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Volume 7
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Background:
Systematic Review

Efficacy of Psilocybin-Assisted Therapy in Major Depressive Disorder: A Systematic Review and Meta-Analysis

by
Angel Labra-Lorenzana
1,
Dania Nimbe Lima-Sánchez
2,*,
Christian Alejandro Delaflor-Wagner
3,
Diana Martínez-Hernández
4,
Christian Ramos-Jiménez
5 and
Christian Gabriel Toledo-Lozano
6,*
1
Psychiatric Hospital Fray Bernardino Álvarez, National Autonomous University of Mexico, Mexico City 14080, Mexico
2
Digital Health Department, Faculty of Medicine, National Autonomous University of Mexico, Mexico City 04510, Mexico
3
Department of Clinical Research, National Medical Center “20 de Noviembre”, Mexico City 03100, Mexico
4
Faculty of Medicine, Anahuac University of Oaxaca, Oaxaca 71248, Mexico
5
Integrated Program in Neuroscience, McGill University, Montreal, QC H3A 0G4, Canada
6
Research Coordination, National Medical Center “20 de Noviembre”, Mexico City 03100, Mexico
*
Authors to whom correspondence should be addressed.
Psychiatry Int. 2026, 7(3), 137; https://doi.org/10.3390/psychiatryint7030137
Submission received: 17 March 2026 / Revised: 7 June 2026 / Accepted: 8 June 2026 / Published: 15 June 2026
(This article belongs to the Section Addiction Psychiatry)
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Abstract

Background: This systematic review and meta-analysis evaluates the efficacy and safety of psilocybin-assisted psychotherapy (PAP) for adults with major depressive disorder (MDD). Methods: A PROSPERO-registered search (CRD42024561979) of CENTRAL, Scopus, PsycINFO, and MEDLINE (2010–2024) identified clinical trials assessing PAP. Risk of bias was assessed using RoB 2 for randomized controlled trials (RCTs), while non-randomized studies were appraised separately. Evidence certainty was evaluated using GRADE. Results: Ten trials were included; eight provided quantitative data. PAP was associated with large short-term reductions in depressive symptom severity. The overall pooled effect was large (d = 1.15, 95% CI 0.83–1.48), though within-subject designs yielded larger estimates (d = 1.63) than between-subject controlled comparisons (d = 0.96). Adverse events were transient and manageable, with no increased risk of serious adverse events on dosing days. Primary risk-of-bias concerns included functional unblinding. Conclusions: PAP may produce clinically meaningful, large short-term reductions in depressive symptoms. However, long-term efficacy remains understudied, and the overall certainty of evidence is low to moderate. Larger, rigorously blinded trials are required.
Keywords: psilocybin; major depressive disorder; review; treatment-resistant depression; meta-analysis psilocybin; major depressive disorder; review; treatment-resistant depression; meta-analysis

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MDPI and ACS Style

Labra-Lorenzana, A.; Lima-Sánchez, D.N.; Delaflor-Wagner, C.A.; Martínez-Hernández, D.; Ramos-Jiménez, C.; Toledo-Lozano, C.G. Efficacy of Psilocybin-Assisted Therapy in Major Depressive Disorder: A Systematic Review and Meta-Analysis. Psychiatry Int. 2026, 7, 137. https://doi.org/10.3390/psychiatryint7030137

AMA Style

Labra-Lorenzana A, Lima-Sánchez DN, Delaflor-Wagner CA, Martínez-Hernández D, Ramos-Jiménez C, Toledo-Lozano CG. Efficacy of Psilocybin-Assisted Therapy in Major Depressive Disorder: A Systematic Review and Meta-Analysis. Psychiatry International. 2026; 7(3):137. https://doi.org/10.3390/psychiatryint7030137

Chicago/Turabian Style

Labra-Lorenzana, Angel, Dania Nimbe Lima-Sánchez, Christian Alejandro Delaflor-Wagner, Diana Martínez-Hernández, Christian Ramos-Jiménez, and Christian Gabriel Toledo-Lozano. 2026. "Efficacy of Psilocybin-Assisted Therapy in Major Depressive Disorder: A Systematic Review and Meta-Analysis" Psychiatry International 7, no. 3: 137. https://doi.org/10.3390/psychiatryint7030137

APA Style

Labra-Lorenzana, A., Lima-Sánchez, D. N., Delaflor-Wagner, C. A., Martínez-Hernández, D., Ramos-Jiménez, C., & Toledo-Lozano, C. G. (2026). Efficacy of Psilocybin-Assisted Therapy in Major Depressive Disorder: A Systematic Review and Meta-Analysis. Psychiatry International, 7(3), 137. https://doi.org/10.3390/psychiatryint7030137

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