Evidence map›Paper›PMID 41178084›Full record

ReviewBJPsych open2025

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

Jonathon Marinis, Sarah T Clarke, Alexandre A Guerin, Adam J Guastella, Gillinder Bedi

Abstract readReview
In one paragraph

Review in BJPsych open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Classifying Psychedelic-Related Complications.Current topics in behavioral neurosciences · 2026
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Jonathon MarinisCentre for Youth Mental Health, https://ror.org/01ej9dk98University of Melbourne and Orygen, Australia.ORCID https://orcid.org/0009-0006-8487-4152
Sarah T ClarkeCentre for Youth Mental Health, https://ror.org/01ej9dk98University of Melbourne and Orygen, Australia.
Alexandre A GuerinCentre for Youth Mental Health, https://ror.org/01ej9dk98University of Melbourne and Orygen, Australia.
Adam J GuastellaClinic for Autism and Neurodevelopmental Research, Brain and Mind Centre, Children's Hospital Westmead Clinical School, Faculty of Medicine and Health, University of Sydney, Australia.ORCID https://orcid.org/0000-0001-8178-4625
Gillinder BediCentre for Youth Mental Health, https://ror.org/01ej9dk98University of Melbourne and Orygen, Australia.ORCID https://orcid.org/0000-0002-6718-0099

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPsilocybin-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.

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

methodA 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 (12-16), low (7-11) or very low (0-6). Randomised controlled trials underwent risk of bias analysis, and descriptive statistics compared side-effects across sources.

resultsTwenty-four trials were included. Reporting quality was high in six studies, moderate in four, low in nine and very low in five. All randomised controlled trials (

conclusionsSide-effects reporting in PAP trials is inconsistent but is improving over time. Existing evidence has a high risk of bias. Future trials should align with best-practice guidelines for side-effects reporting. Discussions with patients should prioritise findings from high-quality studies and emphasise the current uncertainty regarding PAP side-effects.

Indexed as

adverse eventshealth policyPsilocybin-assisted psychotherapyquality of reportingside-effects

Identifiers

PMID41178084
PMCPMC12641409

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.