Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

New York State Psychiatric Institute12 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Body Dysmorphic Disorders

Interventions

PsilocybinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

New York State Psychiatric Institute, 1051 Riverside Drive

New York, New York, United States

Outcomes

Primary Outcomes

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.

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.