Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder
Completed · Phase 2
Conditions studied: Body Dysmorphic Disorders
In brief
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.
Key facts
- Study ID
- NCT04656301
- Run by
- New York State Psychiatric Institute
- People needed
- 12
- Starts
- 2021-02-26
- Expected to finish
- 2022-11-02
- Last updated by the study team
- 2023-03-13
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- New York State Psychiatric Institute, 1051 Riverside Drive — New York, New York, United States
Full record on ClinicalTrials.gov
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