Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborators: COMPASS Pathways; University of California, Los Angeles
• Treatments: Psilocybin

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