Clinical TrialObsessive-Compulsive Disorder (OCD)PsilocybinCompleted

Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

Open-label pilot study (n=12) of a single oral 25 mg dose of psilocybin for adults with treatment-resistant body dysmorphic disorder with follow-up over 3 months.

Target Enrollment
12 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Open-label, single-group treatment study of up to 12 adult outpatients with body dysmorphic disorder receiving a single oral 25 mg dose of psilocybin with intensive therapeutic support.

Procedures follow prior psilocybin depression protocols: preparation and support from two therapists including 8–9 hours on dosing day, resting-state fMRI pre- and 1 day post-dose, and safety/clinical assessments at day 1, week 1, and months 1, 2, and 3.

Study Protocol

Preparation

sessions

Dosing

1 sessions
480 min each

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

Psilocybin

experimental

Single oral dose psilocybin 25 mg in a single-group open-label design.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Single oral dose of 25 mg psilocybin administered in the Biological Studies Unit.

Participants

Ages
18 – 55
Sexes
Male & Female

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 Details

Locations

New York State Psychiatric Institute, 1051 Riverside Drive — New York, New York, United States

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