Phase 2
N=12
Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder
Body Dysmorphic Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04656301 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale — 18.42 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Psilocybin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale |
18.42 | <0.001 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT04656301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.