Overview
- A Nature Medicine phase IIa two-stage randomized trial tested a 21.5 mg intravenous DMT dose with structured psychotherapy in 34 adults with major depressive disorder.
- DMT recipients had significantly larger MADRS score reductions than placebo at one and two weeks, with group-level improvements maintained up to three months and some reports extending to six months.
- At one week, response and remission were 44% each with DMT versus 6% and 13% with placebo; at two weeks, response was 35% versus 12% and remission 29% versus 12%.
- Exploratory analyses in the open-label second stage showed no clear added benefit from a second dose compared with one.
- No serious adverse events were reported; transient heart rate and blood pressure spikes and mild-to-moderate symptoms were common, while small sample size, demographic homogeneity, and potential unblinding limit generalizability, and greater benefit tracked with more intense psychedelic experiences.