Immediate Psilocybin for Obsessive-Compulsive Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Obsessive-Compulsive DisorderPsilocybin - Drug
Eligibility
21 - 70
All Sexes
What conditions do you have?
Select

Study Summary

This study will test the feasibility, safety, and evidence for efficacy of psilocybin administration in participants with obsessive compulsive disorder (OCD). This will serve as a preliminary proof of concept study for future larger studies aimed to investigate the utility, cognitive mechanisms, and neural correlates of this intervention.

Eligible Conditions
  • Obsessive-Compulsive Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: 1 month post session 2

Month 1
Mental Depression
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Anxiety
Week 1
Change in The Yale Brown Obsessive Compulsive Scale (Y-BOCS) score

Trial Safety

Safety Progress

1 of 3

Side Effects for

Psilocybin
44%Headache
21%Nausea
15%Anxiety
8%Suicidal Ideation
6%Depressed mood
6%Insomnia
4%Vomiting
4%Corona virus infection
4%Alcohol poisoning
4%Viral upper resp. tract infection
4%Pneumonia
4%Depression
4%Upper respiratory tract infection
4%Abdominal pain upper
2%Testicular pain
2%Limb injury
2%Biopsy cervix
2%Dysphoria
2%Oropharyngeal pain
2%Dyspepsia
2%Food allergy
2%Alcohol withdrawal syndrome
2%Pain
2%Influenza
2%Muscle strain
2%Musculoskeletal pain
2%Dizziness
2%Illusion
2%Nasal congestion
2%Skin cosmetic procedure
2%Psychomotor hyperactivity
2%Blood pressure diastolic increased
2%Fatigue
2%Urinary incontinence
2%Asthenia
2%Palpitations
2%Abdominal pain
2%Food poisoning
2%Photopsia
2%Cataract
2%Toothache
2%Back pain
2%Blood pressure increased
2%Myalgia
2%Gingivitis
2%Diverticulitis
2%Hyperventilation
2%Dyspnea
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT02061293) in the Psilocybin ARM group. Side effects include: Headache with 44%, Nausea with 21%, Anxiety with 15%, Suicidal Ideation with 8%, Depressed mood with 6%.

Trial Design

2 Treatment Groups

Delayed Psilocybin
1 of 2
Immediate Psilocybin
1 of 2

Active Control

Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Immediate Psilocybin · No Placebo Group · Phase < 1

Immediate Psilocybin
Drug
Experimental Group · 1 Intervention: Psilocybin · Intervention Types: Drug
Delayed Psilocybin
Drug
ActiveComparator Group · 1 Intervention: Psilocybin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~560

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month post session 2

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,073 Previous Clinical Trials
31,017,195 Total Patients Enrolled
Roland R Griffiths, PhDPrincipal InvestigatorJohns Hopkins University
3 Previous Clinical Trials
140 Total Patients Enrolled

Eligibility Criteria

Age 21 - 70 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have given informed consent.
You have no antidepressant medications for approximately five half-lives prior to study enrollment.
You are of childbearing potential and sexually active
You are judged by study team clinicians to be at low risk for suicide.
Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening and is expected to remain stable during participation in the study.

Who else is applying?

What state do they live in?
Maryland33.3%
New Jersey33.3%
California33.3%
What site did they apply to?
Johns Hopkins University School of Medicine100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "I have tried many forms of treatment and still struggle (therapy, medication, alternative medication, EMDR, etc)."
What questions have other patients asked about this trial?
  • "How long do screening visits take? How does compensation work?"
How many prior treatments have patients received?
0100.0%
References