4 Psychiatry Headlines You Missed in December 2025

As 2025 closed, psychiatry continued to advance with notable US Food & Drug Administration (FDA) submissions, late-stage clinical trial results, and emerging insights linking mental health to broader medical conditions. December highlighted progress in schizophrenia treatment, with Teva’s TEV- ‘749 entering the regulatory pipeline, and in major depressive disorder (MDD), as adjunctive lumateperone demonstrated rapid symptom improvement.

This month’s review captures these developments alongside a retrospective look at the year, offering clinicians a concise summary of the therapies, trials, and innovations shaping psychiatric practice.

Teva Seeks FDA Approval for Novel Schizophrenia Therapy

Teva Pharmaceuticals Submits NDA on TEV-‘749 for Schizophrenia to the FDA

Teva Pharmaceuticals submitted a New Drug Application (NDA) to the FDA for TEV-‘749, a once-monthly olanzapine extended-release injectable for adults with schizophrenia. TEV-‘749 utilizes Medincell’s SteadyTeq™ technology, a proprietary copolymer system that provides controlled, sustained release of olanzapine.

The phase 3 SOLARIS trial, a 56-week, multinational, multicenter, randomized, double-blind study, evaluated efficacy, safety, and tolerability in patients aged 18 to 64 years. Results showed TEV-‘749 had a consistent efficacy and safety profile compared with oral olanzapine, with high satisfaction reported by patients, nurses, and physicians.

Unlike other long-acting injectables such as risperidone and aripiprazole, TEV- ‘749 introduces a new molecule option. Experts at SUNY Upstate Medical University noted its potential to improve adherence, reduce relapses, and address treatment gaps for the 3.5 million Americans living with schizophrenia, supporting long-term stability.

Adjunctive Lumateperone Shows Strong Phase 3 Results in MDD

Adjunctive Lumateperone Significantly Improves MDD Symptoms by Day 43

A phase 3, randomized, double-blind trial demonstrated that lumateperone 42 mg, when added to antidepressant therapy, significantly improves depressive symptoms in adults with MDD by day 43. Conducted by Intra-Cellular Therapies following FDA approval in 2025, the study assessed 480 adults with inadequate response to 1 or 2 antidepressants. Lumateperone targets serotonin, dopamine, and glutamate neurotransmission, acting as a 5-HT2A antagonist while modulating D2, D1, AMPA, and NMDA activity.

Primary endpoints—changes in MADRS and CGI-S scores—were met, with notable patient-reported improvements. The drug was generally well tolerated, with common adverse events including dizziness, somnolence, and nausea.

Intersecting Care: Dermatologic Conditions and Psychiatric Outcomes

Psychological Distress Greater in Patients With Androgenetic Alopecia

A systematic review of 13 studies involving 2737 patients with androgenetic alopecia (AGA) and 17,382 controls found that individuals with AGA experience significantly greater levels of generalized anxiety, social anxiety, depression, and perceived stress. The condition also negatively impacts self-esteem, body image, life satisfaction, and social functioning. Despite some conflicting findings on depression, the review highlights the substantial psychosocial burden of AGA.

Investigators from Beijing Changping Hospital recommend routine psychological assessment in clinical practice and integrated care with dermatologists and psychologists, including cognitive-behavioral therapy or pharmacotherapy when needed, to support emotional well-being and improve quality of life for patients living with AGA.

2025 Year in Review: Key Approvals, Trials

Psychiatry in 2025: Year in Review

In 2025, psychiatry advanced on multiple fronts, with new FDA approvals, clinical innovations, and emerging therapies enhancing care across depression, ADHD, schizophrenia, and anxiety. Esketamine (SPRAVATO®) became the first monotherapy for treatment-resistant depression, while lumateperone (CAPLYTA) and BrainsWay’s Deep TMS offered novel adjunctive and noninvasive options for adolescents with MDD.

Long-acting injectables such as TEV-‘749 for schizophrenia and expanded-use risperidone and buprenorphine formulations improved adherence and maintenance strategies. ADHD management progressed with centanafadine and solriamfetol, showing rapid, sustained symptom improvement, and phase 2b trials of MM120 (LSD) demonstrated durable reductions in generalized anxiety. Combined with expert guidance on dermatologic comorbidities, relapse prevention, and safe psychedelic use, these developments in 2025 broadened the tools available to clinicians and reinforced more individualized, patient-centered approaches in psychiatric care.