Efficacy and Safety of Psilocybin-Assisted Therapy for Depression: A Meta-Analysis of Randomised Controlled Trials

Psilocybin-assisted therapy shows promise for depression, though current evidence relies on Phase 2 trials with notable methodological limitations. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) evaluating psilocybin-assisted therapy for major or treatment-resistant depression up to February 2024. We evaluated depressive symptom severity using random-effects meta-analysis, moderator analyses, Cochrane Risk of Bias 2, and GRADE methodology. Nine RCTs (N=514) were included. Psilocybin therapy demonstrated a large pooled effect size for symptom reduction (SMD = 1.270, 95% CI: 0.865-1.676, p