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

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.

NCT Number	NCT04882839
Lead Sponsor	Beersheva Mental Health Center Collaborators: MSICS PHARMA LTD
Conditions	Obsessive-compulsive Disorder
Enrollment	15 participants
Start Date	2024-11-25
Primary Completion	2026-06-01 (estimated)
Study Completion	2027-06-01 (estimated)
Updated on ClinicalTrials.gov	2025-11-19