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| Name | Class |
|---|---|
| COMPASS Pathways | INDUSTRY |
| University of California, Los Angeles | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psilocybin | Experimental | A single dose of Psilocybin 25mg p.o. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin | Drug | A single dose of psilocybin 25 mg will be administered orally in the Biological Studies Unit of New York State Psychiatric Institute |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline (day -1) up to 3 months post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franklin Schneier, MD | Research Foundation for Mental Hygiene/NY State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute, 1051 Riverside Drive | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40458078 | Derived | Zhu X, Zhang C, Hellerstein D, Feusner JD, Wheaton MG, Gomez GJ, Schneier F. Single-dose psilocybin alters resting state functional networks in patients with body dysmorphic disorder. Psychedelics (N Y). 2025;1(1):25-31. doi: 10.61373/pp024r.0028. Epub 2024 Sep 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | From baseline (day -1) up to 3 months post-dose |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fatigue | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Franklin Schneier | NY State Psychiatric Institute | 6467748041 | franklin.schneier@nyspi.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2023 | Feb 14, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D057215 | Body Dysmorphic Disorders |
| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011562 | Psilocybin |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale | Mean | Standard Deviation | scale score |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 11 |
| 12 |
| headache | Nervous system disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| somnolence | Nervous system disorders | Non-systematic Assessment |
|
| Lightheadedness | Nervous system disorders | Non-systematic Assessment |
|
| spaciness | Nervous system disorders | Non-systematic Assessment |
|
| insomnia | General disorders | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | Non-systematic Assessment |
|
| pneumonia | Infections and infestations | Non-systematic Assessment |
|
| low libido | Reproductive system and breast disorders | Non-systematic Assessment |
|
| emotional lability | Psychiatric disorders | Non-systematic Assessment |
|
| visual hallucination | Psychiatric disorders | Non-systematic Assessment |
|
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |