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SYSTEMATIC REVIEW article

Front. Psychiatry
Sec. Mood Disorders
Volume 15 - 2024 | doi: 10.3389/fpsyt.2024.1416420
This article is part of the Research Topic Rising Stars in Psychiatry: 2024 View all 4 articles

Psilocybin for major depressive disorder: A systematic review of randomized controlled studies

Provisionally accepted
Li-Juan Li Li-Juan Li 1Yu Mo Yu Mo 2Zhan-Ming Shi Zhan-Ming Shi 3Xing-Bing Huang Xing-Bing Huang 4Yu-Ping Ning Yu-Ping Ning 4Hua-Wang Wu Hua-Wang Wu 4Xin-Hu Yang Xin-Hu Yang 4Wei Zheng Wei Zheng 4*
  • 1 First Affiliated Hospital of Hainan Medical University, Haikou, Hainan Province, China
  • 2 The Brain Hospital of Guangxi Zhuang Autonomous Region, Liuzhou, Guangxi Zhuang Region, China
  • 3 Chongqing Jiangbei Mental Health Center, Chongqing, China
  • 4 The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou, China

The final, formatted version of the article will be published soon.

    The purpose of this systematic review of randomized controlled trials (RCTs) was to evaluate the effectiveness, safety, and tolerability of psilocybin in adult patients with major depressive disorder (MDD). Methods: A systematic search (up to September 14, 2023) was conducted for RCTs that examined the efficacy, safety, and tolerability of psilocybin in physically healthy adult patients with MDD. Three independent researchers extracted data from publications where the primary outcome was a change in depressive symptoms, and key secondary outcomes were changes in anxiety symptoms and suicidal ideation, discontinuation rates for any reason, and adverse drug reactions (ADRs). Results: Five RCTs with 472 adult patients with MDD on psilocybin (n = 274) and controls (n = 198) were included. Two of the five RCTs (40%) reported mixed results, while the other three (60%) found that psilocybin had a beneficial effect on MDD treatment. Four RCTs (80%) assessing the anxiolytic effects of psilocybin for treating MDD found that psilocybin was significantly more effective than the control group in improving anxiety symptoms. Psilocybin was more effective than the control group in improving suicidal ideation in one out of five RCTs. Discontinuation rates were similar for any reason between the psilocybin group (2-13%) and the control group (4-21%) (P>0.05). Four RCTs (80%) reported ADRs in detail. The most common ADR in both groups was headache. Conclusion: Psilocybin was effective in improving depressive symptoms in over half of the included studies and reduced anxiety symptoms in patients with MDD. The long-term efficacy and safety of psilocybin for MDD treatment needs to be further investigated in large RCTs.

    Keywords: psilocybin, Major Depressive Disorder, Systematic review, efficacy, RCT - randomized controlled trial

    Received: 12 Apr 2024; Accepted: 16 Aug 2024.

    Copyright: © 2024 Li, Mo, Shi, Huang, Ning, Wu, Yang and Zheng. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Wei Zheng, The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.