Body Dysmorphic Disorders
Conditions
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.
Interventions
DRUGPsilocybin
A single dose of psilocybin 25 mg will be administered orally in the Biological Studies Unit of New York State Psychiatric Institute
Sponsors
COMPASS Pathways
University of California, Los Angeles
New York State Psychiatric Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale | From baseline (day -1) up to 3 months post-dose | The Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) is a 12-item, semi-structured, rater-administered measure that assesses body dysmorphic disorder severity during the past week. Scores for each item range from 0 (no symptoms) to 4 (extreme symptoms); the total score ranges from 0 to 48, with higher scores reflecting more severe symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Psilocybin A single dose of Psilocybin 25mg p.o.
Psilocybin: A single dose of psilocybin 25 mg will be administered orally in the Biological Studies Unit of New York State Psychiatric Institute | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Psilocybin |
|---|---|
| Age, Continuous | 34.31 years STANDARD_DEVIATION 8.86 |
| Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale | 29.17 scale score STANDARD_DEVIATION 4.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 11 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale
The Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) is a 12-item, semi-structured, rater-administered measure that assesses body dysmorphic disorder severity during the past week. Scores for each item range from 0 (no symptoms) to 4 (extreme symptoms); the total score ranges from 0 to 48, with higher scores reflecting more severe symptoms.
Time frame: From baseline (day -1) up to 3 months post-dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psilocybin | Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale | 18.42 score on a scale | Standard Deviation 9.8 |
p-value: <0.001t-test, 2 sided