A short-acting psychedelic intervention for major depressive disorder: a phase IIa randomized placebo-controlled trial - PubMed
5 days ago
- #depression
- #psychedelic
- #clinical trial
- A phase IIa randomized placebo-controlled trial evaluated the efficacy and safety of intravenous DMT (SPL026) for major depressive disorder (MDD).
- Participants received a single 21.5-mg dose of DMT or placebo, with supportive psychotherapy, followed by a 2-week assessment.
- The DMT group showed a significantly greater reduction in MADRS scores compared to placebo at 2 weeks (mean difference = -7.35; P = 0.023).
- Antidepressant effects persisted up to 3 months in the open-label phase, with no significant difference between one or two doses.
- Adverse events were mostly mild to moderate, including infusion site pain, nausea, and transient anxiety, with no serious adverse events reported.
- The study suggests that a single dose of DMT with psychotherapy can produce rapid and sustained reduction in depressive symptoms, with good tolerability and safety.