Back to resultsSafety and Efficacy of Psilocybin for Body Dysmorphic Disorder
Primary Purpose
Body Dysmorphic Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Psilocybin
Sponsored by
About this trial
This is an interventional treatment trial for Body Dysmorphic Disorders
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
Sites / Locations
- New York State Psychiatric Institute, 1051 Riverside Drive
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Psilocybin
Arm Description
A single dose of Psilocybin 25mg p.o.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04656301
First Posted
November 30, 2020
Last Updated
February 14, 2023
Sponsor
New York State Psychiatric Institute
Collaborators
COMPASS Pathways, University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT04656301
Brief Title
Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder
Official Title
Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 26, 2021 (Actual)
Primary Completion Date
November 2, 2022 (Actual)
Study Completion Date
November 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
COMPASS Pathways, University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Dysmorphic Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psilocybin
Arm Type
Experimental
Arm Description
A single dose of Psilocybin 25mg p.o.
Intervention Type
Drug
Intervention Name(s)
Psilocybin
Intervention Description
A single dose of psilocybin 25 mg will be administered orally in the Biological Studies Unit of New York State Psychiatric Institute
Primary Outcome Measure Information:
Title
Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franklin Schneier, MD
Organizational Affiliation
Research Foundation for Mental Hygiene/NY State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute, 1051 Riverside Drive
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder
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