Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

We are currently enrolling individuals with significant and distressing body image concerns (e.g., concerns about skin, hair, nose) to participate in a research study that will assess whether a single dose of psilocybin may be a safe and effective treatment to improve appearance -related worries. For eligible participants, the research study will involve 1 visit that is around 8 hours during which they will receive psilocybin with the support of a therapist. Participants will then return for follow-up visits over the course of 12 weeks. The study will also assess the effect of the treatment on brain activity using a scan called magnetic resonance imaging (MRI).

Participants will receive compensation for completing the study.

IRB Approval # 7950

Organization
New York State Psychiatric Institute/Research Foundation for Mental Hygiene
Principal Investigator
Franklin Schneier, MD
Eligibility Criteria
  • Males and females between the ages of 18-55
  • Current primary diagnosis of body dysmorphic disorder (BDD)
  • History of intolerance or non-response to a prior adequate trial of an SSRI, SNRI, or clomipramine
     
Exclusion Criteria
  • Current and severe major depressive disorder
  • Current or past bipolar disorder, psychotic disorder, or borderline personality disorder
  • Alcohol or drug use disorder in the past 3 months
  • Current significant suicidality or a suicide attempt within the past year
  • Body image concerns accounted for primarily by an eating disorder , or that are only weight-related
  • Current cognitive-behavioral therapy specific for BDD
  • Enrollment in any investigational drug or device study in the past 30 days
  • Past negative effects from psilocybin
     
Location
New York State Psychiatric Institute
State
NY
Study End Date

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