Body Dysmorphic DisordersPhase 2NCT04656301
Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder
A Phase 2 study testing Psilocybin in people with Body Dysmorphic Disorders, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Body Dysmorphic Disorders
- What is being tested?
- Psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2021to 2 Nov 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute, 1051 Riverside Drive
New York, New York, 10032
About this study
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.
Read the 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.
- Conditions
- Body Dysmorphic Disorders
- Being tested
- Psilocybin
- Medical subject headings
- Body Dysmorphic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
A single dose of psilocybin 25 mg will be administered orally in the Biological Studies Unit of New York State Psychiatric Institute
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin | Experimental | A single dose of Psilocybin 25mg p.o. Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (day -1) up to 3 months post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start26 Feb 2021
- Primary completion2 Nov 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body Dysmorphic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- COMPASS Pathways, University of California, Los Angeles
- Responsible party
- Principal investigator, Franklin Schneier, New York State Psychiatric Institute
- Investigators
- Franklin Schneier, MD, Principal investigator, Research Foundation for Mental Hygiene/NY State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656301
- Sponsor's protocol ID
- IRB#7950
- Status last verified
- Feb 2023
- First submitted
- 30 Nov 2020
- Last updated
- 13 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40458078
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder
- ClinicalTrials.gov ID
- NCT04656301
- Acronym / sponsor ID
- IRB#7950
- Conditions
- Body Dysmorphic Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- COMPASS Pathways, University of California, Los Angeles
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Posted 13 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psilocybin | Experimental | Drug: PsilocybinA single dose of Psilocybin 25mg p.o. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinA single dose of psilocybin 25 mg will be administered orally in the Biological Studies Unit of New York State Psychiatric Institute | Drug | Psilocybin |
Primary outcome
Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40458078Zhu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franklin Schneier, MD principal investigator
Research Foundation for Mental Hygiene/NY State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin in people with Body Dysmorphic Disorders, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale (time frame: From baseline (day -1) up to 3 months post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04656301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.