Morning Rounds: News from April 27-May 1

Full of US Food and Drug Administration (FDA) action and policy discussion, see the highlights in psychiatry from the last week.

Pharmaceutical Updates

FDA Approves Auvelity for Treatment of Agitation in Dementia

The FDA has approved Auvelity (dextromethorphan-bupropion) for agitation associated with dementia, addressing a major unmet clinical need.¹ Agitation in dementia is often managed with off-label antipsychotics despite safety concerns, including increased mortality risk. Auvelity’s mechanism combines NMDA receptor antagonism with norepinephrine-dopamine reuptake inhibition, targeting glutamatergic and monoaminergic pathways. Clinical trials demonstrated significant reductions in agitation with relatively rapid onset compared with placebo. Common adverse effects included dizziness, somnolence, and gastrointestinal symptoms, with a potentially more favorable safety profile than antipsychotics. Auvelity is now the second approved medication for agitation in dementia, joining Rexulti (brexpiprazole).

FDA Expands Caplyta Label to Include Schizophrenia Relapse Prevention

The FDA has expanded the indication for Caplyta (lumateperone) to include maintenance treatment and relapse prevention in schizophrenia.² Lumateperone’s multimodal mechanism includes serotonin 5-HT2A antagonism, dopamine modulation, and glutamatergic effects. Clinical studies show prolonged time to relapse among stabilized patients compared with placebo. The drug maintains a favorable tolerability profile, with low rates of extrapyramidal symptoms and minimal metabolic effects. This expanded indication supports its use across both acute and maintenance phases, particularly in patients with cardiometabolic risk.

Policy & Legislation

Bipartisan "Ensuring Excellence in Mental Health Act" Introduced Could Permanently Authorize CCBHCs Under Medicare and Medicaid

The “Ensuring Excellence in Mental Health Act” is a bipartisan bill introduced proposing permanent authorization of Certified Community Behavioral Health Clinics (CCBHCs) under Medicare and Medicaid.³ CCBHCs deliver integrated services, including crisis care, outpatient treatment, and care coordination with standardized reimbursement models. Evidence from demonstration programs suggests improved access to care and reduced hospitalization rates. Permanent authorization could stabilize funding and expand nationwide adoption of integrated behavioral health care. Potential challenges include workforce shortages and variability in state implementation.

AFSP and JED Organizations Plan to Merge, Creating Largest Suicide Prevention Nonprofit

The American Foundation for Suicide Prevention (AFSP) and The JED Foundation plan to merge, forming the largest US suicide prevention nonprofit.⁴ The merger combines AFSP’s research and advocacy efforts with JED’s focus on youth and campus mental health. The unified organization aims to scale evidence-based prevention strategies and expand national reach. Priorities include early identification, stigma reduction, and improved access to mental health resources. Integration challenges remain but reflect a broader trend toward coordinated prevention efforts.

Clinical Research

Study Finds Semaglutide Improved Motivation in Patients With Major Depressive Disorder

Recent research suggests semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, may improve motivational deficits in major depressive disorder.⁵ Motivational impairment remains a core and often treatment-resistant domain of depression. This secondary analysis of a double-blind, randomized clinical trial show improved measures of motivation in patients receiving semaglutide compared with placebo. Semaglutide reduced patients’ perceived cost of effort of tasks, with a significant pattern of increased willingness to exert physical effort for higher expected rewards (P = 0.02). Although preliminary, these results highlight the potential role of metabolic agents like GLP-1s in treating neuropsychiatric disorders involving reward dysfunction.

References

1. Kuntz L. FDA approves Auvelity for treatment of agitation in Alzheimer disease. Psychiatric Times. April 30, 2026. https://www.psychiatrictimes.com/view/fda-approves-auvelity-for-treatment-of-agitation-in-alzheimer-disease

2. Kuntz L. FDA approves sNDA of Caplyta for the prevention of relapse in schizophrenia. Psychiatric Times. April 27, 2026. https://www.psychiatrictimes.com/view/fda-approves-snda-of-caplyta-for-the-prevention-of-relapse-in-schizophrenia

3. Pfluger, colleagues introduce legislation to strengthen mental health resources. Press release. April 28, 2026. Accessed May 1, 2026. https://pfluger.house.gov/news/documentsingle.aspx?DocumentID=2953

4. Kuntz L. AFSP and JED announces intent to merge and become the largest suicide prevention nonprofit. Psychiatric Times. April 22, 2026. https://www.psychiatrictimes.com/view/afsp-and-jed-announce-intent-to-merge-and-become-the-largest-suicide-prevention-nonprofit

5. Gill H, Badulescu S, Shah H, et al. Semaglutide and effort-based decision-making in major depressive disorder: a randomized clinical trial. JAMA Psychiatry. 2026:e260594.