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

Sponsor
Beersheva Mental Health Center
Study ID
NCT04882839
Phase
PHASE2
Status
Recruiting
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Conditions

  • Obsessive-compulsive Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • psychotherapy assisted psilocybin — COMBINATION_PRODUCT
    psychotherapy for patients while under the influence of psilocybin

Study Details

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.

Key Dates

First listed
May 12, 2021
Start date
Nov 25, 2024
Status verified
Feb 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Active participants
    Participants undertaking to full therapeutic protocol including psychotherapy sessions and Psilocybin sessions

Primary Outcome Measure

Yale-Brown Obsessive-Compulsive Scale (Y-BOCS ) change from baseline [ Time Frame: Baseline to 6-month follow-up ]

Central Contacts

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