Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

Phase 2

Completed

• Conditions: Body Dysmorphic Disorders
• Interventions: Drug: Psilocybin

• Registration Number: NCT04656301
• Lead Sponsor: New York State Psychiatric Institute

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.

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 Timeline

• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-11-30
• Study First Posted: 2020-12-07
• Study Start: 2021-02-26
• Primary Completion: 2022-11-02
• Study Completion: 2022-11-02
• Status Verified: 2023-02
• Results First Submitted: 2023-02-14
• Results First Submitted QC: 2023-02-14
• Last Update Submitted: 2023-02-14
• Results First Posted: 2023-03-13
• Last Update Posted: 2023-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Psilocybin	Psilocybin	A single dose of Psilocybin 25mg p.o.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

New York State Psychiatric Institute, 1051 Riverside Drive; 🇺🇸 New York, New York, United States