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CompletedPhase 1

Efficacy of Psilocybin in OCD: a Double-Blind, Placebo-Controlled Study.

NCT03356483 · Yale University

Closed to entry
Status
Not accepting participants
Phase 1
Phase
31
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

This study aims to investigate the effects of oral psilocybin on OCD symptomatology and provide the first evidence of the neural mechanism that may mediate psilocybin's purported therapeutic effects on OCD.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Changes in severity of OCD symptoms, which will be measured by The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). The Primary Outcome Measure will be collected at baseline and 48 hours, assessing change from baseline at 48 hours.

    Measured over Baseline, 48 hours post-drug, weeks: 1, 2, 4, 12 post-drug

  • Changes in severity of OCD symptoms, measured by Acute Yale-Brown Obsessive-Compulsive Scale (A-YBOCS)

    Measured over Baseline, 24 hours post-drug, 48 hours post-drug

  • Changes in severity of OCD symptoms, measured by Visual Analog Scale (VAS) for OCD symptoms

    Measured over Baseline, 24 hours post-drug, 48 hours post-drug

  • Changes in suicidality, measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit version

    Measured over Up to 12 weeks post-drug

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Primary DSM-5 diagnosis of OCD 2. Y-BOCS score of 19 or greater 3. Failure of at least one trial of standard care treatment (medication and/or psychotherapy \[CBT/ERP\]) for OCD 4. English proficiency and fluency, and ability to understand the consent process and provide written informed consent 5. Willingness to sign a medical release for direct communication between research staff and external provider(s) about the participant's treatment and medical histories 6. Non-consumption of SSRIs for at least 8 weeks at the time of randomization 7. Willingness to refrain from psychiatric medications (e.g., antidepressants, first- and second-generation antipsychotics, mood stabilizers) during the study period, as well as certain other medications (e.g., anti-seizure medications, cardiovascular medications, and aldomet specifically) during the day of dosing 8. Willingness to abstain from THC-containing products for study duration. A negative urinary drug screen is also required at baseline and the day of dosing. 9. A negative urinary pregnancy screen at study entry and day of dosing if of childbearing potential, and willingness to use adequate birth control for study duration 10. Having a contact person who is willing and able to be reached by the study team in the event of an emergency/crisis, and who is able to transport the participant home at the end of the inpatient stay/dosing week 11. Willingness to commit to all study procedures and visits, including inpatient stay, assessments and self-reports, neuroimaging, and being medically cleared to be discharged and transported home at the end of the dosing week Exclusion Criteria: 1. Personal or immediate family history of schizophrenia spectrum and other psychotic disorders, bipolar I or II disorder, or major depressive disorder with psychotic features 2. Active suicidal intent 3. Unremitted Tourette syndrome 4. Autism spectrum disorder 5. OCPD or BPD 6. Current substance use disorder (except mild alcohol use disorder) 7. Unstable neurological or medical condition(s) that may render study procedures unsafe, including poorly managed diabetes, hypertension, or cardiovascular conditions, or history of seizure(s) or chronic/severe headaches 8. Any history of head injury with loss of consciousness for more than 30 minutes 9. Any contraindications to undergoing an MRI scan, including having metal implants or metal fragments in the body 10. Any use of psychedelic substances within the prior 12 months

Where

1 study site

FacilityCityRegionCountry
Connecticut Mental Health CenterNew HavenConnecticutUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03356483 on ClinicalTrials.gov →

Last updated in the registry 2024-11-20. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits