4 Psychiatry Headlines You Missed in November 2025

November brought a mix of regulatory milestones, late-phase clinical insights, and evolving digital health trends across psychiatry. From the US Food & Drug Administration’s (FDA) first clearance of Deep Transcranial Magnetic Stimulation (Deep TMS) for adolescents with major depressive disorder (MDD) to a New Drug Application (NDA) filing that could introduce a novel ADHD mechanism of action, the month highlighted both therapeutic innovation and shifting treatment paradigms.

Clinicians also saw new phase 4 data on adjunctive perospirone for treatment-resistant depression and fresh evidence revealing the engagement challenges of mental health apps. Here are 4 psychiatry headlines you may have missed.

FDA Updates in Psychiatry

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

The FDA has cleared BrainsWay’s Deep TMS system for adolescents aged 15 - 21 years with major depressive disorder (MDD), expanding its previous approval for adults aged 22–86. This decision marks the first clearance of Deep TMS for a younger population that often has limited effective treatment options.

The expanded indication was supported by one of the largest real-world adolescent neuromodulation datasets submitted to the FDA, demonstrating substantial reductions in depressive and anxiety symptoms. In the supporting study, participants completed 36 sessions of either high-frequency Deep TMS or intermittent theta-burst stimulation, achieving a mean 12.1-point improvement on the PHQ-9 and a 66.1% response rate. Treatment consists of noninvasive magnetic stimulation delivered through a cushioned helmet in 20-minute daily sessions over 4–6 weeks. Adverse events were mild and consistent with adult data, most commonly headaches and localized discomfort.

Deep TMS is also FDA-cleared for OCD, anxious depression, and smoking cessation.

Otsuka Pharmaceuticals Submits NDA for Centanafadine to Treat ADHD in Children

Otsuka Pharmaceuticals has submitted an NDA to the FDA for centanafadine, a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) for treating ADHD in patients aged 4 – 55 years. The NDA is supported by 4 pivotal phase 3 trials evaluating once-daily, extended-release centanafadine across children, adolescents, and adults. In these studies, centanafadine produced statistically significant and clinically meaningful reductions in ADHD symptoms compared with placebo, measured by ADHD-RS-5 in younger patients and AISRS in adults.

High-dose treatment consistently showed the strongest effects, including significant improvements in children aged 4 - 12 years and adolescents aged 13 – 17 years, while both 200 mg and 400 mg doses were effective in adults. The medication was generally well tolerated; common adverse events included decreased appetite, nausea, rash, fatigue, and abdominal pain. The study observed somnolence in younger patients and decreased appetite and headache in adults.

Phase 4 MDD Results

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

Phase 4 trial results show perospirone is safe and well-tolerated as adjunctive therapy for MDD over 8 weeks, with potential, but inconclusive, efficacy benefits. The study enrolled 210 patients with inadequate response to SSRIs or SNRIs, randomized to perospirone or placebo added after 4 weeks of antidepressant treatment. While remission rates were greater with perospirone (55.2% vs 38.9%), response rates were similar between groups. Investigators noted a high placebo response, and expectancy effects may have reduced the observed drug-placebo difference. Overall, early adjunctive perospirone may offer benefit, but efficacy findings remain preliminary and require further study.

The High Uptake of Mental Health Apps

Mental Health Apps Gain High Uptake but Struggle With Adherence, Retention

A meta-analysis of 79 RCTs found that mental health apps achieve high uptake (92%) but only moderate adherence, with many users failing to complete follow-up assessments. Engagement improved with reminders and human support, while gamification did not boost retention. Across trials, 62% of users continued using apps, though real-world uptake is likely far lower.

Attrition rates ranged from 19% during treatment to 28% at follow-up, similar to dropout levels in psychotherapy and pharmacotherapy. Investigators noted that accountability features reduce attrition, and clinicians can use these insights to guide app recommendations and set realistic expectations for patients.