A Phase 2 interventional study of Psilocybin in Body Dysmorphic Disorders, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-03-13.
Sponsored by New York State Psychiatric Institute · Phase 2, Interventional, and Treatment
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.
56 studies on the registry are indexed under Body Dysmorphic Disorders; 11 are open to participants now.
This study's enrollment of 12 is below the median of 52 across 44 interventional studies indexed under Body Dysmorphic Disorders.
Browse Body Dysmorphic Disorders studies →New York State Psychiatric Institute is the lead sponsor of 435 studies on the registry; 27 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 45 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single dose of Psilocybin 25mg p.o.
Drug: Psilocybin
A single dose of psilocybin 25 mg will be administered orally in the Biological Studies Unit of New York State Psychiatric Institute
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
| Milestone | Psilocybin |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
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.
| score on a scale | Psilocybin |
|---|---|
| Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale | 18.42 ± 9.80 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Psilocybin | 0/12 (0%) | 0/12 (0%) | 11/12 (91.7%) |
| Event | Psilocybin |
|---|---|
| fatigueGeneral disorders | 5/12 |
| headacheNervous system disorders | 3/12 |
| nauseaGastrointestinal disorders | 2/12 |
| somnolenceNervous system disorders | 1/12 |
| LightheadednessNervous system disorders | 1/12 |
| spacinessNervous system disorders | 1/12 |
| insomniaGeneral disorders | 1/12 |
| COVID-19Infections and infestations | 1/12 |
| pneumoniaInfections and infestations | 1/12 |
| low libidoReproductive system and breast disorders | 1/12 |
| Age, Continuous(years) | Psilocybin |
|---|---|
| Mean | 34.31 ± 8.86 |
| Sex: Female, Male(Participants) | Psilocybin |
|---|---|
| Female | 8 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Psilocybin |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 12 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Psilocybin |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Psilocybin |
|---|---|
| United States | 12 |
| Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale(scale score) | Psilocybin |
|---|---|
| Mean | 29.17 ± 4.60 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Psilocybin
New York State Psychiatric Institute →