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Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

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ClinicalTrials.gov Identifier: NCT04656301
Recruitment Status : Recruiting
First Posted : December 7, 2020
Last Update Posted : March 16, 2021
Sponsor:
Collaborators:
COMPASS Pathways
University of California, Los Angeles
Information provided by (Responsible Party):
Franklin Schneier, New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE November 30, 2020
First Posted Date  ICMJE December 7, 2020
Last Update Posted Date March 16, 2021
Actual Study Start Date  ICMJE February 26, 2021
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2020)
Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder
Official Title  ICMJE Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Body Dysmorphic Disorders
Intervention  ICMJE Drug: Psilocybin
A single dose of psilocybin 25 mg will be administered orally in the Biological Studies Unit of New York State Psychiatric Institute
Study Arms  ICMJE Experimental: Psilocybin
A single dose of Psilocybin 25mg p.o.
Intervention: Drug: Psilocybin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 30, 2020)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gloria Gomez, BA 6467748113 gloria.gomez@nyspi.columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04656301
Other Study ID Numbers  ICMJE IRB#7950
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Franklin Schneier, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE
  • COMPASS Pathways
  • University of California, Los Angeles
Investigators  ICMJE
Principal Investigator: Franklin Schneier, MD Research Foundation for Mental Hygiene/NY State Psychiatric Institute
PRS Account New York State Psychiatric Institute
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP