6 Psychiatry Headlines You Missed in January 2026

January 2026 delivered a wave of consequential developments across psychiatry, spanning regulatory milestones, predictive treatment insights, and emerging biological and therapeutic frameworks for depression and ADHD. From the US Food & Drug Administration (FDA) approval of the first at-home neuromodulation device for treatment-resistant major depressive disorder (MDD) to a priority review for a potential first-in-class ADHD therapy, the month underscored continued momentum toward more personalized, accessible psychiatric care.

Investigators also sharpened the clinical lens on treatment response, with new analyses identifying early predictors of sustained benefit with adjunctive cariprazine and broad symptom improvements with lumateperone following its recent FDA approval. Complementing these advances, expert interviews explored the biological links between asthma and depression, the mechanistic role of BDNF, and the growing evidence that preparation psychotherapy may be a key driver of response in psychedelic-assisted treatment.

This roundup highlights the psychiatry headlines you may have missed in January 2026, offering clinicians a concise overview of the data, decisions, and discussions shaping current practice.

Regulatory Updates in Psychiatry

FDA Approves ProlivRx, First At-Home Neuromodulation Device for MDD

The FDA has approved ProlivRx, the first at-home, physician-directed neuromodulation therapy for adults with MDD unresponsive to antidepressants. Developed by Neurolief, ProlivRx delivers external Combined Occipital and Trigeminal Afferent Stimulation (eCOT-AS). In the MOOD trial, led by Linda Carpenter, MD (Brown University, Butler Hospital) and Mark S. George, MD (Medical University of South Carolina), ProlivRx significantly improved remission rates with a favorable safety profile.

FDA Accepts NDA for Priority Review of Centanafadine to Treat Adult, Pediatric ADHD

The FDA has accepted the NDA for priority review of centanafadine, a once-daily extended-release norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) for ADHD in children, adolescents, and adults. Developed by Otsuka Pharmaceutical Development & Commercialization, centanafadine has a PDUFA target date of July 24, 2026. Across 4 phase 3 trials, centanafadine significantly improved ADHD symptoms versus placebo and was generally well tolerated, supporting its potential as a first-in-class ADHD therapy.

Predicting the Benefit of Adjunct Cariprazine for MDD

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

Early symptom improvement by week 2 predicts sustained antidepressant benefit with adjunctive cariprazine (VRAYLAR) in MDD, according to a meta-analysis by Jeffrey R. Strawn, MD, and colleagues at Cincinnati Children’s Hospital Medical Center. Across 2 phase 3 trials, cariprazine 1.5 mg and 3 mg significantly improved MADRS scores versus placebo. Greater baseline depression severity, female sex, and SSRI use predicted stronger responses, while comorbid anxiety was linked to smaller symptom reductions.

Expert Insight into Depression with Asthma, Preparation Before Psychedelics, Lumateperone for MDD

Elevated BDNF Linked to Depressive Symptoms in Patients with Asthma, With Hiroshi Iwamoto, MD, PhD

Elevated serum brain-derived neurotrophic factor (BDNF) is associated with greater depressive symptoms in adults with asthma, suggesting asthma-related depression may differ biologically from major depressive disorder. In the PACTAS study of 140 patients, greater BDNF levels correlated with worse mood, greater asthma severity, poorer control, and lower physical activity. According to investigator Hiroshi Iwamoto, MD, PhD, of Hiroshima University, in a Q&A, findings point to inflammatory or stress-related mechanisms, highlighting the need for integrated management of asthma control and mental health.

Preparation Before Psychedelics Tied to Better MDD, With Gianluca Florineth, MSc

Greater exposure to preparation psychotherapy before psychedelic dosing is associated with larger reductions in depressive symptoms, according to a meta-analysis led by Gianluca Florineth, MSc, of the University of Bern. Pooling 12 trials of psilocybin- or LSD-assisted therapy in depression, each additional hour of preparation predicted greater symptom improvement. Integration therapy and total psychotherapy duration were not linked to short-term outcomes, suggesting preparation sessions—by enhancing safety, expectations, and therapeutic alliance—may be a key driver of antidepressant response.

Lumateperone Shows Broad Symptom Benefit for MDD, With Michael E. Thase, MD

Related: Phase 3 Data Bolster FDA Approval of Lumateperone as Adjunctive MDD Therapy, With Suresh Durgam, MD

Adjunctive lumateperone 42 mg (CAPLYTA) provides broad symptom benefits in treatment-resistant MDD, according to analyses reviewed by Michael E. Thase, MD, of the University of Pennsylvania. Following FDA approval in November 2025, pooled trials showed greater MADRS remission and complete remission rates versus placebo, with improvements across mood, anxiety, sleep, and life satisfaction. Long-term data demonstrated sustained efficacy, minimal weight gain, low neurologic adverse effects, and a favorable safety profile.