Phase 2b Trial Evaluating Inhaled N,N-Dimethyltryptamine DMT for Moderate to Severe Major Depressive Disorder Treatment

What this Trial Is About

Researchers are evaluating inhaled N,N-dimethyltryptamine DMT as a potential treatment for adults with Major Depressive Disorder MDD, focusing on whether it can quickly reduce depressive symptoms and suicide risk. This Phase 2b, randomized, double-blind, active-controlled clinical trial compares a high-dose DMT regimen with a low-dose active comparator. MDD is a disabling condition with limited effective treatments, and this study aims to assess the safety and rapid antidepressant effects of inhaled DMT. Participants are randomly assigned to receive either a high-dose inhaled DMT 15 mg followed by 60 mg one hour later or a low-dose inhaled DMT 1 mg followed by 4 mg one hour later. Those who do not achieve remission by Day 7 receive an open-label high-dose DMT session around Day 14. The study includes up to 140 participants and follows them for up to 12 months to evaluate durability of response, safety, functioning, and quality of life. During the trial, participants undergo assessments of depression severity using the Montgomery-sberg Depression Rating Scale MADRS and other measures at multiple time points including baseline, post-dosing, and follow-ups up to one year. Safety is monitored through adverse event reporting and vital signs. Researchers also assess suicidality, psychological functioning, quality of life, and biological markers. This comprehensive evaluation helps determine the potential of inhaled DMT in treating moderate to severe MDD over time.

Inhaled DMT for Major Depressive Disorder