A short-acting psychedelic intervention for major depressive disorder: a phase IIa randomized placebo-controlled trial

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Source: Nature Medicine

Original: https://www.nature.com/articles/s41591-025-04154-z...

Published: 2026-02-16

A phase IIa trial was randomized and placebo-controlled, testing the short-acting psychedelic dimethyltryptamine (DMT, SPL026) in combination with psychological support in 34 adult patients with moderate to severe major depressive disorder (MDD).[1] Patients discontinued antidepressants prior to the single intravenous dose.[1] After one week of treatment, DMT patients had an average of 10.8 points lower Montgomery-Åsberg Depression Rating Scale (MADRS) scores compared to placebo.[1] After two weeks, the score was another 7.4 points lower.[1] The results showed a statistically significant and clinically relevant reduction in depressive symptoms.[1] A single dose with supportive therapy had significant antidepressant effects lasting up to three months.[1] A second phase of the study was opened to compare the effect of one or two doses and to observe the durability of the effect.[1]