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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

No Placebo-Only Group

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 weeks3 visits

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

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

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Diarrhea

Influenza

Headache

Sinus headache

Depressed mood

Depression

Insomnia

Suicidal Ideation

Lower resp. tract congestion

Oropharyngeal pain

Alcohol withdrawal syndrome

Migraine

Thrombocytosis

Constipation

Vomiting

Oedema

Peripheral swelling

Pyrexia

Dermatitis contact

Bronchitis bacterial

Eye infection

Fungal infection

Traumatic lung injury

Hyponatremia

Arthralgia

Musculoskeletal pain

Pain in extremity

Malignant melanoma

Dizziness

Hypoesthesia

Sedation

Anger

Anxiety

Restlessness

Cough

Rhinorrhea

Sinus congestion

Sexual abuse

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

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

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

~530

0 / 7Eligibility criteria met