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CompletedPhase 2Results posted

Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

NCT04656301 · New York State Psychiatric Institute

Closed to entry
Status
Not accepting participants
Phase 2
Phase
12
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

In this pilot study 12 adult outpatients with body dysmorphic disorder that has not responded to at least one adequate trial of a serotonin reuptake inhibitor will be treated openly with a single oral dose of psilocybin. Followup visits to monitor safety and clinical outcome will be conducted over a 3 month period.

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

  • Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale

    Measured over From baseline (day -1) up to 3 months post-dose

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

18 Years to 55 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Body dysmorphic disorder of at least moderate severity, non-delusional subtype, for \>6 months * History of intolerance of, or nonresponse to, a prior adequate trial of a serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) * Currently in psychotherapy (other than cognitive behavioral therapy (CBT) for body dysmorphic disorder Exclusion Criteria: * Current major depressive disorder of greater than moderate severity * Other significant psychiatric or medical comorbidity or conditions that could interfere with safety of participation or interpretation of outcomes * Use of: investigational medication within 3 months of baseline; depot antipsychotic within 6 months of baseline; serotonergic medication within 2 weeks of baseline (6 weeks for fluoxetine). * Females who are pregnant, breastfeeding, or sexually active and not willing to use adequate contraception * Enrollment in any investigational drug or device study in past 30 days * Prior adverse effects from psilocybin

Where

1 study site

FacilityCityRegionCountry
New York State Psychiatric Institute, 1051 Riverside DriveNew YorkNew YorkUnited 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.

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NCT04656301 on ClinicalTrials.gov →

Last updated in the registry 2023-03-13. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits