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RecruitingPhase 2

Evaluating the Feasibility, Safety and Efficacy of Psychotherapy Assisted Psilocybin for Treatment of Severe OCD

NCT04882839 · Beersheva Mental Health Center

Recruiting
Status
Accepting participants
Phase 2
Phase
15
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

Obsessive-compulsive disorder (OCD) is a neuropsychiatric disorder characterized by recurrent distressing thoughts and substantial anxiety, accompanied by repetitive behaviors or mental rituals. Individuals with OCD often have diminished quality of life, and functional impairment . The disorder cause high personal, societal and economic costs . Current available treatments for OCD show moderate response rate and high rate of symptom relapse. The purpose of the current study is to explore new alternative options for the treatment of OCD that can widely and continuously benefit patients. Specifically, The aim of this study is to investigate the feasibility, safety and efficacy of psychotherapy assisted psilocybin for treatment of severe OCD. Previous research has shown safety of treatment and high efficacy in reduction of anxiety and depression symptoms. However, only one study has evaluated the use of psilocybin for OCD patients. The protocol includes 15 therapeutic sessions, of which 12 are one-hour sessions for psychological preparation and integration, and three are eight hours' experiential sessions under the influence of psilocybin. The research will include 15 participants diagnosed with severe OCD, with at least one treatment failure. Assessments will be based on comparing ratings of the main outcome measure (Y-BOCS), at baseline, at the middle and at end of treatment. Other assessments will include data on side effects- to evaluate safety, and possible spiritual variables underlying change in symptoms via standardized questionnaires.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Yale-Brown Obsessive-Compulsive Scale (Y-BOCS ) change from baseline

    Measured over Baseline to 6-month follow-up

  • Obsessive-Compulsive Inventory-Revised (OCI-R) change from baseline

    Measured over Baseline to 6-month follow-up

  • Obsessional Beliefs Questionnaire (OBQ-20) change from baseline

    Measured over Baseline to 6-month follow-up

  • Beck Depression Inventory -II (BDI-II) change from baseline

    Measured over Baseline to 6-month follow-up

  • Beck Anxiety Inventory (BAI) change from baseline

    Measured over Baseline to 6-month follow-up

  • Mini International Neuropsychiatric Interview (M.I.N.I.) change from baseline

    Measured over Baseline to end of treatment

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * 1\. DSM-5 diagnosis of OCD established by a trained clinician interview and confirmed by Mini International Neuropsychiatric Interview MINI (edition 7). 2\. Y-BOCS score of 16 or greater at evaluation 3. Treatment resistant- Patients; must have failed at least one medication and/or therapy trial of standard care treatment for OCD. 4\. Age: 18 Years to 65 Years 5. Has been off selective serotonin inhibitors for five half-lives of the drug plus 2 weeks. 6\. Must avoid starting new psychotherapy or psychiatric (medical) treatment during the study, without consulting the study team. 7\. Are willing to refrain from taking any psychiatric medications or recreational drugs during the study period. 8\. Must have a negative pregnancy test at study entry and prior to each experiential/ psychedelic session, if able to bear children, and must agree to use adequate birth control. 9\. Must be willing to sign a medical release form for the investigators to communicate directly with their therapist and doctors to confirm a medication and/or medical history. This is decided on a case by case basis upon the discretion of the PI. 10\. Must provide a contact (relative, spouse, close friend, or other caregiver) who is willing and able to be reached by the Clinical Investigators in the event of a participant becoming suicidal or any another relevant reason. 11\. Are willing to commit to medication dosing, experiential/ psychedelic sessions, psychotherapy and follow-up sessions and to complete the full evaluation. Exclusion Criteria: * 1\. Personal or immediate family history of schizophrenia, bipolar affective disorder, delusion disorder, paranoid disorder, or schizoaffective disorder. 2\. Current (or last 12-month) substance abuse disorder. 3. Unstable neurological or medical condition. 4. Active suicidal intent or last 12-month suicidal attempt. 5. A history of violence, self-harm, or harm to another. 6. Any unstable medical condition that may render study procedures unsafe. 7. Positive urine pregnancy test at the time of screening. 8. Any use of psychedelic drugs within the prior 12 months. 9. Lack of ability to sign Informed consent. Exclusion Criteria during the study 1. Any unusual reaction to any of the study procedures. 2. A participant's request to stop his/ her participation in the study. 3. Positive pregnancy test at any stage prior to the last psychedelic session

Where

1 study site

FacilityCityRegionCountry
Beer Sheva Mental Health CenterBeershebaIsrael

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04882839 on ClinicalTrials.gov →

Last updated in the registry 2025-11-19. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits