5 Psychiatry Headlines You Missed in September 2026

September brought regulatory and research momentum for psychedelic therapies in psychiatry. The US Food & Drug Administration (FDA) granted DT120 (lysergide) orally disintegrating tablet (ODT) a second Breakthrough Therapy designation, this time in major depressive disorder (MDD), and held a public hearing on how psychedelic care would be delivered if approved. Meanwhile, a proposed fix for blinding failures in psychedelic trials addressed questions about how these agents are being studied.

Outside of psychedelics, new secondary analysis data showed accelerated Deep Transcranial Magnetic Stimulation (Deep TMS) eased suicidal ideation faster than standard daily dosing. Here are 5 psychiatry headlines you may have missed.

DT120 ODT Receives Second FDA Breakthrough Therapy Designation in MDD

On September 8, the FDA granted Breakthrough Therapy designation to DT120 (lysergide) ODT for MDD, following an earlier designation for generalized anxiety disorder (GAD) in August.¹ The designation was supported by the phase 3 Emerge trial, in which a single 100 µg dose produced an 8.1-point placebo-adjusted improvement in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at week 6 (P < .0001), with efficacy maintained through week 12.² Definium Therapeutics is also developing DT120 ODT for PTSD, and the announcement did not include new MDD-specific safety data.¹

What the FDA Psychedelic Hearing Means for Psychiatrists

The FDA held a 4-hour public hearing on September 14 on provider training, patient safety, access, and data standards for psychedelic therapies, with SAMHSA, NIDA, and the Veterans Health Administration on the listening panel.³ Sarah Norman, MPP, executive director of BrainFutures, said speakers consistently called for competency-based training that builds on existing licensed professionals rather than a new provider type. She noted DEA rescheduling may take approximately 90 days after an FDA approval, and that written comments remain open on regulations.gov until October 5.³

Phase 3 PARADIGM: HLP003 (Psilocibin-d10) for Adjunctive MDD Use

Trial design data presented at Psych Congress 2026 outlined Helus Pharma's phase 3 PARADIGM program for HLP003 (formerly CYB003), a deuterated psilocin analog with Breakthrough Therapy designation for adjunctive use in MDD.⁴ APPROACH randomized 223 participants to 16 mg HLP003 or placebo, and EMBRACE is randomizing approximately 330 participants to 16 mg, 8 mg, or placebo, with doses on days 1 and 22 and a primary endpoint of MADRS change at day 42. APPROACH topline data are expected in the fourth quarter of 2026, with a potential New Drug Application (NDA) targeted for 2028.⁴

UMBRAA Framework Aims to Fix Blinding Failures in Psychedelic Trials

A Viewpoint published September 16 in JAMA Psychiatry proposed UMBRAA, a strategy combining a stimulant, sedative, anticholinergic, and cannabinoid as an active placebo, paired with incomplete disclosure of trial arm composition.⁵ Participants correctly guess their assignment > 90% of the time in high-dose psychedelic trials, compared with approximately 60% in antidepressant trials. Author Josh D. Woolley, MD, PhD, of the University of California, San Francisco, said the authors would manage multidrug risks by repurposing FDA-approved agents under monitoring standards already used in psychedelic trials.⁵

Deep TMS Reduces Suicidal Ideation by 70% in MDD, With Owen Muir, MD

A secondary analysis of a multisite randomized trial (n = 89) found the proportion of patients with any suicidal ideation fell from 22.5% at baseline to 6.7% after 6 weeks, a 70% relative reduction across both dosing arms.⁶ Patients on the SWIFT accelerated protocol reached a median ≥ 1-point Scale for Suicide Ideation improvement in 10 days, compared with 13 days for standard once-daily dosing. Owen Muir, MD, of Radial, noted the trial excluded the most severely suicidal patients and that Deep TMS is not FDA-cleared for suicidal ideation but said, "if you're looking at time to remission of suicidality, accelerated TMS is the clear choice."⁶

Read more: Q&A: Accelerated TMS Speeds Suicidal Ideation Relief, With Owen Muir, MD