Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

Study Overview
=================
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.

Official Title
-----------------
Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

Conditions
-----------------
Body Dysmorphic Disorders

Intervention / Treatment
-----------------
* Drug: Psilocybin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |