Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

Sponsor

New York State Psychiatric Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04656301

Collaborator

COMPASS Pathways (Industry), University of California, Los Angeles (Other)

Enrollment

Location

Arm

20.1

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Body Dysmorphic Disorders	Drug: Psilocybin	Phase 2

Detailed Description

In this pilot study, up to 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. Procedures will follow those previously established in depression studies of psilocybin. Patients will receive intensive preparation and support from two therapists, including 8-9 hours accompanying the patient on the day of medication administration in the Biological Studies Unit of New York State Psychiatric Institute. Followup visits to monitor safety and clinical outcome will be conducted at day 1, week1, and months 1,2, and 3 post-administration. Resting state function magnetic resonance imaging will be conducted prior to and one day after psilocybin administration to assess the effect of medication on brain circuits.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

Actual Study Start Date :

Feb 26, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Psilocybin A single dose of Psilocybin 25mg p.o.	Drug: Psilocybin A single dose of psilocybin 25 mg will be administered orally in the Biological Studies Unit of New York State Psychiatric Institute

Arm

Intervention/Treatment

Experimental: Psilocybin

A single dose of Psilocybin 25mg p.o.

Drug: Psilocybin

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

Outcome Measures

Primary Outcome Measures

Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale [From baseline (day -1) up to 3 months post-dose]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute, 1051 Riverside Drive	New York	New York	United States	10032

Sponsors and Collaborators

New York State Psychiatric Institute
COMPASS Pathways
University of California, Los Angeles

Investigators

Principal Investigator: Franklin Schneier, MD, Research Foundation for Mental Hygiene/NY State Psychiatric Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Franklin Schneier, Professor of Clinical Psychiatry, New York State Psychiatric Institute

ClinicalTrials.gov Identifier:

NCT04656301

Other Study ID Numbers:

IRB#7950

First Posted:

Dec 7, 2020

Last Update Posted:

Aug 2, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Body Dysmorphic Disorders

Psilocybin

Study Results

No Results Posted as of Aug 2, 2022