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Record W4417362478 · doi:10.1192/bjo.2025.10895

Psilocybin-assisted psychotherapy for treatment-resistant obsessive–compulsive disorder: protocol for an open-label pilot study

2025· article· en· W4417362478 on OpenAlexaff
Nicole Ledwos, Jenna Baer, Muhammad Ishrat Husain, Daniel M. Blumberger, Rachel Patterson, Elizabeth Hollingdrake, Ezmond S.L. Cheung, Colin Hawco, Christoph Zrenner, Brigitte Zrenner, Jamie D. Feusner, Susan L. Rossell, David Castle, Gwyneth Zai

Bibliographic record

VenueBJPsych Open · 2025
Typearticle
Languageen
FieldPsychology
TopicPsychedelics and Drug Studies
Canadian institutionsUniversity of TorontoCentre for Addiction and Mental Health
Fundersnot available
KeywordsProtocol (science)Pilot trialField (mathematics)Research designIntervention (counseling)

Abstract

fetched live from OpenAlex

BACKGROUND: Obsessive-compulsive disorder (OCD) is a debilitating mental disorder commonly treated with selective serotonin reuptake inhibitors, atypical antipsychotic augmentation and cognitive-behavioural therapy. However, up to 60% of people with OCD do not respond to these treatments. Therefore, a novel intervention, psilocybin-assisted psychotherapy (PAP), is an option of interest. Moreover, there is a need to better understand the mechanisms underpinning PAP's effect on OCD symptoms. AIMS: We aimed to (a) establish the feasibility, tolerability and safety of administering PAP to adults with treatment-resistant OCD; (b) provide preliminary data on the clinical effects of PAP for treatment-resistant OCD, to inform the design of larger clinical trials; and (c) compare neuroimaging and neurophysiological markers pre- and post-PAP in treatment-resistant OCD. METHOD: In this 12-week open-label trial, ten adults with treatment-resistant OCD will receive one 25 mg dose of psilocybin combined with psychological support. Feasibility, tolerability and safety will be assessed throughout. Clinical outcomes will be measured with the Yale-Brown Obsessive-Compulsive Scale. Exploratory measures will include brain imaging examining changes in dynamic connectivity from pre to post treatment, electroencephalogram to investigate changes in brain dynamics associated with psilocybin under acute conditions, and transcranial magnetic stimulation-electroencephalogram measures between baseline, provocation of OCD symptoms and up to 1-week post-dose. RESULTS: The study will provide important preliminary data on the feasibility and efficacy of PAP in adults with treatment-resistant OCD, as well as inform our understanding of neurobiological mechanisms. CONCLUSIONS: The findings of the study will inform the design of larger randomised controlled trials and advance the field of psychedelic-assisted therapies.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMeta-epidemiology (narrow)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: none
GenreCandidate signal: Protocol · Consensus signal: Protocol
Teacher disagreement score0.436
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.000
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.001
Science and technology studies0.0010.000
Scholarly communication0.0010.000
Open science0.0030.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.273
GPT teacher head0.537
Teacher spread0.264 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

Study designNot applicable
Domainnot available
GenreProtocol

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations2
Published2025
Admission routes1
Has abstractyes

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