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. Follow-up visits to monitor safety and clinical outcome will be conducted over a 3 month period.
Compound Psilocybin
Country United States of America
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Trial Details
Trial Number
Sponsors & Collaborators
New York State Psychiatric InstituteThe New York State Psychiatric Institute (NYSPI), established in 1895, was one of the first institutions in the United States to integrate teaching, research and therapeutic approaches to the care of patients with mental illnesses.
COMPASS Pathways
COMPASS Pathways is a publicly listed company (NASDAQ) that is developing psilocybin for treatment-resistant depression (TRD) for which it has completed a successful Phase IIb trial. COMPASS is one of the largest psychedelic companies and has received substantial investment from atai.
New York University
The Center for Psychedelic Medicine performs health-focused research across the translational spectrum, from basic science to large-scale clinical trials.
Papers
Pilot study of single-dose psilocybin for serotonin reuptake inhibitor-resistant body dysmorphic disorderThis open-label study (n=12) of patients suffering from Body dysmorphic disorder (BDD), an obsessive preoccupation with misperceptions of appearance, finds that psilocybin (25mg) plus psychological support (6 sessions) resulted in a response (>30% decrease in BDD-YBOCS) in 58% of participants. Secondary measures such as negative affect, disability, and conviction of belief also significantly decreased.
Measures Used
Yale-Brown Obsessive Compulsive ScaleThe Yale Brown Obsessive-Compulsive Scale (Y-BOSC) is considered the gold-standard to assess OCD severity. The scale consists of ten items and measures the severity and type of symptoms in people with OCD over the previous seven days. The scale is used at initial diagnosis as well as during follow up sessions after treatment. The scores range from 0 to 4, with higher scores indicating greater symptoms of OCD severity.