Reporting of side-effects in clinical trials of psilocybin-assisted psychotherapy for psychiatric conditions: systematic review.

ABSTRACT:

Background

Psilocybin-assisted psychotherapy (PAP) has gained attention as a promising intervention for conditions including depression, anxiety and post-traumatic stress disorder, but understanding of its side-effects is limited. This review evaluates the quality of side-effects reporting in PAP trials, to guide treatment, policy and research.

Aims

To assess side-effects reporting quality in PAP trials for psychiatric conditions, comparing published articles and ClinicalTrials.gov records.

Method

A PROSPERO-registered review (no. CRD42023458960) included English-language PAP trials (2005-2024) identified via Embase, CENTRAL, PubMed and reference searches. Reporting quality was assessed using the CONSORT Harms extension, categorised as either high (17-21), moderate (1

SUBMITTER: Marinis J 

PROVIDER: S-EPMC12641409 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature