Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

NCT04656301 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB#7950
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Body Dysmorphic Disorders

Outcome Measures

Primary Outcomes (1)

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

  The Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) is a 12-item, semi-structured, rater-administered measure that assesses body dysmorphic disorder severity during the past week. Scores for each item range from 0 (no symptoms) to 4 (extreme symptoms); the total score ranges from 0 to 48, with higher scores reflecting more severe symptoms.

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

Study Arms (1)

Psilocybin

EXPERIMENTAL

A single dose of Psilocybin 25mg p.o.

Drug: Psilocybin

Interventions

Psilocybin DRUG

A single dose of psilocybin 25 mg will be administered orally in the Biological Studies Unit of New York State Psychiatric Institute

Psilocybin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• COMPASS Pathways: collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

New York State Psychiatric Institute, 1051 Riverside Drive

New York, New York, 10032, United States

Location

Related Publications (1)

• Zhu X, Zhang C, Hellerstein D, Feusner JD, Wheaton MG, Gomez GJ, Schneier F. Single-dose psilocybin alters resting state functional networks in patients with body dysmorphic disorder. Psychedelics (N Y). 2025;1(1):25-31. doi: 10.61373/pp024r.0028. Epub 2024 Sep 24.

  PMID: 40458078 DERIVED

MeSH Terms

Conditions

Body Dysmorphic Disorders

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Results Point of Contact

• Title: Dr. Franklin Schneier
• Organization: NY State Psychiatric Institute

franklin.schneier@nyspi.columbia.edu

6467748041

Study Officials

• Franklin Schneier, MD

  Research Foundation for Mental Hygiene/NY State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: February 26, 2021
• Primary Completion: November 2, 2022
• Study Completion: November 2, 2022
• Last Updated: March 13, 2023
• Results First Posted: March 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)