Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

Body Dysmorphic Disorders Clinical Trial

Official title:

Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04656301
• Other study ID #: IRB#7950
• Status: Completed
• Phase: Phase 2
• Start date: February 26, 2021
• Est. completion date: November 2, 2022

Study information

• Verified date: February 2023
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2, 2022
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Dysmorphic Disorders

Intervention

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

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute, 1051 Riverside Drive	New York	New York

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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