Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. (February 2022)

• Record Type: Journal Article
• Authors: Gukasyan, Natalie; Davis, Alan K; Barrett, Frederick S; Cosimano, Mary P; Sepeda, Nathan D; Johnson, Matthew W; Griffiths, Roland R
• Is Part Of: Journal of psychopharmacology. Volume 36:Number 2(2022)
• Page Start: 151
• Page End: 158
• Publication Date: 2022-02
• Subjects: Insight -- long-term effects -- major depressive disorder -- mystical experience -- psilocybin; Psychopharmacology -- Periodicals; 615.78
• DOI: 10.1177/02698811211073759
• Languages: English
• ISSNs: 0269-8811

Abstract

Background: Preliminary data suggest that psilocybin-assisted treatment produces substantial and rapid antidepressant effects in patients with major depressive disorder (MDD), but little is known about long-term outcomes. Aims: This study sought to examine the efficacy and safety of psilocybin through 12 months in participants with moderate to severe MDD who received psilocybin. Methods: This randomized, waiting-list controlled study enrolled 27 patients aged 21–75 with moderate to severe unipolar depression (GRID-Hamilton Depression Rating Scale (GRID-HAMD) ⩾ 17). Participants were randomized to an immediate or delayed (8 weeks) treatment condition in which they received two doses of psilocybin with supportive psychotherapy. Twenty-four participants completed both psilocybin sessions and were followed through 12 months following their second dose. Results: All 24 participants attended all follow-up visits through the 12-month timepoint. Large decreases from baseline in GRID-HAMD scores were observed at 1-, 3-, 6-, and 12-month follow-up (Cohen d = 2.3, 2.0, 2.6, and 2.4, respectively). Treatment response (⩾50% reduction in GRID-HAMD score from baseline) and remission were 75% and 58%, respectively, at 12 months. There were no serious adverse events judged to be related to psilocybin in the long-term follow-up period, and no participants reported psilocybin use outside of the context of the study. Participant ratings of personal meaning, spiritual experience, and mystical experience after sessions predicted increased well-being at 12 months, but did not predict improvement in depression. Conclusions: These findings demonstrate that the substantial antidepressant effects of psilocybin-assisted therapy may be durable at least through 12 months following acute intervention in some patients.