CompletedPhase 2psilocybin
Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder
Sponsored by New York State Psychiatric Institute
NCT ID
NCT04656301
Target Enrollment
12 participants
Start Date
2021-02-26
Est. Completion
2022-11-02
About This Study
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.
Conditions Studied
Interventions
- •Psilocybin
Eligibility
Age:18 Years - 55 Years
Healthy Volunteers:No
View full 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
Study Locations (1)
New York State Psychiatric Institute, 1051 Riverside Drive
New York, New York, United States