. 13.9 points for the placebo arm.

The placebo response was “higher than expected” – placebo “dramatically” outperformed REL-1017 at some study sites, Relmada said in the release.

The company added that it is “investigating the nature of these results.”

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

Mental health symptoms at the time of admission to an inpatient psychiatric hospital were significantly more severe during the COVID-19 pandemic compared to the time before the pandemic, based on data from more than 500 individuals.

“Those with preexisting mental health conditions may be particularly vulnerable to these effects because they are more susceptible to experiencing high levels of stress during a crisis and are more likely to experience isolation/despair during confinement compared to the general population,” wrote Danna Ramirez of The Menninger Clinic, Houston, and colleagues.

In a study published in Psychiatry Research , the investigators compared data from 142 adolescents aged 12-17 years and 470 adults aged 18-79 years who were admitted to an inpatient psychiatric hospital in Houston. Of these, 65 adolescents and 235 adults were admitted before the pandemic, and 77 adolescents and 235 adults were admitted during the pandemic.

Clinical outcomes were scores on the Generalized Anxiety Disorder Scale (GAD-7), the Patient Health Questionnaire (PHQ-9), the Patient Health Questionnaire for Adolescents (PHQ-A), the Difficulties in Emotion Regulation Scale–Short Form (DERS-SF), the World Health Organization Disability Assessment Scale (WHODAS), the World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHOASSIST), the Pittsburgh Sleep Quality Index (PSQI), the Disturbing Dream and Nightmare Severity Index (DDNSI), and the Suicide Behaviors Questionnaire–Revised (SBQ-R).

Overall, adults admitted during the pandemic had significantly higher levels of anxiety, depression, emotional dysregulation, and disability (P < .001 for all) as well as nightmares (P = .013) compared to those admitted prior to the pandemic.

Among adolescents, measures of anxiety, depression, and sleep quality were significantly higher at admission during the pandemic compared to prior to the pandemic (P = .005, P = .005, and P = .011, respectively)

Reasons for the increase in symptom severity remain unclear, but include the possibility that individuals with preexisting mental illness simply became more ill; or that individuals with symptoms delayed hospital admission out of fear of exposure to COVID-19, which resulted in more severe symptoms at admission, the researchers wrote in their discussion.

The findings were limited by several factors, including the primarily White population and the reliance on self-reports, the researchers noted. Another limitation was the lack of differentiation between patients who may have had COVID-19 before hospitalization and those who did not, so the researchers could not determine whether the virus itself played a biological role in symptom severity.

However, the results support data from previous studies and identify increased psychiatry symptom severity for patients admitted for inpatient psychiatry care during the pandemic, they said. Although resources are scarce, the findings emphasize that mental health needs, especially for those with preexisting conditions, should not be overlooked, and continuity and expansion of access to mental health care for all should be prioritized, they concluded.

The study was supported by The Menninger Clinic and The Menninger Clinic Foundation. The researchers had no financial conflicts to disclose.

Mental health symptoms at the time of admission to an inpatient psychiatric hospital were significantly more severe during the COVID-19 pandemic compared to the time before the pandemic, based on data from more than 500 individuals.

“Those with preexisting mental health conditions may be particularly vulnerable to these effects because they are more susceptible to experiencing high levels of stress during a crisis and are more likely to experience isolation/despair during confinement compared to the general population,” wrote Danna Ramirez of The Menninger Clinic, Houston, and colleagues.

In a study published in Psychiatry Research , the investigators compared data from 142 adolescents aged 12-17 years and 470 adults aged 18-79 years who were admitted to an inpatient psychiatric hospital in Houston. Of these, 65 adolescents and 235 adults were admitted before the pandemic, and 77 adolescents and 235 adults were admitted during the pandemic.

Clinical outcomes were scores on the Generalized Anxiety Disorder Scale (GAD-7), the Patient Health Questionnaire (PHQ-9), the Patient Health Questionnaire for Adolescents (PHQ-A), the Difficulties in Emotion Regulation Scale–Short Form (DERS-SF), the World Health Organization Disability Assessment Scale (WHODAS), the World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHOASSIST), the Pittsburgh Sleep Quality Index (PSQI), the Disturbing Dream and Nightmare Severity Index (DDNSI), and the Suicide Behaviors Questionnaire–Revised (SBQ-R).

Overall, adults admitted during the pandemic had significantly higher levels of anxiety, depression, emotional dysregulation, and disability (P < .001 for all) as well as nightmares (P = .013) compared to those admitted prior to the pandemic.

Among adolescents, measures of anxiety, depression, and sleep quality were significantly higher at admission during the pandemic compared to prior to the pandemic (P = .005, P = .005, and P = .011, respectively)

Reasons for the increase in symptom severity remain unclear, but include the possibility that individuals with preexisting mental illness simply became more ill; or that individuals with symptoms delayed hospital admission out of fear of exposure to COVID-19, which resulted in more severe symptoms at admission, the researchers wrote in their discussion.

The findings were limited by several factors, including the primarily White population and the reliance on self-reports, the researchers noted. Another limitation was the lack of differentiation between patients who may have had COVID-19 before hospitalization and those who did not, so the researchers could not determine whether the virus itself played a biological role in symptom severity.

However, the results support data from previous studies and identify increased psychiatry symptom severity for patients admitted for inpatient psychiatry care during the pandemic, they said. Although resources are scarce, the findings emphasize that mental health needs, especially for those with preexisting conditions, should not be overlooked, and continuity and expansion of access to mental health care for all should be prioritized, they concluded.

The study was supported by The Menninger Clinic and The Menninger Clinic Foundation. The researchers had no financial conflicts to disclose.

Mental health symptoms at the time of admission to an inpatient psychiatric hospital were significantly more severe during the COVID-19 pandemic compared to the time before the pandemic, based on data from more than 500 individuals.

“Those with preexisting mental health conditions may be particularly vulnerable to these effects because they are more susceptible to experiencing high levels of stress during a crisis and are more likely to experience isolation/despair during confinement compared to the general population,” wrote Danna Ramirez of The Menninger Clinic, Houston, and colleagues.

In a study published in Psychiatry Research , the investigators compared data from 142 adolescents aged 12-17 years and 470 adults aged 18-79 years who were admitted to an inpatient psychiatric hospital in Houston. Of these, 65 adolescents and 235 adults were admitted before the pandemic, and 77 adolescents and 235 adults were admitted during the pandemic.

Clinical outcomes were scores on the Generalized Anxiety Disorder Scale (GAD-7), the Patient Health Questionnaire (PHQ-9), the Patient Health Questionnaire for Adolescents (PHQ-A), the Difficulties in Emotion Regulation Scale–Short Form (DERS-SF), the World Health Organization Disability Assessment Scale (WHODAS), the World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHOASSIST), the Pittsburgh Sleep Quality Index (PSQI), the Disturbing Dream and Nightmare Severity Index (DDNSI), and the Suicide Behaviors Questionnaire–Revised (SBQ-R).

Overall, adults admitted during the pandemic had significantly higher levels of anxiety, depression, emotional dysregulation, and disability (P < .001 for all) as well as nightmares (P = .013) compared to those admitted prior to the pandemic.

Among adolescents, measures of anxiety, depression, and sleep quality were significantly higher at admission during the pandemic compared to prior to the pandemic (P = .005, P = .005, and P = .011, respectively)

Reasons for the increase in symptom severity remain unclear, but include the possibility that individuals with preexisting mental illness simply became more ill; or that individuals with symptoms delayed hospital admission out of fear of exposure to COVID-19, which resulted in more severe symptoms at admission, the researchers wrote in their discussion.

The findings were limited by several factors, including the primarily White population and the reliance on self-reports, the researchers noted. Another limitation was the lack of differentiation between patients who may have had COVID-19 before hospitalization and those who did not, so the researchers could not determine whether the virus itself played a biological role in symptom severity.

However, the results support data from previous studies and identify increased psychiatry symptom severity for patients admitted for inpatient psychiatry care during the pandemic, they said. Although resources are scarce, the findings emphasize that mental health needs, especially for those with preexisting conditions, should not be overlooked, and continuity and expansion of access to mental health care for all should be prioritized, they concluded.

The study was supported by The Menninger Clinic and The Menninger Clinic Foundation. The researchers had no financial conflicts to disclose.

Tumor vs. saxophone: The surgical grudge match

Brain surgery is a notoriously difficult task. There’s a reason we say, “Well, at least it’s not brain surgery” when we’re trying to convince someone that a task isn’t that tough. Make one wrong incision, cut the wrong neuron, and it’s goodbye higher cognitive function. And most people appreciate thinking. Crazy, right?

One would imagine that the act of brain surgery would become even more difficult when the patient brings his saxophone and plays it randomly throughout the operation. It’s a hospital, after all, not a jazz club. Patients don’t get to play musical instruments during other surgeries. Why should brain surgery patients get special treatment?

Paideia International Hospital

As it turns out, the musical performance was actually quite helpful. A man in Italy had a brain tumor in a particularly complex area, and he’s left-handed, which apparently makes the brain’s neural pathways much more complicated. Plus, he insisted that he retain his musical ability after the surgery. So he and his medical team had a crazy thought: Why not play the saxophone throughout the surgery? After all, according to head surgeon Christian Brogna, MD, playing an instrument means you understand music, which tests many higher cognitive functions such as coordination, mathematics, and memory.

And so, at various points throughout the 9-hour surgery, the patient played his saxophone for his doctors. Doing so allowed the surgeons to map the patient’s brain in a more complete and personalized fashion. With that extra knowledge, they were able to successfully remove the tumor while maintaining the patient’s musical ability, and the patient was discharged on Oct. 13, just 3 days after his operation.

While we’re happy the patient recovered, we do have to question his choice of music. During the surgery, he played the theme to the 1970 movie “Love Story” and the Italian national anthem. Perfectly fine pieces, no doubt, but the saxophone solo in “Jungleland” exists. And we could listen to that for 9 hours straight. In fact, we do that every Friday in the LOTME office.
 

Basketball has the Big Dance. Mosquitoes get the Big Sniff

In this week’s installment of our seemingly never-ending series, “Mosquitoes and the scientists who love them,” we visit The Rockefeller University in New York, where the olfactory capabilities of Aedes Aegypti – the primary vector species for Zika, dengue, yellow fever, and chikungunya – became the subject of a round robin–style tournament.

Courtesy Wikimedia Commons/Muhammad Mahdi Karim/Creative Commons License

First things first, though. If you’re going to test mosquito noses, you have to give them something to smell. The researchers enrolled eight humans who were willing to wear nylon stockings on their forearms for 6 hours a day for multiple days. “Over the next few years, the researchers tested the nylons against each other in all possible pairings,” Leslie B. Vosshall, PhD, and associates said in a statement from the university. In other words, mosquito March Madness.

Nylons from different participants were hooked up in pairs to an olfactometer assay consisting of a plexiglass chamber divided into two tubes, each ending in a box that held a stocking. The mosquitoes were placed in the main chamber and observed as they flew down the tubes toward one stocking or the other.

Eventually, the “winner” of the “tournament” was Subject 33. And no, we don’t know why there was a Subject 33 since the study involved only eight participants. We do know that the nylons worn by Subject 33 were “four times more attractive to the mosquitoes than the next most-attractive study participant, and an astonishing 100 times more appealing than the least attractive, Subject 19,” according to the written statement.

Chemical analysis identified 50 molecular compounds that were elevated in the sebum of the high-attracting participants, and eventually the investigators discovered that mosquito magnets produced carboxylic acids at much higher levels than the less-attractive volunteers.

We could go on about the research team genetically engineering mosquitoes without odor receptors, but we have to save something for later. Tune in again next week for another exciting episode of “Mosquitoes and the scientists who love them.”
 

Are women better with words?

Men vs. Women is probably the oldest argument in the book, but there may now be movement. Researchers have been able not only to shift the advantage toward women, but also to use that knowledge to medical advantage.

AndrewLobov/Depositphotos

When it comes to the matter of words and remembering them, women apparently have men beat. The margin is small, said lead author Marco Hirnstein, PhD, of the University of Bergen, Norway, but, after performing a meta-analysis of 168 published studies and PhD theses involving more than 350,000 participants, it’s pretty clear. The research supports women’s advantage over men in recall, verbal fluency (categorical and phonemic), and recognition.

So how is this information useful from a medical standpoint?

Dr. Hirnstein and colleagues suggested that this information can help in interpreting diagnostic assessment results. The example given was dementia diagnosis. Since women are underdiagnosed because their baseline exceeds average while men are overdiagnosed, taking gender and performance into account could clear up or catch cases that might otherwise slip through the cracks.

Now, let’s just put this part of the debate to rest and take this not only as a win for women but for science as well.

Tumor vs. saxophone: The surgical grudge match

Brain surgery is a notoriously difficult task. There’s a reason we say, “Well, at least it’s not brain surgery” when we’re trying to convince someone that a task isn’t that tough. Make one wrong incision, cut the wrong neuron, and it’s goodbye higher cognitive function. And most people appreciate thinking. Crazy, right?

One would imagine that the act of brain surgery would become even more difficult when the patient brings his saxophone and plays it randomly throughout the operation. It’s a hospital, after all, not a jazz club. Patients don’t get to play musical instruments during other surgeries. Why should brain surgery patients get special treatment?

Paideia International Hospital

As it turns out, the musical performance was actually quite helpful. A man in Italy had a brain tumor in a particularly complex area, and he’s left-handed, which apparently makes the brain’s neural pathways much more complicated. Plus, he insisted that he retain his musical ability after the surgery. So he and his medical team had a crazy thought: Why not play the saxophone throughout the surgery? After all, according to head surgeon Christian Brogna, MD, playing an instrument means you understand music, which tests many higher cognitive functions such as coordination, mathematics, and memory.

And so, at various points throughout the 9-hour surgery, the patient played his saxophone for his doctors. Doing so allowed the surgeons to map the patient’s brain in a more complete and personalized fashion. With that extra knowledge, they were able to successfully remove the tumor while maintaining the patient’s musical ability, and the patient was discharged on Oct. 13, just 3 days after his operation.

While we’re happy the patient recovered, we do have to question his choice of music. During the surgery, he played the theme to the 1970 movie “Love Story” and the Italian national anthem. Perfectly fine pieces, no doubt, but the saxophone solo in “Jungleland” exists. And we could listen to that for 9 hours straight. In fact, we do that every Friday in the LOTME office.
 

Basketball has the Big Dance. Mosquitoes get the Big Sniff

In this week’s installment of our seemingly never-ending series, “Mosquitoes and the scientists who love them,” we visit The Rockefeller University in New York, where the olfactory capabilities of Aedes Aegypti – the primary vector species for Zika, dengue, yellow fever, and chikungunya – became the subject of a round robin–style tournament.

Courtesy Wikimedia Commons/Muhammad Mahdi Karim/Creative Commons License

First things first, though. If you’re going to test mosquito noses, you have to give them something to smell. The researchers enrolled eight humans who were willing to wear nylon stockings on their forearms for 6 hours a day for multiple days. “Over the next few years, the researchers tested the nylons against each other in all possible pairings,” Leslie B. Vosshall, PhD, and associates said in a statement from the university. In other words, mosquito March Madness.

Nylons from different participants were hooked up in pairs to an olfactometer assay consisting of a plexiglass chamber divided into two tubes, each ending in a box that held a stocking. The mosquitoes were placed in the main chamber and observed as they flew down the tubes toward one stocking or the other.

Eventually, the “winner” of the “tournament” was Subject 33. And no, we don’t know why there was a Subject 33 since the study involved only eight participants. We do know that the nylons worn by Subject 33 were “four times more attractive to the mosquitoes than the next most-attractive study participant, and an astonishing 100 times more appealing than the least attractive, Subject 19,” according to the written statement.

Chemical analysis identified 50 molecular compounds that were elevated in the sebum of the high-attracting participants, and eventually the investigators discovered that mosquito magnets produced carboxylic acids at much higher levels than the less-attractive volunteers.

We could go on about the research team genetically engineering mosquitoes without odor receptors, but we have to save something for later. Tune in again next week for another exciting episode of “Mosquitoes and the scientists who love them.”
 

Are women better with words?

Men vs. Women is probably the oldest argument in the book, but there may now be movement. Researchers have been able not only to shift the advantage toward women, but also to use that knowledge to medical advantage.

AndrewLobov/Depositphotos

When it comes to the matter of words and remembering them, women apparently have men beat. The margin is small, said lead author Marco Hirnstein, PhD, of the University of Bergen, Norway, but, after performing a meta-analysis of 168 published studies and PhD theses involving more than 350,000 participants, it’s pretty clear. The research supports women’s advantage over men in recall, verbal fluency (categorical and phonemic), and recognition.

So how is this information useful from a medical standpoint?

Dr. Hirnstein and colleagues suggested that this information can help in interpreting diagnostic assessment results. The example given was dementia diagnosis. Since women are underdiagnosed because their baseline exceeds average while men are overdiagnosed, taking gender and performance into account could clear up or catch cases that might otherwise slip through the cracks.

Now, let’s just put this part of the debate to rest and take this not only as a win for women but for science as well.

Tumor vs. saxophone: The surgical grudge match

Brain surgery is a notoriously difficult task. There’s a reason we say, “Well, at least it’s not brain surgery” when we’re trying to convince someone that a task isn’t that tough. Make one wrong incision, cut the wrong neuron, and it’s goodbye higher cognitive function. And most people appreciate thinking. Crazy, right?

One would imagine that the act of brain surgery would become even more difficult when the patient brings his saxophone and plays it randomly throughout the operation. It’s a hospital, after all, not a jazz club. Patients don’t get to play musical instruments during other surgeries. Why should brain surgery patients get special treatment?

Paideia International Hospital

As it turns out, the musical performance was actually quite helpful. A man in Italy had a brain tumor in a particularly complex area, and he’s left-handed, which apparently makes the brain’s neural pathways much more complicated. Plus, he insisted that he retain his musical ability after the surgery. So he and his medical team had a crazy thought: Why not play the saxophone throughout the surgery? After all, according to head surgeon Christian Brogna, MD, playing an instrument means you understand music, which tests many higher cognitive functions such as coordination, mathematics, and memory.

And so, at various points throughout the 9-hour surgery, the patient played his saxophone for his doctors. Doing so allowed the surgeons to map the patient’s brain in a more complete and personalized fashion. With that extra knowledge, they were able to successfully remove the tumor while maintaining the patient’s musical ability, and the patient was discharged on Oct. 13, just 3 days after his operation.

While we’re happy the patient recovered, we do have to question his choice of music. During the surgery, he played the theme to the 1970 movie “Love Story” and the Italian national anthem. Perfectly fine pieces, no doubt, but the saxophone solo in “Jungleland” exists. And we could listen to that for 9 hours straight. In fact, we do that every Friday in the LOTME office.
 

Basketball has the Big Dance. Mosquitoes get the Big Sniff

In this week’s installment of our seemingly never-ending series, “Mosquitoes and the scientists who love them,” we visit The Rockefeller University in New York, where the olfactory capabilities of Aedes Aegypti – the primary vector species for Zika, dengue, yellow fever, and chikungunya – became the subject of a round robin–style tournament.

Courtesy Wikimedia Commons/Muhammad Mahdi Karim/Creative Commons License

First things first, though. If you’re going to test mosquito noses, you have to give them something to smell. The researchers enrolled eight humans who were willing to wear nylon stockings on their forearms for 6 hours a day for multiple days. “Over the next few years, the researchers tested the nylons against each other in all possible pairings,” Leslie B. Vosshall, PhD, and associates said in a statement from the university. In other words, mosquito March Madness.

Nylons from different participants were hooked up in pairs to an olfactometer assay consisting of a plexiglass chamber divided into two tubes, each ending in a box that held a stocking. The mosquitoes were placed in the main chamber and observed as they flew down the tubes toward one stocking or the other.

Eventually, the “winner” of the “tournament” was Subject 33. And no, we don’t know why there was a Subject 33 since the study involved only eight participants. We do know that the nylons worn by Subject 33 were “four times more attractive to the mosquitoes than the next most-attractive study participant, and an astonishing 100 times more appealing than the least attractive, Subject 19,” according to the written statement.

Chemical analysis identified 50 molecular compounds that were elevated in the sebum of the high-attracting participants, and eventually the investigators discovered that mosquito magnets produced carboxylic acids at much higher levels than the less-attractive volunteers.

We could go on about the research team genetically engineering mosquitoes without odor receptors, but we have to save something for later. Tune in again next week for another exciting episode of “Mosquitoes and the scientists who love them.”
 

Are women better with words?

Men vs. Women is probably the oldest argument in the book, but there may now be movement. Researchers have been able not only to shift the advantage toward women, but also to use that knowledge to medical advantage.

AndrewLobov/Depositphotos

When it comes to the matter of words and remembering them, women apparently have men beat. The margin is small, said lead author Marco Hirnstein, PhD, of the University of Bergen, Norway, but, after performing a meta-analysis of 168 published studies and PhD theses involving more than 350,000 participants, it’s pretty clear. The research supports women’s advantage over men in recall, verbal fluency (categorical and phonemic), and recognition.

So how is this information useful from a medical standpoint?

Dr. Hirnstein and colleagues suggested that this information can help in interpreting diagnostic assessment results. The example given was dementia diagnosis. Since women are underdiagnosed because their baseline exceeds average while men are overdiagnosed, taking gender and performance into account could clear up or catch cases that might otherwise slip through the cracks.

Now, let’s just put this part of the debate to rest and take this not only as a win for women but for science as well.

VIENNA – Individuals born to younger or older parents are at increased risk of developing bipolar disorder, new research suggests.

Results from a meta-analysis of more than 210,000 patients with bipolar disorder and over 13 million healthy individuals showed that children of mothers younger than 20 years had a 23% increased risk for bipolar disorder vs. those whose parents were aged 25-29 years. For participants whose mothers were aged 35-39 years, there was a 10% increased risk for bipolar disorder, which rose to 20% if the mother was aged 40 or older.

Having a father younger than 20 years conferred a 29% increased risk for bipolar disorder, which was the same increase in risk found in individuals whose fathers were aged 45 years or older.

These findings, which are an update of data published in the journal European Pharmacology, were presented at the 35th European College of Neuropsychopharmacology (ECNP) Congress.
 

Fourteen studies included

Previous studies have suggested that parental age at birth is a risk factor for several psychiatric disorders in offspring, including bipolar disorder, and that advanced parental age, specifically, is associated with earlier onset schizophrenia.

To investigate further, the current researchers conducted a systematic review and meta-analysis, searching the PubMed/MEDLINE, EMBASE, Scopus, and PsychINFO databases for relevant studies published to Dec. 1, 2021.

From 712 studies initially identified, 16 met all the inclusion criteria and 14 were included in the quantitative analysis.

Five studies reported only paternal age and risk for bipolar disorder in their offspring, one included just maternal age, and eight reported both maternal and paternal age in relation to the risk for offspring bipolar disorder.

Individuals with a history of any psychiatric disorders were excluded, leaving a total of 13.4 million individuals without bipolar disorder and 217,089 who had received a diagnosis for the disorder.

The investigators also corrected for both socioeconomic status and, when assessing the impact of maternal or paternal age at birth, corrected for the age of the other parent. However, they were unable to correct for the number of children in a family.

Results after stratifying maternal and paternal age showed that, compared with those born to parents aged 25-29 years, there was an increased risk for bipolar disorder in the offspring of both fathers and mothers younger than 20 years of age, with adjusted odds ratios of 1.29 (95% confidence interval, 1.13-1.48) and 1.23 (95% CI, 1.14-1.33), respectively.

Compared with those aged 25-29 years, there was also an increased risk for bipolar disorder in children born to mothers aged 35-39 years (adjusted OR, 1.1; 95% CI, 1.01-1.19) and aged 40 or older (OR, 1.2; 95% CI, 1.02-1.40).

Among fathers, there was increased risk for offspring bipolar disorder in those aged 45 or older vs. those aged 25-29 years (adjusted OR, 1.29; 95% CI, 1.15-1.46).
 

Several hypotheses

There are several hypotheses that could explain the results, lead study author Giovanna Fico, MD, bipolar and depressive disorders unit, Hospital Clínic Barcelona, told this news organization.

In older age, it may be “more related to genetic or epigenetic modification, especially in fathers,” Dr. Fico said. “Some studies have shown that there are de novo mutations in the germ lines, which increase the risk of several diseases, including schizophrenia.”

In younger individuals, there could be a “mixed effect between sociocultural factors, such as substance abuse, low educational status,” and other issues, Dr. Fico noted.

Moreover, as bipolar disorder onset can be as late as 30 years of age, the younger group could include “undiagnosed patients with bipolar disorder, which would increase the risk” of the disease in their offspring, she added.

Dr. Fico noted the investigators are now planning on studying the impact of environmental factors such as pollution, climate change, and urbanization on risk for bipolar disorder, with the aim of being better able to inform parents or to develop prevention strategies.

Psychoeducation is “very common for infertility, birth defects, and Down syndrome, but it’s not so common for psychiatric disorders because we need more data. But I think it’s important that parents know they have an increased risk,” she said.

Nevertheless, “We must stress that this risk is moderate, and it must be kept in perspective,” Dr. Fico said in a news release.
 

‘Exciting’ questions raised

The study “raises several exciting research questions, including the possibility of early prevention and intervention,” Maj Vinberg, MD, PhD, clinical professor, department of clinical medicine, University of Copenhagen, said in the release.

She said she agrees there are likely to be different factors at play at different ages, with the risk for bipolar disorder associated with younger-age parenthood more likely to be related to socioeconomic status.

For older parents, “there has been a lot of speculation around the father’s age especially, which everybody thought didn’t matter,” said Dr. Vinberg, who was not involved with the research.

“But you might have some epigenetic changes as you grow older that might transfer into the next generation,” given that there is 20 years of additional exposure to potential epigenetic changes between a man aged 25 years and one aged 45 years, she noted.

Dr. Vinberg also highlighted that there could be cases of undiagnosed bipolar disorder among the younger parents, and she noted that “men with bipolar disorder tend to have more children,” particularly during manic phases.

She explained that if someone were to get divorced at 35 years of age, then have a new manic episode at 45 “and have a new wife and children, I don’t know whether it’s possible to correct for that.”

The research is supported by a fellowship from “la Caixa” Foundation. The investigators have reported no relevant financial relationships. Dr. Vinberg reported having relationships with Lundbeck and Janssen.

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

VIENNA – Individuals born to younger or older parents are at increased risk of developing bipolar disorder, new research suggests.

Results from a meta-analysis of more than 210,000 patients with bipolar disorder and over 13 million healthy individuals showed that children of mothers younger than 20 years had a 23% increased risk for bipolar disorder vs. those whose parents were aged 25-29 years. For participants whose mothers were aged 35-39 years, there was a 10% increased risk for bipolar disorder, which rose to 20% if the mother was aged 40 or older.

Having a father younger than 20 years conferred a 29% increased risk for bipolar disorder, which was the same increase in risk found in individuals whose fathers were aged 45 years or older.

These findings, which are an update of data published in the journal European Pharmacology, were presented at the 35th European College of Neuropsychopharmacology (ECNP) Congress.
 

Fourteen studies included

Previous studies have suggested that parental age at birth is a risk factor for several psychiatric disorders in offspring, including bipolar disorder, and that advanced parental age, specifically, is associated with earlier onset schizophrenia.

To investigate further, the current researchers conducted a systematic review and meta-analysis, searching the PubMed/MEDLINE, EMBASE, Scopus, and PsychINFO databases for relevant studies published to Dec. 1, 2021.

From 712 studies initially identified, 16 met all the inclusion criteria and 14 were included in the quantitative analysis.

Five studies reported only paternal age and risk for bipolar disorder in their offspring, one included just maternal age, and eight reported both maternal and paternal age in relation to the risk for offspring bipolar disorder.

Individuals with a history of any psychiatric disorders were excluded, leaving a total of 13.4 million individuals without bipolar disorder and 217,089 who had received a diagnosis for the disorder.

The investigators also corrected for both socioeconomic status and, when assessing the impact of maternal or paternal age at birth, corrected for the age of the other parent. However, they were unable to correct for the number of children in a family.

Results after stratifying maternal and paternal age showed that, compared with those born to parents aged 25-29 years, there was an increased risk for bipolar disorder in the offspring of both fathers and mothers younger than 20 years of age, with adjusted odds ratios of 1.29 (95% confidence interval, 1.13-1.48) and 1.23 (95% CI, 1.14-1.33), respectively.

Compared with those aged 25-29 years, there was also an increased risk for bipolar disorder in children born to mothers aged 35-39 years (adjusted OR, 1.1; 95% CI, 1.01-1.19) and aged 40 or older (OR, 1.2; 95% CI, 1.02-1.40).

Among fathers, there was increased risk for offspring bipolar disorder in those aged 45 or older vs. those aged 25-29 years (adjusted OR, 1.29; 95% CI, 1.15-1.46).
 

Several hypotheses

There are several hypotheses that could explain the results, lead study author Giovanna Fico, MD, bipolar and depressive disorders unit, Hospital Clínic Barcelona, told this news organization.

In older age, it may be “more related to genetic or epigenetic modification, especially in fathers,” Dr. Fico said. “Some studies have shown that there are de novo mutations in the germ lines, which increase the risk of several diseases, including schizophrenia.”

In younger individuals, there could be a “mixed effect between sociocultural factors, such as substance abuse, low educational status,” and other issues, Dr. Fico noted.

Moreover, as bipolar disorder onset can be as late as 30 years of age, the younger group could include “undiagnosed patients with bipolar disorder, which would increase the risk” of the disease in their offspring, she added.

Dr. Fico noted the investigators are now planning on studying the impact of environmental factors such as pollution, climate change, and urbanization on risk for bipolar disorder, with the aim of being better able to inform parents or to develop prevention strategies.

Psychoeducation is “very common for infertility, birth defects, and Down syndrome, but it’s not so common for psychiatric disorders because we need more data. But I think it’s important that parents know they have an increased risk,” she said.

Nevertheless, “We must stress that this risk is moderate, and it must be kept in perspective,” Dr. Fico said in a news release.
 

‘Exciting’ questions raised

The study “raises several exciting research questions, including the possibility of early prevention and intervention,” Maj Vinberg, MD, PhD, clinical professor, department of clinical medicine, University of Copenhagen, said in the release.

She said she agrees there are likely to be different factors at play at different ages, with the risk for bipolar disorder associated with younger-age parenthood more likely to be related to socioeconomic status.

For older parents, “there has been a lot of speculation around the father’s age especially, which everybody thought didn’t matter,” said Dr. Vinberg, who was not involved with the research.

“But you might have some epigenetic changes as you grow older that might transfer into the next generation,” given that there is 20 years of additional exposure to potential epigenetic changes between a man aged 25 years and one aged 45 years, she noted.

Dr. Vinberg also highlighted that there could be cases of undiagnosed bipolar disorder among the younger parents, and she noted that “men with bipolar disorder tend to have more children,” particularly during manic phases.

She explained that if someone were to get divorced at 35 years of age, then have a new manic episode at 45 “and have a new wife and children, I don’t know whether it’s possible to correct for that.”

The research is supported by a fellowship from “la Caixa” Foundation. The investigators have reported no relevant financial relationships. Dr. Vinberg reported having relationships with Lundbeck and Janssen.

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

VIENNA – Individuals born to younger or older parents are at increased risk of developing bipolar disorder, new research suggests.

Results from a meta-analysis of more than 210,000 patients with bipolar disorder and over 13 million healthy individuals showed that children of mothers younger than 20 years had a 23% increased risk for bipolar disorder vs. those whose parents were aged 25-29 years. For participants whose mothers were aged 35-39 years, there was a 10% increased risk for bipolar disorder, which rose to 20% if the mother was aged 40 or older.

Having a father younger than 20 years conferred a 29% increased risk for bipolar disorder, which was the same increase in risk found in individuals whose fathers were aged 45 years or older.

These findings, which are an update of data published in the journal European Pharmacology, were presented at the 35th European College of Neuropsychopharmacology (ECNP) Congress.
 

Fourteen studies included

Previous studies have suggested that parental age at birth is a risk factor for several psychiatric disorders in offspring, including bipolar disorder, and that advanced parental age, specifically, is associated with earlier onset schizophrenia.

To investigate further, the current researchers conducted a systematic review and meta-analysis, searching the PubMed/MEDLINE, EMBASE, Scopus, and PsychINFO databases for relevant studies published to Dec. 1, 2021.

From 712 studies initially identified, 16 met all the inclusion criteria and 14 were included in the quantitative analysis.

Five studies reported only paternal age and risk for bipolar disorder in their offspring, one included just maternal age, and eight reported both maternal and paternal age in relation to the risk for offspring bipolar disorder.

Individuals with a history of any psychiatric disorders were excluded, leaving a total of 13.4 million individuals without bipolar disorder and 217,089 who had received a diagnosis for the disorder.

The investigators also corrected for both socioeconomic status and, when assessing the impact of maternal or paternal age at birth, corrected for the age of the other parent. However, they were unable to correct for the number of children in a family.

Results after stratifying maternal and paternal age showed that, compared with those born to parents aged 25-29 years, there was an increased risk for bipolar disorder in the offspring of both fathers and mothers younger than 20 years of age, with adjusted odds ratios of 1.29 (95% confidence interval, 1.13-1.48) and 1.23 (95% CI, 1.14-1.33), respectively.

Compared with those aged 25-29 years, there was also an increased risk for bipolar disorder in children born to mothers aged 35-39 years (adjusted OR, 1.1; 95% CI, 1.01-1.19) and aged 40 or older (OR, 1.2; 95% CI, 1.02-1.40).

Among fathers, there was increased risk for offspring bipolar disorder in those aged 45 or older vs. those aged 25-29 years (adjusted OR, 1.29; 95% CI, 1.15-1.46).
 

Several hypotheses

There are several hypotheses that could explain the results, lead study author Giovanna Fico, MD, bipolar and depressive disorders unit, Hospital Clínic Barcelona, told this news organization.

In older age, it may be “more related to genetic or epigenetic modification, especially in fathers,” Dr. Fico said. “Some studies have shown that there are de novo mutations in the germ lines, which increase the risk of several diseases, including schizophrenia.”

In younger individuals, there could be a “mixed effect between sociocultural factors, such as substance abuse, low educational status,” and other issues, Dr. Fico noted.

Moreover, as bipolar disorder onset can be as late as 30 years of age, the younger group could include “undiagnosed patients with bipolar disorder, which would increase the risk” of the disease in their offspring, she added.

Dr. Fico noted the investigators are now planning on studying the impact of environmental factors such as pollution, climate change, and urbanization on risk for bipolar disorder, with the aim of being better able to inform parents or to develop prevention strategies.

Psychoeducation is “very common for infertility, birth defects, and Down syndrome, but it’s not so common for psychiatric disorders because we need more data. But I think it’s important that parents know they have an increased risk,” she said.

Nevertheless, “We must stress that this risk is moderate, and it must be kept in perspective,” Dr. Fico said in a news release.
 

‘Exciting’ questions raised

The study “raises several exciting research questions, including the possibility of early prevention and intervention,” Maj Vinberg, MD, PhD, clinical professor, department of clinical medicine, University of Copenhagen, said in the release.

She said she agrees there are likely to be different factors at play at different ages, with the risk for bipolar disorder associated with younger-age parenthood more likely to be related to socioeconomic status.

For older parents, “there has been a lot of speculation around the father’s age especially, which everybody thought didn’t matter,” said Dr. Vinberg, who was not involved with the research.

“But you might have some epigenetic changes as you grow older that might transfer into the next generation,” given that there is 20 years of additional exposure to potential epigenetic changes between a man aged 25 years and one aged 45 years, she noted.

Dr. Vinberg also highlighted that there could be cases of undiagnosed bipolar disorder among the younger parents, and she noted that “men with bipolar disorder tend to have more children,” particularly during manic phases.

She explained that if someone were to get divorced at 35 years of age, then have a new manic episode at 45 “and have a new wife and children, I don’t know whether it’s possible to correct for that.”

The research is supported by a fellowship from “la Caixa” Foundation. The investigators have reported no relevant financial relationships. Dr. Vinberg reported having relationships with Lundbeck and Janssen.

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

“How did we miss out on that?” “What?” my physician friend replied as we stood in line at the coffee cart. “Root cause. I mean, we invented this idea and now all these naturopaths and functional medicine quacks are gettin’ rich off it.” “Take it easy,” he says. “Just order a coffee.”

It’s hard not to be indignant. I had a morning clinic with three patients insisting I find the “root cause” of their problem. Now, if one had flagellate dermatitis after eating Asian mushroom soup, I’d have said “Root cause? Shiitake mushrooms!” and walked out like Costanza in Seinfeld, “All right, that’s it for me! Be good everybody!”

Alas no. They had perioral dermatitis, alopecia areata, eczema – no satisfying “roots” for walk-off answers.

There is a universal desire to find the proximal cause for problems. Patients often want to know it so that we address the root of their trouble and not just cut off the branches. This is deeply gratifying for those who want not only to know why, but also to have agency in how to control their disease. For example, if they believe the root cause of perioral dermatitis was excess yeast, then eating a “candida diet’’ should do the trick! Food sensitivities, hormones, and heavy metals round out the top suspects that root cause patients want to talk about.

Of course, patients have been asking about this for a long time, but lately, the root cause visit seems to be on trend. Check out any hip primary care start-up such as One Medical or any hot direct-to-consumer virtual offering such as ParsleyHealth and you will see root-cause everywhere. Our patients are expecting us to address it, or it seems they will find someone cooler who will.

Yet, it wasn’t the slick marketing team at ParsleyHeath who invented the “root cause doctor visit.” We did. It’s an idea that started with our Greek physician ancestors. Breaking from the diviners and priests, we were the first “naturalists” positing that there was a natural, not a divine cause for illness. The cardinal concept in the Hippocratic Corpus was that health was an equilibrium and illness an imbalance. They didn’t have dehydroepiandrosterone tests or mercury levels, but did have bodily fluids. Yellow bile, black bile, blood, and phlegm, were the root of all root causes. A physician simply had to identify which was in excess or deficient and fix that to cure the disease. Interestingly, the word “diagnosis” appears only once in the Corpus. The word “Diagignoskein” appears occasionally but this describes studying thoroughly, not naming a diagnosis as we understand it.

Advances in chemistry in the 17th century meant physicians could add new theories, and new root causes. Now alkaline or other chemical elixirs were added to cure at the source. Since there was no verifiable evidence to prove causes, theories were adopted to provide some rational direction to treatment. In the 18th century, physicians such as Dr. Benjamin Rush, one of the original faculty at the University of Pennsylvania school of medicine, taught that spasms of the arteries were the root cause of illnesses. “Heroic” treatments such as extreme bloodletting were the cure. (Note, those patients who survived us kept coming back to us for more).

Scientific knowledge and diagnostic technologies led to more and more complex and abstruse causes. Yet, as we became more precise and effective, our explanations became less satisfying to our patients. I can diagnose and readily treat perioral dermatitis, yet I’m hard pressed to give an answer to its root cause. “Root cause? Yes. Just apply this pimecrolimus cream for a couple of weeks and it’ll be better! All right, that’s it for me! Be good everybody!”

You’ll have to do better, George.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]

“How did we miss out on that?” “What?” my physician friend replied as we stood in line at the coffee cart. “Root cause. I mean, we invented this idea and now all these naturopaths and functional medicine quacks are gettin’ rich off it.” “Take it easy,” he says. “Just order a coffee.”

It’s hard not to be indignant. I had a morning clinic with three patients insisting I find the “root cause” of their problem. Now, if one had flagellate dermatitis after eating Asian mushroom soup, I’d have said “Root cause? Shiitake mushrooms!” and walked out like Costanza in Seinfeld, “All right, that’s it for me! Be good everybody!”

Alas no. They had perioral dermatitis, alopecia areata, eczema – no satisfying “roots” for walk-off answers.

There is a universal desire to find the proximal cause for problems. Patients often want to know it so that we address the root of their trouble and not just cut off the branches. This is deeply gratifying for those who want not only to know why, but also to have agency in how to control their disease. For example, if they believe the root cause of perioral dermatitis was excess yeast, then eating a “candida diet’’ should do the trick! Food sensitivities, hormones, and heavy metals round out the top suspects that root cause patients want to talk about.

Of course, patients have been asking about this for a long time, but lately, the root cause visit seems to be on trend. Check out any hip primary care start-up such as One Medical or any hot direct-to-consumer virtual offering such as ParsleyHealth and you will see root-cause everywhere. Our patients are expecting us to address it, or it seems they will find someone cooler who will.

Yet, it wasn’t the slick marketing team at ParsleyHeath who invented the “root cause doctor visit.” We did. It’s an idea that started with our Greek physician ancestors. Breaking from the diviners and priests, we were the first “naturalists” positing that there was a natural, not a divine cause for illness. The cardinal concept in the Hippocratic Corpus was that health was an equilibrium and illness an imbalance. They didn’t have dehydroepiandrosterone tests or mercury levels, but did have bodily fluids. Yellow bile, black bile, blood, and phlegm, were the root of all root causes. A physician simply had to identify which was in excess or deficient and fix that to cure the disease. Interestingly, the word “diagnosis” appears only once in the Corpus. The word “Diagignoskein” appears occasionally but this describes studying thoroughly, not naming a diagnosis as we understand it.

Advances in chemistry in the 17th century meant physicians could add new theories, and new root causes. Now alkaline or other chemical elixirs were added to cure at the source. Since there was no verifiable evidence to prove causes, theories were adopted to provide some rational direction to treatment. In the 18th century, physicians such as Dr. Benjamin Rush, one of the original faculty at the University of Pennsylvania school of medicine, taught that spasms of the arteries were the root cause of illnesses. “Heroic” treatments such as extreme bloodletting were the cure. (Note, those patients who survived us kept coming back to us for more).

Scientific knowledge and diagnostic technologies led to more and more complex and abstruse causes. Yet, as we became more precise and effective, our explanations became less satisfying to our patients. I can diagnose and readily treat perioral dermatitis, yet I’m hard pressed to give an answer to its root cause. “Root cause? Yes. Just apply this pimecrolimus cream for a couple of weeks and it’ll be better! All right, that’s it for me! Be good everybody!”

You’ll have to do better, George.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]

“How did we miss out on that?” “What?” my physician friend replied as we stood in line at the coffee cart. “Root cause. I mean, we invented this idea and now all these naturopaths and functional medicine quacks are gettin’ rich off it.” “Take it easy,” he says. “Just order a coffee.”

It’s hard not to be indignant. I had a morning clinic with three patients insisting I find the “root cause” of their problem. Now, if one had flagellate dermatitis after eating Asian mushroom soup, I’d have said “Root cause? Shiitake mushrooms!” and walked out like Costanza in Seinfeld, “All right, that’s it for me! Be good everybody!”

Alas no. They had perioral dermatitis, alopecia areata, eczema – no satisfying “roots” for walk-off answers.

There is a universal desire to find the proximal cause for problems. Patients often want to know it so that we address the root of their trouble and not just cut off the branches. This is deeply gratifying for those who want not only to know why, but also to have agency in how to control their disease. For example, if they believe the root cause of perioral dermatitis was excess yeast, then eating a “candida diet’’ should do the trick! Food sensitivities, hormones, and heavy metals round out the top suspects that root cause patients want to talk about.

Of course, patients have been asking about this for a long time, but lately, the root cause visit seems to be on trend. Check out any hip primary care start-up such as One Medical or any hot direct-to-consumer virtual offering such as ParsleyHealth and you will see root-cause everywhere. Our patients are expecting us to address it, or it seems they will find someone cooler who will.

Yet, it wasn’t the slick marketing team at ParsleyHeath who invented the “root cause doctor visit.” We did. It’s an idea that started with our Greek physician ancestors. Breaking from the diviners and priests, we were the first “naturalists” positing that there was a natural, not a divine cause for illness. The cardinal concept in the Hippocratic Corpus was that health was an equilibrium and illness an imbalance. They didn’t have dehydroepiandrosterone tests or mercury levels, but did have bodily fluids. Yellow bile, black bile, blood, and phlegm, were the root of all root causes. A physician simply had to identify which was in excess or deficient and fix that to cure the disease. Interestingly, the word “diagnosis” appears only once in the Corpus. The word “Diagignoskein” appears occasionally but this describes studying thoroughly, not naming a diagnosis as we understand it.

Advances in chemistry in the 17th century meant physicians could add new theories, and new root causes. Now alkaline or other chemical elixirs were added to cure at the source. Since there was no verifiable evidence to prove causes, theories were adopted to provide some rational direction to treatment. In the 18th century, physicians such as Dr. Benjamin Rush, one of the original faculty at the University of Pennsylvania school of medicine, taught that spasms of the arteries were the root cause of illnesses. “Heroic” treatments such as extreme bloodletting were the cure. (Note, those patients who survived us kept coming back to us for more).

Scientific knowledge and diagnostic technologies led to more and more complex and abstruse causes. Yet, as we became more precise and effective, our explanations became less satisfying to our patients. I can diagnose and readily treat perioral dermatitis, yet I’m hard pressed to give an answer to its root cause. “Root cause? Yes. Just apply this pimecrolimus cream for a couple of weeks and it’ll be better! All right, that’s it for me! Be good everybody!”

You’ll have to do better, George.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]

A stuffed animal, aromatherapy, a night light. A kit containing these and other items can help children in foster care who have experienced trauma sleep more soundly, a critical step in helping them cope with their emotional distress. 

In a new study, researchers at the Children’s Hospital of Philadelphia reported that sleep kits specially tailored to foster children appeared to be helpful in most cases. The kits can be distributed by pediatricians in the office or clinic setting.

“Children who have experienced trauma can have issues with behavior, it can impact their school, and they have difficulties sleeping,” said Kristine Fortin, MD, MPH, director of the fostering health program at Safe Place: Center for Child Protection and Health at CHOP. “I thought, what could a pediatrician do in the office in one visit to help children with sleep?”

Dr. Fortin and colleagues designed sleep kits for both younger children and adolescents.

The version for teenagers contained a sound machine, aromatherapy spray, and a sleep mask. The kits for younger children contained matching stuffed toys to share with someone they felt connected to, and a rechargeable night-light. All kits included written materials about sleep hygiene, a journal, and directions for downloading a free age-appropriate relaxation app for belly breathing or a PTSD Coach app from the Department of Veterans Affairs to manage symptoms of trauma.

In a pilot study presented at the annual meeting of the American Academy of Pediatrics, Dr. Fortin and colleagues surveyed caregivers in foster homes about their use of the kits.

Of the 20 foster parents who responded to the survey, 11 said the kits helped “very much,” 5 others reported they helped “somewhat,” another 2 reported no improvements in sleep, and 2 said they didn’t know the effect. The children for whom results were unknown moved from the home without the sleep kit or had difficulties communicating with the foster parents, resulting in incomplete assessment, according to the researchers. 

Night-lights were used most in the kits, followed by the stuffed toys, sound machines, and sleep journals.

Dr. Fortin said existing resources like sleep therapy or medication can be costly or difficult to find, and many pediatricians don’t have enough time during wellness visits to address symptoms like sleep deprivation. She said the sleep kits could be an alternative to other forms of sleep therapy. “If these sleep kits were effective, and could really help them sleep, then maybe less children would need something like medication.”

Dr. Fortin said the kits her group has designed are tailored specifically for children with symptoms of trauma, or with difficult emotions associated with foster care.

“We’ve tried to design something that can be really practical and easy to use in a pediatric visit, where there’s a lot of written information that can be discussed with the child and their family,” Dr. Fortin said.

She added that she would like to see clinicians give out the sleep kits during in-office visits.

“These sleep issues are common in foster children,” she said. “We felt it was important to do an intervention.”

Kristina Lenker, PhD, a sleep psychologist at Penn State Health, Hershey, said children in foster care often struggle with falling or staying asleep, an inability to sleep alone, nightmares, and bed wetting.

“Sleep kits can be particularly helpful for these children, given how they can help caregivers to provide a safe sleep environment and predictable routine, and send messages of safety and comfort at bedtime, with tangible objects, and enable children to feel a sense of control,” she said.

Charitable organizations like Pajama Program and Sleeping Children Around the World provide sleep kits to children from underserved backgrounds. But Candice Alfano, PhD, director of the University of Houston’s Sleep and Anxiety Center of Houston, said the CHOP kits are the first to specifically target sleeping difficulties in foster children.

“Sleep is a largely neglected yet essential area of health, development, and well-being in this highly-vulnerable population of youth, so I am very excited to see this work being done,” Dr. Alfano said in an interview.

Dr. Fortin and Dr. Lenker reported no relevant financial relationships.

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

A stuffed animal, aromatherapy, a night light. A kit containing these and other items can help children in foster care who have experienced trauma sleep more soundly, a critical step in helping them cope with their emotional distress. 

In a new study, researchers at the Children’s Hospital of Philadelphia reported that sleep kits specially tailored to foster children appeared to be helpful in most cases. The kits can be distributed by pediatricians in the office or clinic setting.

“Children who have experienced trauma can have issues with behavior, it can impact their school, and they have difficulties sleeping,” said Kristine Fortin, MD, MPH, director of the fostering health program at Safe Place: Center for Child Protection and Health at CHOP. “I thought, what could a pediatrician do in the office in one visit to help children with sleep?”

Dr. Fortin and colleagues designed sleep kits for both younger children and adolescents.

The version for teenagers contained a sound machine, aromatherapy spray, and a sleep mask. The kits for younger children contained matching stuffed toys to share with someone they felt connected to, and a rechargeable night-light. All kits included written materials about sleep hygiene, a journal, and directions for downloading a free age-appropriate relaxation app for belly breathing or a PTSD Coach app from the Department of Veterans Affairs to manage symptoms of trauma.

In a pilot study presented at the annual meeting of the American Academy of Pediatrics, Dr. Fortin and colleagues surveyed caregivers in foster homes about their use of the kits.

Of the 20 foster parents who responded to the survey, 11 said the kits helped “very much,” 5 others reported they helped “somewhat,” another 2 reported no improvements in sleep, and 2 said they didn’t know the effect. The children for whom results were unknown moved from the home without the sleep kit or had difficulties communicating with the foster parents, resulting in incomplete assessment, according to the researchers. 

Night-lights were used most in the kits, followed by the stuffed toys, sound machines, and sleep journals.

Dr. Fortin said existing resources like sleep therapy or medication can be costly or difficult to find, and many pediatricians don’t have enough time during wellness visits to address symptoms like sleep deprivation. She said the sleep kits could be an alternative to other forms of sleep therapy. “If these sleep kits were effective, and could really help them sleep, then maybe less children would need something like medication.”

Dr. Fortin said the kits her group has designed are tailored specifically for children with symptoms of trauma, or with difficult emotions associated with foster care.

“We’ve tried to design something that can be really practical and easy to use in a pediatric visit, where there’s a lot of written information that can be discussed with the child and their family,” Dr. Fortin said.

She added that she would like to see clinicians give out the sleep kits during in-office visits.

“These sleep issues are common in foster children,” she said. “We felt it was important to do an intervention.”

Kristina Lenker, PhD, a sleep psychologist at Penn State Health, Hershey, said children in foster care often struggle with falling or staying asleep, an inability to sleep alone, nightmares, and bed wetting.

“Sleep kits can be particularly helpful for these children, given how they can help caregivers to provide a safe sleep environment and predictable routine, and send messages of safety and comfort at bedtime, with tangible objects, and enable children to feel a sense of control,” she said.

Charitable organizations like Pajama Program and Sleeping Children Around the World provide sleep kits to children from underserved backgrounds. But Candice Alfano, PhD, director of the University of Houston’s Sleep and Anxiety Center of Houston, said the CHOP kits are the first to specifically target sleeping difficulties in foster children.

“Sleep is a largely neglected yet essential area of health, development, and well-being in this highly-vulnerable population of youth, so I am very excited to see this work being done,” Dr. Alfano said in an interview.

Dr. Fortin and Dr. Lenker reported no relevant financial relationships.

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

A stuffed animal, aromatherapy, a night light. A kit containing these and other items can help children in foster care who have experienced trauma sleep more soundly, a critical step in helping them cope with their emotional distress. 

In a new study, researchers at the Children’s Hospital of Philadelphia reported that sleep kits specially tailored to foster children appeared to be helpful in most cases. The kits can be distributed by pediatricians in the office or clinic setting.

“Children who have experienced trauma can have issues with behavior, it can impact their school, and they have difficulties sleeping,” said Kristine Fortin, MD, MPH, director of the fostering health program at Safe Place: Center for Child Protection and Health at CHOP. “I thought, what could a pediatrician do in the office in one visit to help children with sleep?”

Dr. Fortin and colleagues designed sleep kits for both younger children and adolescents.

The version for teenagers contained a sound machine, aromatherapy spray, and a sleep mask. The kits for younger children contained matching stuffed toys to share with someone they felt connected to, and a rechargeable night-light. All kits included written materials about sleep hygiene, a journal, and directions for downloading a free age-appropriate relaxation app for belly breathing or a PTSD Coach app from the Department of Veterans Affairs to manage symptoms of trauma.

In a pilot study presented at the annual meeting of the American Academy of Pediatrics, Dr. Fortin and colleagues surveyed caregivers in foster homes about their use of the kits.

Of the 20 foster parents who responded to the survey, 11 said the kits helped “very much,” 5 others reported they helped “somewhat,” another 2 reported no improvements in sleep, and 2 said they didn’t know the effect. The children for whom results were unknown moved from the home without the sleep kit or had difficulties communicating with the foster parents, resulting in incomplete assessment, according to the researchers. 

Night-lights were used most in the kits, followed by the stuffed toys, sound machines, and sleep journals.

Dr. Fortin said existing resources like sleep therapy or medication can be costly or difficult to find, and many pediatricians don’t have enough time during wellness visits to address symptoms like sleep deprivation. She said the sleep kits could be an alternative to other forms of sleep therapy. “If these sleep kits were effective, and could really help them sleep, then maybe less children would need something like medication.”

Dr. Fortin said the kits her group has designed are tailored specifically for children with symptoms of trauma, or with difficult emotions associated with foster care.

“We’ve tried to design something that can be really practical and easy to use in a pediatric visit, where there’s a lot of written information that can be discussed with the child and their family,” Dr. Fortin said.

She added that she would like to see clinicians give out the sleep kits during in-office visits.

“These sleep issues are common in foster children,” she said. “We felt it was important to do an intervention.”

Kristina Lenker, PhD, a sleep psychologist at Penn State Health, Hershey, said children in foster care often struggle with falling or staying asleep, an inability to sleep alone, nightmares, and bed wetting.

“Sleep kits can be particularly helpful for these children, given how they can help caregivers to provide a safe sleep environment and predictable routine, and send messages of safety and comfort at bedtime, with tangible objects, and enable children to feel a sense of control,” she said.

Charitable organizations like Pajama Program and Sleeping Children Around the World provide sleep kits to children from underserved backgrounds. But Candice Alfano, PhD, director of the University of Houston’s Sleep and Anxiety Center of Houston, said the CHOP kits are the first to specifically target sleeping difficulties in foster children.

“Sleep is a largely neglected yet essential area of health, development, and well-being in this highly-vulnerable population of youth, so I am very excited to see this work being done,” Dr. Alfano said in an interview.

Dr. Fortin and Dr. Lenker reported no relevant financial relationships.

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

Contrary to some prior studies, new research suggests that a healthy diet, including the Mediterranean diet, does not reduce dementia risk.

After adjusting for relevant demographic and other lifestyle measures, there was no association between adherence to healthy dietary advice or the Mediterranean diet on the future risk of dementia or amyloid-beta (Abeta) accumulation.

OksanaKiian/Getty Images

“While our study does not rule out a possible association between diet and dementia, we did not find a link in our study, which had a long follow-up period, included younger participants than some other studies and did not require people to remember what foods they had eaten regularly years before,” study investigator Isabelle Glans, MD, of Lund (Sweden) University, said in a news release.

The findings were published online in Neurology.
 

No risk reduction

Several studies have investigated how dietary habits affect dementia risk, with inconsistent results.

The new findings are based on 28,025 adults (61% women; mean age, 58 years at baseline) who were free of dementia at baseline and were followed over a 20-year period as part of the Swedish Malmö Diet and Cancer Study. Dietary habits were assessed with a 7-day food diary, detailed food frequency questionnaire, and in-person interview.

During follow-up, 1,943 individuals (6.9%) developed dementia.

Compared with those who did not develop dementia, those who did develop dementia during follow-up were older and had a lower level of education and more cardiovascular risk factors and comorbidities at baseline.

Individuals who adhered to conventional healthy dietary recommendations did not have a lower risk of developing all-cause dementia (hazard ratio comparing worst with best adherence, 0.93; 95% confidence interval, 0.81-1.08), Alzheimer’s disease (HR, 1.03; 95% CI, 0.85-1.23) or vascular dementia (HR, 0.93; 95% CI, 0.69-1.26).

Adherence to the modified Mediterranean diet also did not appear to lower the risk of all-cause dementia (HR, 0.93; 95% CI, 0.75-1.15), Alzheimer’s disease (HR, 0.90; 95% CI, 0.68-1.19), or vascular dementia (HR, 1.00; 95% CI, 0.65-1.55).

There was also no significant association between diet and Alzheimer’s disease–related pathology, as measured by cerebrospinal fluid analysis of Abeta42 in a subgroup of 738 participants. Various sensitivity analyses yielded similar results.
 

Diet still matters

The authors of an accompanying editorial noted that diet as a “singular factor may not have a strong enough effect on cognition, but is more likely to be considered as one factor embedded with various others, the sum of which may influence the course of cognitive function (diet, regular exercise, vascular risk factor control, avoiding cigarette smoking, drinking alcohol in moderation, etc).

“Diet should not be forgotten and it still matters” but should be regarded as “one part of a multidomain intervention with respect to cognitive performance,” wrote Nils Peters, MD, with the University of Basel (Switzerland), and Benedetta Nacmias, PhD, with the University of Florence (Italy)).

“Key questions that remain include how to provide evidence for promoting the implications of dietary habits on cognition? Overall, dietary strategies will most likely be implicated either in order to reduce the increasing number of older subjects with dementia, or to extend healthy life expectancy, or both,” Dr. Peters and Dr. Nacmias said.

The study had no commercial funding. Dr. Glans, Dr. Peters, and Dr. Nacmias disclosed no relevant financial relationships.

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

Contrary to some prior studies, new research suggests that a healthy diet, including the Mediterranean diet, does not reduce dementia risk.

After adjusting for relevant demographic and other lifestyle measures, there was no association between adherence to healthy dietary advice or the Mediterranean diet on the future risk of dementia or amyloid-beta (Abeta) accumulation.

OksanaKiian/Getty Images

“While our study does not rule out a possible association between diet and dementia, we did not find a link in our study, which had a long follow-up period, included younger participants than some other studies and did not require people to remember what foods they had eaten regularly years before,” study investigator Isabelle Glans, MD, of Lund (Sweden) University, said in a news release.

The findings were published online in Neurology.
 

No risk reduction

Several studies have investigated how dietary habits affect dementia risk, with inconsistent results.

The new findings are based on 28,025 adults (61% women; mean age, 58 years at baseline) who were free of dementia at baseline and were followed over a 20-year period as part of the Swedish Malmö Diet and Cancer Study. Dietary habits were assessed with a 7-day food diary, detailed food frequency questionnaire, and in-person interview.

During follow-up, 1,943 individuals (6.9%) developed dementia.

Compared with those who did not develop dementia, those who did develop dementia during follow-up were older and had a lower level of education and more cardiovascular risk factors and comorbidities at baseline.

Individuals who adhered to conventional healthy dietary recommendations did not have a lower risk of developing all-cause dementia (hazard ratio comparing worst with best adherence, 0.93; 95% confidence interval, 0.81-1.08), Alzheimer’s disease (HR, 1.03; 95% CI, 0.85-1.23) or vascular dementia (HR, 0.93; 95% CI, 0.69-1.26).

Adherence to the modified Mediterranean diet also did not appear to lower the risk of all-cause dementia (HR, 0.93; 95% CI, 0.75-1.15), Alzheimer’s disease (HR, 0.90; 95% CI, 0.68-1.19), or vascular dementia (HR, 1.00; 95% CI, 0.65-1.55).

There was also no significant association between diet and Alzheimer’s disease–related pathology, as measured by cerebrospinal fluid analysis of Abeta42 in a subgroup of 738 participants. Various sensitivity analyses yielded similar results.
 

Diet still matters

The authors of an accompanying editorial noted that diet as a “singular factor may not have a strong enough effect on cognition, but is more likely to be considered as one factor embedded with various others, the sum of which may influence the course of cognitive function (diet, regular exercise, vascular risk factor control, avoiding cigarette smoking, drinking alcohol in moderation, etc).

“Diet should not be forgotten and it still matters” but should be regarded as “one part of a multidomain intervention with respect to cognitive performance,” wrote Nils Peters, MD, with the University of Basel (Switzerland), and Benedetta Nacmias, PhD, with the University of Florence (Italy)).

“Key questions that remain include how to provide evidence for promoting the implications of dietary habits on cognition? Overall, dietary strategies will most likely be implicated either in order to reduce the increasing number of older subjects with dementia, or to extend healthy life expectancy, or both,” Dr. Peters and Dr. Nacmias said.

The study had no commercial funding. Dr. Glans, Dr. Peters, and Dr. Nacmias disclosed no relevant financial relationships.

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

Contrary to some prior studies, new research suggests that a healthy diet, including the Mediterranean diet, does not reduce dementia risk.

After adjusting for relevant demographic and other lifestyle measures, there was no association between adherence to healthy dietary advice or the Mediterranean diet on the future risk of dementia or amyloid-beta (Abeta) accumulation.

OksanaKiian/Getty Images

“While our study does not rule out a possible association between diet and dementia, we did not find a link in our study, which had a long follow-up period, included younger participants than some other studies and did not require people to remember what foods they had eaten regularly years before,” study investigator Isabelle Glans, MD, of Lund (Sweden) University, said in a news release.

The findings were published online in Neurology.
 

No risk reduction

Several studies have investigated how dietary habits affect dementia risk, with inconsistent results.

The new findings are based on 28,025 adults (61% women; mean age, 58 years at baseline) who were free of dementia at baseline and were followed over a 20-year period as part of the Swedish Malmö Diet and Cancer Study. Dietary habits were assessed with a 7-day food diary, detailed food frequency questionnaire, and in-person interview.

During follow-up, 1,943 individuals (6.9%) developed dementia.

Compared with those who did not develop dementia, those who did develop dementia during follow-up were older and had a lower level of education and more cardiovascular risk factors and comorbidities at baseline.

Individuals who adhered to conventional healthy dietary recommendations did not have a lower risk of developing all-cause dementia (hazard ratio comparing worst with best adherence, 0.93; 95% confidence interval, 0.81-1.08), Alzheimer’s disease (HR, 1.03; 95% CI, 0.85-1.23) or vascular dementia (HR, 0.93; 95% CI, 0.69-1.26).

Adherence to the modified Mediterranean diet also did not appear to lower the risk of all-cause dementia (HR, 0.93; 95% CI, 0.75-1.15), Alzheimer’s disease (HR, 0.90; 95% CI, 0.68-1.19), or vascular dementia (HR, 1.00; 95% CI, 0.65-1.55).

There was also no significant association between diet and Alzheimer’s disease–related pathology, as measured by cerebrospinal fluid analysis of Abeta42 in a subgroup of 738 participants. Various sensitivity analyses yielded similar results.
 

Diet still matters

The authors of an accompanying editorial noted that diet as a “singular factor may not have a strong enough effect on cognition, but is more likely to be considered as one factor embedded with various others, the sum of which may influence the course of cognitive function (diet, regular exercise, vascular risk factor control, avoiding cigarette smoking, drinking alcohol in moderation, etc).

“Diet should not be forgotten and it still matters” but should be regarded as “one part of a multidomain intervention with respect to cognitive performance,” wrote Nils Peters, MD, with the University of Basel (Switzerland), and Benedetta Nacmias, PhD, with the University of Florence (Italy)).

“Key questions that remain include how to provide evidence for promoting the implications of dietary habits on cognition? Overall, dietary strategies will most likely be implicated either in order to reduce the increasing number of older subjects with dementia, or to extend healthy life expectancy, or both,” Dr. Peters and Dr. Nacmias said.

The study had no commercial funding. Dr. Glans, Dr. Peters, and Dr. Nacmias disclosed no relevant financial relationships.

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