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Psychedelic

Psilocybin for Body Dysmorphic Disorder

Phase 2
Waitlist Available
Led By Franklin Schneier, MD
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body dysmorphic disorder of at least moderate severity, non-delusional subtype, for >6 months
Currently in psychotherapy (other than cognitive behavioral therapy (CBT) for body dysmorphic disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (day -1) up to 3 months post-dose
Awards & highlights

Study Summary

This trial will study the effects of psilocybin on body dysmorphic disorder in 12 patients who have not responded to other treatment. Follow-up visits will be conducted over 3 months to monitor safety and clinical outcome.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
The person has a body dysmorphic disorder that is at least moderate in severity and is the non-delusional subtype

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (day -1) up to 3 months post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day -1) up to 3 months post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
44%
Headache
21%
Nausea
15%
Anxiety
8%
Suicidal Ideation
6%
Insomnia
6%
Depressed mood
4%
Abdominal pain upper
4%
Vomiting
4%
Corona virus infection
4%
Upper respiratory tract infection
4%
Viral upper resp. tract infection
4%
Alcohol poisoning
4%
Depression
4%
Pneumonia
2%
Urinary incontinence
2%
Illusion
2%
Biopsy cervix
2%
Palpitations
2%
Cataract
2%
Abdominal pain
2%
Toothache
2%
Pain
2%
Limb injury
2%
Muscle strain
2%
Blood pressure diastolic increased
2%
Blood pressure increased
2%
Back pain
2%
Musculoskeletal pain
2%
Myalgia
2%
Dizziness
2%
Psychomotor hyperactivity
2%
Alcohol withdrawal syndrome
2%
Dysphoria
2%
Testicular pain
2%
Hyperventilation
2%
Food poisoning
2%
Food allergy
2%
Dyspepsia
2%
Influenza
2%
Nasal congestion
2%
Skin cosmetic procedure
2%
Photopsia
2%
Diverticulitis
2%
Asthenia
2%
Fatigue
2%
Gingivitis
2%
Dyspnea
2%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Psilocybin
Diphenhydramine

Trial Design

1Treatment groups
Experimental Treatment
Group I: PsilocybinExperimental Treatment1 Intervention
A single dose of Psilocybin 25mg p.o.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~770

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
474 Previous Clinical Trials
153,245 Total Patients Enrolled
COMPASS PathwaysIndustry Sponsor
14 Previous Clinical Trials
1,546 Total Patients Enrolled
University of California, Los AngelesOTHER
1,518 Previous Clinical Trials
10,278,748 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Louisiana
California
Other
New York
How old are they?
< 18
18 - 65
What site did they apply to?
New York State Psychiatric Institute, 1051 Riverside Drive
New York State Psychiatric Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’ve tried about six medications that haven’t worked and I’ve been in therapy.
PatientReceived 1 prior treatment
~3 spots leftby Mar 2025