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

NCT04882839 | Recruiting Phase 2

• 2 other identifiers: 0003-20-MHC2MOH_2025-02-20_009663
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obsessive-compulsive Disorder

Keywords

obsessive compulsive disorder; psilocybin

Outcome Measures

Primary Outcomes (6)

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

  severity of OCD symptoms- change from baseline

  Baseline to 6-month follow-up

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

  OCD symptoms

  Baseline to 6-month follow-up

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

  obsessive Beliefs

  Baseline to 6-month follow-up

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

  depression symptoms, will be measured by the Beck Depression Inventory

  Baseline to 6-month follow-up

• Beck Anxiety Inventory (BAI) change from baseline

  anxiety symptoms will be measured by the Beck Anxiety Inventory

  Baseline to 6-month follow-up

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

  psychopathological status will be measured by the Mini International Neuropsychiatric Interview

  Baseline to end of treatment

Secondary Outcomes (6)

• 5-Dimension - Altered States of Consciousness (5D-ASC)

  7 hours after drug administration

• Mystical Experience Questionnaire (MEQ)

  7 hours after drug administration

• Emotional Breakthrough Inventory (EBI)

  Morning after drug administration

• Persisting Effects Questionnaire (PEQ)

  Baseline to 6-month follow-up

• Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)

  Baseline to 6-month follow-up

Study Arms (1)

Active participants

EXPERIMENTAL

Participants undertaking to full therapeutic protocol including psychotherapy sessions and Psilocybin sessions

Combination Product: psychotherapy assisted psilocybin

Interventions

psychotherapy assisted psilocybin COMBINATION_PRODUCT

psychotherapy for patients while under the influence of psilocybin

Active participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. DSM-5 diagnosis of OCD established by a trained clinician interview and confirmed by Mini International Neuropsychiatric Interview MINI (edition 7).
• \. 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.
• \. Age: 18 Years to 65 Years 5. Has been off selective serotonin inhibitors for five half-lives of the drug plus 2 weeks.
• \. Must avoid starting new psychotherapy or psychiatric (medical) treatment during the study, without consulting the study team.
• \. Are willing to refrain from taking any psychiatric medications or recreational drugs during the study period.
• \. 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.
• \. 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.
• \. 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.
• \. Are willing to commit to medication dosing, experiential/ psychedelic sessions, psychotherapy and follow-up sessions and to complete the full evaluation.

You may not qualify if:

• \. Personal or immediate family history of schizophrenia, bipolar affective disorder, delusion disorder, paranoid disorder, or schizoaffective disorder.
• Any unusual reaction to any of the study procedures.
• A participant's request to stop his/ her participation in the study.
• Positive pregnancy test at any stage prior to the last psychedelic session

Sponsors & Collaborators

• Beersheva Mental Health Center: lead
• MSICS PHARMA LTD: collaborator

Study Sites (1)

Beer Sheva Mental Health Center

Beersheba, 8461144, Israel

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Oded Arbel, MD

  Beersheva Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oded Arbel, Dr.

CONTACT

+972506576691; oded.arbel@gmail.com

Dor Danan, MD PhD

CONTACT

+972524782140; doriandanan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Head of Day Care Unit

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: May 12, 2021
• Study Start: November 25, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)