Psychiatry Month in Review: March 2025

March brought important developments in mental health research. A meta-analysis confirmed that GLP-1 receptor agonists do not increase the risk of suicide or self-harm, easing concerns around their safety in managing diabetes and obesity. Meanwhile, a study on daily discrimination highlighted its strong link to depression and anxiety, with marginalized groups facing greater risks. Both studies underscore the need for ongoing research and more targeted care in mental health treatment.

This month in review features US Food and Drug Administration (FDA) updates, phase 2 and 3 trials to look out for, and other research published in the psychiatry field this month.

FDA Updates in Psychiatry

PharmaTher Receives New Early June FDA Goal Date for Ketamine

PharmaTher announced a new FDA goal date of June 4, 2025, for ketamine approval, targeting anesthesia, sedation, pain, mental health, and neurological conditions. This follows an Amendment Acknowledgment Letter after a complete response letter in October 2024, requesting updates on drug substances, manufacturing, and microbiology.

PharmaTher aims to address the ongoing ketamine shortage, which has fueled the use of compounded products with safety concerns. If approved, compounded ketamine may face a phase-out period similar to Wegovy and Ozempic.

Phase 2, 3 Trials to Look Out For

Methylone Shows Rapid PTSD Symptom Improvement in Phase 2 IMPACT-1 Trial

TSND-201 (methylone) met its primary endpoint in the phase 2 IMPACT-1 trial, showing rapid and significant PTSD symptom improvement. By day 64, CAPS-5 scores improved notably, with effects emerging as early as day 10.

Secondary endpoints, including response, remission, and loss of PTSD diagnosis, also showed significant gains. The treatment was well-tolerated, with most adverse events occurring on dosing days. Transcend Therapeutics plans to collaborate with the FDA to advance TSND-201 into phase 3 trials for PTSD treatment.

Solriamfetol Significantly Reduces ADHD Symptoms in Axsome’s Phase 3 Trial

Axsome Therapeutics’ phase 3 FOCUS trial found solriamfetol significantly reduced ADHD symptoms in adults, with a 45% mean reduction in AISRS scores and improvements seen as early as week 1. The trial met its primary and key secondary endpoints, demonstrating significant reductions in ADHD severity. Solriamfetol was well-tolerated, with a favorable safety profile.

While the 300 mg dose showed numerical improvements, statistical significance was not achieved. Axsome plans to initiate a pediatric trial for solriamfetol later this year.

Other Psychiatry Research

Meta-Analysis Confirms the Unlikelihood of GLP-1 RA Raising Suicidal Risk

A meta-analysis of 27 randomized clinical trials found no increased risk of suicide or self-harm with GLP-1 receptor agonists (GLP-1 RAs) for diabetes and obesity management. The study, involving > 59,000 participants, aligns with prior FDA evaluations and observational data, showing similar suicide-related event rates between GLP-1 RA and placebo groups. Investigators suggest these findings may ease safety concerns and support GLP-1 RAs as a potential alternative to bariatric surgery for patients at greater risk of suicidality.

Daily Discrimination’s Link to Depression, Anxiety Varies by Race

A study found that daily discrimination is linked to greater rates of depression and anxiety, with marginalized groups facing greater mental health risks. The research revealed that increased discrimination exposure significantly raised the odds of depression and anxiety, particularly among White, multiracial, and other racial groups. The link between discrimination and mental health was found to vary by race and ethnicity, suggesting that prolonged exposure to discrimination may lead some groups to internalize its effects or develop coping mechanisms.