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Clinical trial

Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

ID
Name
IRB#7950
Description
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.
Trial arms
Trial start
2021-02-26
Estimated PCD
2022-11-02
Trial end
2022-11-02
Status
Completed
Phase
Early phase I
Treatment
Psilocybin
A single dose of psilocybin 25 mg will be administered orally in the Biological Studies Unit of New York State Psychiatric Institute
Arms:
Psilocybin
Size
12
Primary endpoint
Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale
From baseline (day -1) up to 3 months post-dose
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}
Updated at
2023-03-13

1 organization

1 product

1 indication

Organization
New York State Psychiatric Institute
Product
Psilocybin
Indication
Body Dysmorphic Disorder