Actively Recruiting
Evaluating the Feasibility, Safety and Efficacy of Psychotherapy Assisted Psilocybin for Treatment of Severe OCD
Led by Beersheva Mental Health Center · Updated on 2025-11-19
15
Participants Needed
1
Research Sites
131 weeks
Total Duration
On this page
Sponsors
B
Beersheva Mental Health Center
Lead Sponsor
M
MSICS PHARMA LTD
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Evaluating the Feasibility, Safety and Efficacy of Psychotherapy Assisted Psilocybin for Treatment of Severe OCD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of OCD by a trained clinician and confirmed by Mini International Neuropsychiatric Interview (MINI)
- Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of 16 or greater
- Treatment resistant, having failed at least one medication or therapy for OCD
- Age between 18 and 65 years
- Off selective serotonin reuptake inhibitors (SSRIs) for at least five half-lives plus two weeks
- Willing to avoid starting new psychotherapy or psychiatric treatments during the study without consulting the study team
- Willing to refrain from taking psychiatric medications or recreational drugs during the study
- Negative pregnancy test at study entry and before each psilocybin session if able to bear children, with agreement to use birth control
- Willing to sign a medical release form for communication with therapists and doctors as needed
- Able to provide a contact person reachable by investigators in case of emergency
- Committed to completing medication dosing, psilocybin sessions, psychotherapy, and follow-up assessments
You will not qualify if you...
- Personal or immediate family history of schizophrenia, bipolar disorder, delusion disorder, paranoid disorder, or schizoaffective disorder
- Current or past 12-month substance abuse disorder
- Unstable neurological or medical conditions
- Active suicidal intent or suicide attempt in the past 12 months
- History of violence, self-harm, or harm to others
- Any unstable medical condition making study procedures unsafe
- Positive pregnancy test at screening or any time before the last psilocybin session
- Use of psychedelic drugs within the past 12 months
- Unable to provide informed consent
- Any unusual reaction to study procedures or withdrawing consent during the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beer Sheva Mental Health Center
Beersheba, Israel, 8461144
Actively Recruiting
Research Team
O
Oded Arbel, Dr.
CONTACT
D
Dor Danan, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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