RecruitingPhase 2NCT04882839

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

Open Label, Phase 2 Study for Evaluating the Feasibility, Safety and Efficacy of Psychotherapy Assisted Psilocybin for Treatment of Severe Obsessive Compulsive Disorder (OCD) in Drug and/or Psychotherapy Resistant Patients.


Sponsor

Beersheva Mental Health Center

Enrollment

15 participants

Start Date

Nov 25, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether psilocybin (the active compound in psychedelic mushrooms) combined with supportive psychotherapy can help people with severe, treatment-resistant obsessive-compulsive disorder (OCD) who have not responded to standard medications or therapy. This is an early-phase trial focused on safety and feasibility. **You may be eligible if...** - You are between 18 and 65 years old with a confirmed DSM-5 diagnosis of OCD - Your OCD score (Y-BOCS) is 16 or higher - You have tried and failed at least one standard medication and/or therapy for OCD - You have been off SSRIs for at least the required washout period (five half-lives plus 2 weeks) - You are not starting any new psychiatric medication or therapy during the study - You can provide a contact person (family member or friend) who can be reached in an emergency **You may NOT be eligible if...** - You are currently on SSRIs or other psychiatric medications - You are pregnant or unwilling to use birth control during the study - You are unable to abstain from recreational drugs during the study - You have conditions that would make psychedelic sessions unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTpsychotherapy assisted psilocybin

psychotherapy for patients while under the influence of psilocybin


Locations(1)

Beer Sheva Mental Health Center

Beersheba, Israel

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NCT04882839


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