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Psychedelic

Psilocybin for Obsessive-Compulsive Disorder

Phase 1
Recruiting
Led By Benjamin Kelmendi, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not be on psychotropic medications for OCD or comorbid psychiatric conditions for at least 8 weeks at the time of randomization, and agree to refrain from taking or starting any psychiatric medications until after 4 weeks post-second dose
Failed at least one medication and/or therapy trial of standard care treatment for OCD
Must not have
Any neurological condition, including history of seizure(s) or chronic/severe headaches
Personal or immediate (first-degree relative) family history of formally diagnosed schizophrenia or other psychotic disorders, or bipolar I/II disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every study visit through study completion, an average of 12 months and 3 weeks for immediate treatment condition, and an average of 12 months and 10 weeks for waitlist condition
Awards & highlights

Summary

This trial tests if taking psilocybin pills can help people with OCD by changing how their brain processes thoughts and emotions. The study compares different amounts of psilocybin to see if it reduces OCD symptoms more effectively. Psilocybin is a naturally occurring substance that has shown promise in treating mood and substance use disorders.

Who is the study for?
This trial is for adults with a primary diagnosis of OCD, who have tried at least one standard treatment without success. Participants must be fluent in English, able to take oral pills, not on psychotropic medications or psychotherapy for 8 weeks prior to the study and agree not to start any during the study. They should provide an emergency contact and commit to all procedures including lifestyle changes.
What is being tested?
The trial tests how repeated doses of psilocybin affect OCD symptoms compared to a waitlist group. It's randomized and includes blinded ratings. The goal is also to understand psychological processes that might explain psilocybin's potential benefits in treating OCD.
What are the potential side effects?
While specific side effects are not listed here, psilocybin can potentially cause changes in perception, mood swings, dizziness, nausea, confusion or disorientation during the time it affects the brain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't taken any psychiatric drugs for OCD or other mental health issues for 8 weeks.
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I have tried at least one standard OCD treatment without success.
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My OCD is severe, with a high Y-BOCS-II score.
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I can swallow pills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a neurological condition or a history of seizures or severe headaches.
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I or my close family member have been diagnosed with schizophrenia, bipolar disorder, or another psychotic disorder.
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My Tourette syndrome has not improved.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every study visit through study completion, an average of 12 months and 3 weeks for immediate treatment condition, and an average of 12 months and 10 weeks for waitlist condition
This trial's timeline: 3 weeks for screening, Varies for treatment, and every study visit through study completion, an average of 12 months and 3 weeks for immediate treatment condition, and an average of 12 months and 10 weeks for waitlist condition for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Yale-Brown Obsessive-Compulsive Scale-Second Edition (Y-BOCS-II) Severity Scale total score from baseline at 4 days post-second dose
Secondary study objectives
Challenging Experience Questionnaire (CEQ)
Change in Acceptance and Action Questionnaire for Obsessions and Compulsions (AAQ-OC) total score from baseline at 4 days post-second dose
Change in Alcohol Use Disorders Identification Test (AUDIT) total score from baseline at 4 weeks post-second dose
+26 more

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate TreatmentExperimental Treatment1 Intervention
Participants randomized to this condition will receive treatment immediately, facilitated by two study staff members, and which consists of two preparatory sessions, followed by the first dosing session and two integration sessions, then the second dosing session and two integration sessions. This is followed by follow-up and long-term follow-up visits up to 12 months post-second dose.
Group II: Waitlist Control/Delayed TreatmentActive Control1 Intervention
Participants randomized to this condition will first enter a waitlist phase that lasts for 7 weeks, after which rater unblinding will occur, and participants will be rescreened. If participants remain eligible at this time, they will begin their treatment phase. During their treatment phase, participants in this condition will receive the same treatment as described for participants in the immediate treatment group. This is followed by follow-up and long-term follow-up visits up to 12 months post-second dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~750

Find a Location

Who is running the clinical trial?

Steven & Alexandra Cohen FoundationOTHER
7 Previous Clinical Trials
228 Total Patients Enrolled
Yale UniversityLead Sponsor
1,907 Previous Clinical Trials
3,019,019 Total Patients Enrolled
11 Trials studying Obsessive-Compulsive Disorder
567 Patients Enrolled for Obsessive-Compulsive Disorder
Benjamin Kelmendi, MDPrincipal InvestigatorYale University
3 Previous Clinical Trials
81 Total Patients Enrolled
1 Trials studying Obsessive-Compulsive Disorder
31 Patients Enrolled for Obsessive-Compulsive Disorder

Media Library

Psilocybin (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT05370911 — Phase 1
Obsessive-Compulsive Disorder Research Study Groups: Immediate Treatment, Waitlist Control/Delayed Treatment
Obsessive-Compulsive Disorder Clinical Trial 2023: Psilocybin Highlights & Side Effects. Trial Name: NCT05370911 — Phase 1
Psilocybin (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05370911 — Phase 1
Obsessive-Compulsive Disorder Patient Testimony for trial: Trial Name: NCT05370911 — Phase 1
~18 spots leftby Jul 2026
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