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This trial evaluated the feasibility and short-term efficacy of a single 25-mg dose of psilocybin, administered with psychological support, in 60 adults with treatment-resistant major depressive disorder at an NHS site in England. Participants were randomized to psilocybin or placebo, with 6 weeks of follow-up. At week 3, the adjusted between-group difference in Montgomery–Åsberg Depression Rating Scale (MADRS) scores was −10.41 points (95% CI, −14.86 to −5.95; Cohen’s d = −1.70), favouring psilocybin, and the improvement was sustained at week 6. Almost all participants (59/60) completed all MADRS assessments. Although more non-serious adverse events occurred in the psilocybin group (164 vs 123), the study demonstrated feasibility and a promising short-term antidepressant signal, supporting the need for a larger confirmatory trial
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This trial evaluated the feasibility and short-term efficacy of a single 25-mg dose of psilocybin, administered with psychological support, in 60 adults with treatment-resistant major depressive disorder at an NHS site in England. Participants were randomized to psilocybin or placebo, with 6 weeks of follow-up. At week 3, the adjusted between-group difference in Montgomery–Åsberg Depression Rating Scale (MADRS) scores was −10.41 points (95% CI, −14.86 to −5.95; Cohen’s d = −1.70), favouring psilocybin, and the improvement was sustained at week 6. Almost all participants (59/60) completed all MADRS assessments. Although more non-serious adverse events occurred in the psilocybin group (164 vs 123), the study demonstrated feasibility and a promising short-term antidepressant signal, supporting the need for a larger confirmatory trial
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