Clinical trial NCT04656301: Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder
Official title: Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Body Dysmorphic Disorders
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: COMPASS Pathways
name: University of California, Los Angeles
First posted: 2020-12-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale
timeFrame: From baseline (day -1) up to 3 months post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute, 1051 Riverside Drive
state: New York
Study officials:
affiliation: Research Foundation for Mental Hygiene/NY State Psychiatric Institute
name: Franklin Schneier, MD
role: PRINCIPAL_INVESTIGATOR
References: