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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 belowSelect...
The person has a body dysmorphic disorder that is at least moderate in severity and is the non-delusional subtype
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline (day -1) up to 3 months post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (day -1) up to 3 months post-dose
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 • NCT0206129344%
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
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