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Psychedelic

Psilocybin for Endothelial Dysfunction

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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (day -1) up to 3 months post-dose
Awards & highlights
No Placebo-Only Group

Summary

This trial will test psilocybin, a substance from certain mushrooms, on adults with body dysmorphic disorder who haven't improved with typical antidepressants. Psilocybin may help by changing how serotonin works in the brain, potentially resetting mood and perception circuits. Psilocybin has shown promise as a treatment for depression and was designated as a breakthrough therapy by the FDA in 2019.

Eligible Conditions
  • Endothelial Dysfunction
  • Body Dysmorphic Disorder

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

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

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~530

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
478 Previous Clinical Trials
153,961 Total Patients Enrolled
COMPASS PathwaysIndustry Sponsor
14 Previous Clinical Trials
1,546 Total Patients Enrolled
University of California, Los AngelesOTHER
1,566 Previous Clinical Trials
10,263,442 Total Patients Enrolled
6 Trials studying Endothelial Dysfunction
379 Patients Enrolled for Endothelial Dysfunction
~3 spots leftby Dec 2025
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