Extending Ketamine's Effects in OCD With Exposure and Response Prevention (EX/RP)

Study Overview
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Brief Summary
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This study investigates if a single dose of IV Ketamine can rapidly improve Obsessive-Compulsive Disorder (OCD) symptoms and whether these effect can be maintained with a condensed course of a type of Cognitive Behavioral Therapy called Exposure and Response Prevention (EX/RP). You will be compensated for your time and travel. Participants must be between the ages of 18-55.

Official Title
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Extending Ketamine's Effects in Obsessive-Compulsive Disorder (OCD) With Exposure and Response Prevention (EX/RP)

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Drug: Ketamine
* Behavioral: Exposure and Response Prevention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-55 Physically healthy and not currently pregnant Primary Diagnosis of OCD Sufficient severity of symptoms Currently off all psychotropic medication OR Currently on adequate dose of medication for treatment of OCD, but have not achieved at least partial remission Able to provide consent Exclusion Criteria: Psychiatric conditions that make participation unsafe (schizophrenia [either self or first degree relative e.g. siblings, parents], history of violence, severe depression, eating disorder, substance dependence [including nicotine]) Female patients who are either pregnant or nursing Planning to commence EX/RP during the period of the study or those who have completed an adequate dose of EX/RP (defined as 8 or more sessions within 2 months) within 8 weeks prior to enrollment. period of the study Allergy to ketamine Participants for whom being off of medication is not clinically recommended Medical conditions that make participation unsafe (e.g. high blood pressure, head injury) Currently on medications that make participation unsafe

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine, Exposure & Response Prevention<br>0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP) | Drug: Ketamine<br>* 0.5mg/kg IV<br>* Other names: Ketamine hydrochloride;Behavioral: Exposure and Response Prevention<br>* A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.<br>* Other names: EX/RP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale | Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCD