Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up

Feb 15, 2022Journal of psychopharmacology (Oxford, England)

Effectiveness and safety of psilocybin treatment for major depression over 12 months

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Abstract

Seventy-five percent of participants experienced a treatment response after 12 months following psilocybin-assisted therapy.

Large decreases in depression scores were observed at 1, 3, 6, and 12 months post-treatment.
The average effect size of the treatment measured by Cohen's d was substantial, ranging from 2.0 to 2.6 across follow-up periods.
Fifty-eight percent of participants achieved remission of major depressive disorder symptoms after 12 months.
No serious adverse events related to psilocybin were reported during the long-term follow-up.
Personal and spiritual experiences reported by participants predicted increased well-being, but not depression improvement.

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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 = 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. d

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.

Key numbers

75%

Treatment Response Rate

Percentage of participants showing ≥50% reduction in GRID-HAMD scores at 12 months.

58%

Remission Rate

Percentage of participants with GRID-HAMD score ≤7 at 12 months.

15.1

Mean GRID-HAMD Score Decrease

Mean reduction in GRID-HAMD scores from 22.8 at baseline to 7.7 at 12 months.

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Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up

Abstract

Key numbers

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