Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

New York State Psychiatric Institute

Status and phase: Completed; Phase 2

Conditions: Body Dysmorphic Disorders

Treatments: Drug: Psilocybin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04656301

IRB#7950

Details and patient eligibility

About

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.

Full description

In this pilot study, up to 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. Procedures will follow those previously established in depression studies of psilocybin. Patients will receive intensive preparation and support from two therapists, including 8-9 hours accompanying the patient on the day of medication administration in the Biological Studies Unit of New York State Psychiatric Institute. Followup visits to monitor safety and clinical outcome will be conducted at day 1, week1, and months 1,2, and 3 post-administration. Resting state function magnetic resonance imaging will be conducted prior to and one day after psilocybin administration to assess the effect of medication on brain circuits.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Psilocybin

Experimental group

Description:

A single dose of Psilocybin 25mg p.o.

Treatment:

Drug: Psilocybin