NCT04656301

Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Body Dysmorphic Disorders

Interventions

Type	Name	Description
DRUG	Psilocybin	A single dose of psilocybin 25 mg will be administered orally in the Biological Studies Unit of New York State Psychiatric Institute

Timeline

• Start date: 2021-02-26
• Primary completion: 2022-11-02
• Completion: 2022-11-02
• First posted: 2020-12-07
• Last updated: 2023-03-13
• Results posted: 2023-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study