Q4 2025 Recap: Psychiatry News and Updates

The final quarter of 2025 brought several US Food & Drug Administration (FDA) approvals, clearances, and submissions in psychiatry, along with new clinical data shaping treatment approaches. Highlights include extended-release options for bipolar disorder and schizophrenia, expanded Deep Transcranial Magnetic Stimulation system use for adolescents with major depressive disorder (MDD), and phase 3 and 4 results for adjunctive therapies. Studies also explored predictors of treatment response, effects of neuromodulation and vagus nerve stimulation, and the influence of diet and cardiometabolic side effects, offering insights for personalized psychiatry care.

Here, we captured 12 psychiatry news from the past quarter.

FDA News in Psychiatry You Missed in Q4

FDA Approves Risperidone Extended-Release Injectable for Bipolar I Disorder

FDA approved Teva Pharmaceuticals’ UZEDY, a once-monthly extended-release risperidone injection, for adult bipolar I disorder maintenance therapy. As the first subcutaneous long-acting risperidone using SteadyTeq technology, UZEDY expands beyond schizophrenia, offering monotherapy or adjunctive treatment with lithium or valproate.

FDA Clears BrainsWay’s TMS Device for Adolescents with MDD Aged 15 to 21 Years

The FDA cleared BrainsWay’s TMS as adjunctive therapy for adolescents aged 15 to 21 with MDD. The expanded label, supported by real-world data, showed significant reductions in depressive and anxiety symptoms with a favorable safety profile, extending prior adult-only approval.

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 subcutaneous olanzapine extended-release injectable for adult schizophrenia. Supported by phase 3 SOLARIS trial data, TEV-‘749 uses SteadyTeq technology and demonstrated efficacy and safety comparable to oral olanzapine, with high patient and clinician satisfaction.

Otsuka Pharmaceuticals Submits NDA for Centanafadine to Treat ADHD in Children

Otsuka Pharmaceuticals submitted an NDA to the FDA for centanafadine, a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor, to treat ADHD in patients aged 4 to 55 years. The application is supported by 4 phase 3 trials demonstrating significant, clinically meaningful symptom improvements and a favorable tolerability profile.

Phase 3 & 4 Data

Adjunctive Lumateperone Significantly Improves MDD Symptoms by Day 43

A phase 3 trial found adjunctive lumateperone 42 mg significantly improved depressive symptoms and disease severity by day 43 in adults with MDD. Following FDA approval in 2025, lumateperone met primary and secondary endpoints on MADRS and CGI-S, showing meaningful efficacy with a generally favorable safety profile.

Digital Therapeutic Reduces Negative Symptoms of Schizophrenia in Phase 3 Trial

A phase 3 trial showed CT-155, an investigational prescription digital therapeutic from Boehringer Ingelheim and Click Therapeutics, significantly reduced negative symptoms of schizophrenia when used adjunctively with antipsychotics. CT-155 achieved greater CAINS-MAP improvements than a digital control, with high engagement and favorable tolerability.

Adjunctive Perospirone Safe, Well-Tolerated for MDD in Phase 4 Trial

A phase 4 randomized trial found adjunctive perospirone was safe and well-tolerated in adults with MDD and inadequate SSRI/SNRI response. Although remission rates were higher with perospirone than placebo at 8 weeks, response rates were similar, and efficacy findings were considered hypothesis-generating due to a high placebo effect.

Other Psychiatry News from Last Quarter

Early Week 2 Response Predicts Sustained Benefit with Adjunct Cariprazine in MDD

Early response to adjunctive cariprazine (VRAYLAR) by week 2 predicts sustained antidepressant benefits in adults with MDD. Greater baseline depression, female sex, and concomitant SSRI use were linked to stronger responses, highlighting predictors for optimizing individualized adjunctive treatment strategies.

Early Heart Rate Slowing Predicts Magnetic Brain Stimulation Response in MDD

Heart rate slowing within 45 seconds of Intermittent theta burst stimulation (iTBS) predicts greater 6-week improvement in depressive symptoms in MDD. Personalized stimulation sites did not enhance efficacy, highlighting early cardiac changes as a potential biomarker for treatment response.

Non-Invasive Vagus Nerve Stimulation Boosts Food Liking in Depression

Right transcutaneous auricular vagus nerve stimulation (taVNS) acutely increased food liking in MDD patients, particularly those with high anhedonia, without affecting motivation. This shows the potential of taVNS as a personalized adjunct therapy for reward deficits in depression.

Soft Drinks Linked to Depression Through Gut Microbiota Alterations

Soft drink consumption is linked to increased depression risk and symptom severity, especially in women, potentially mediated by gut microbiota changes involving Eggerthella. This research highlights diet as a modifiable factor in MDD prevention.

Antidepressants Differ Significantly in Cardiometabolic Side Effects

A large analysis of 30 antidepressants in 58,534 patients found significant differences in cardiometabolic side effects, including weight, heart rate, and blood pressure, informing safer, personalized antidepressant selection.