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Psilocybin-assisted therapy for major depressive disorder: Perspective from meta-analysis
Taro Kishi1, Kenji Sakuma1, Masakazu Hatano2
1Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan.
Journal of Affective Disorders
|March 24, 2026
Summary
Standard-dose psilocybin shows significant efficacy in reducing major depressive disorder (MDD) symptoms, improving response and remission rates. While associated with temporary side effects like headache and nausea, it offers a promising therapeutic avenue for MDD.
Area of Science:
- Psychiatry and Mental Health
- Pharmacology
- Clinical Trials
Background:
- Major Depressive Disorder (MDD) is a leading cause of disability worldwide.
- Current treatments for MDD have limitations in efficacy and tolerability.
- Psilocybin, a psychedelic compound, is being investigated for its therapeutic potential in mental health conditions.
Purpose of the Study:
- To systematically review and meta-analyze randomized controlled trials on psilocybin for MDD.
- To investigate the temporal changes in efficacy and safety of standard- and low-dose psilocybin.
- To assess the impact of psilocybin on depressive symptoms, response, remission, and discontinuation rates.
Main Methods:
- Systematic review and meta-analysis of six randomized controlled trials.
- Separate analyses for standard-dose (25 mg) and low-dose (10 mg) psilocybin.
- Comparison against various control conditions including placebo, waiting-list, niacin, and low-dose psilocybin.
Main Results:
- Standard-dose psilocybin significantly reduced depressive symptoms compared to controls (SMD: -1.05).
- Higher response (RR: 2.34) and remission rates (RR: 3.38) were observed with standard-dose psilocybin.
- Standard-dose psilocybin was associated with temporary headache and nausea but lower all-cause discontinuation.
- Low-dose psilocybin did not show superior efficacy compared to controls.
Conclusions:
- Standard-dose psilocybin demonstrates potential as a therapeutic option for MDD.
- Further research is needed to address methodological heterogeneity in existing trials.
- Psilocybin-assisted psychotherapy shows promise for treating major depressive disorder.
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