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

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 psilocybin-assisted psychotherapy for treatment of severe OCD. 

Topic Obsessive-Compulsive Disorder
Compound Psilocybin
Country Israel
Visit trial
Status Not yet recruiting
Results Published
Start date 12 January 2021
End date 12 January 2025
Chance of happening 90%
Phase Phase I Phase II
Design Open
Type Interventional
Generation First
Participants 15
Sex All
Age 18- 65
Therapy No

Trial 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.

NCT Number NCT04882839

Sponsors & Collaborators

Beersheva Mental Health Center
This company doesn't have a full profile yet, it is linked to a clinical trial.

Measures Used

Yale-Brown Obsessive Compulsive Scale
The Yale Brown Obsessive-Compulsive Scale (Y-BOSC) is considered the gold-standard to assess OCD severity. The scale consists of ten items and measures the severity and type of symptoms in people with OCD over the previous seven days. The scale is used at initial diagnosis as well as during follow up sessions after treatment. The scores range from 0 to 4, with higher scores indicating greater symptoms of OCD severity.

Beck Depression Inventory
The Beck Depression Inventory (BDI) contains 21 self-report items, completed using a multiple-choice format. Scores range from 0-63 with higher scores associated with more severe depression.

5-Dimensional Altered States of Consciousness Questionnaire
The 5D-ASC scale measures altered states of consciousness and contains 94 items (visual analog scales).

Obsessive Compulsive Inventory-Revised
The OCI-R is an 18-item self-report questionnaire based on the earlier 84-item OCI. Participants rate the degree to which they are bothered or distressed by specific OCD symptoms in the past month.

Data attribution

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