Understanding How Ketamine Brings About Rapid Improvement in OCD

Study Overview
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Brief Summary
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The purpose of this study is to understand how ketamine brings about rapid improvement in Obsessive-Compulsive Disorder (OCD) symptoms.

Detailed Description
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Obsessive-Compulsive Disorder (OCD) is a chronic and disabling disorder that costs the economy over $2 billion annually and represents a significant public health problem. This study aims to build on our discovery that a potent NMDA receptor antagonist, ketamine, has rapid (in hours) and robust therapeutic effects in OCD. The proposed projects test the acute mechanism of action of ketamine at the level of molecules, circuits, and network synchrony to determine how NMDA receptor antagonism modifies the underlying pathology of OCD to relieve repetitive thoughts and behaviors.

Official Title
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NMDAR Modulation As a Therapeutic Target and Probe of Neural Dysfunction in OCD

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Drug: Ketamine
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for participants with OCD: age 18-65 Primary diagnosis of OCD Sufficient severity of OCD symptoms ability to tolerate a treatment-free period capacity to provide informed consent Inclusion criteria for healthy controls: ages 18-65 capacity to provide informed consent Exclusion criteria for participants with OCD: Psychiatric or medical conditions that make participation unsafe pregnant or nursing females concurrent use of any medications that might increase the risk of participation (e.g. drug interactions) presence of metallic device or dental braces Exclusion criteria for healthy controls: any current or lifetime psychiatric diagnosis pregnant or nursing females major medical or neurological problem presence of metallic device or dental braces

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine<br>OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion | Drug: Ketamine<br>* OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion<br>* Other names: Ketamine Hydrochloride;|
| Active Comparator: Midazolam<br>OCD patients in this arm will receive 0.045mg/kg of midazolam - one single infusion | Drug: Midazolam<br>* OCD patients in this arm will receive 0.045mg/kg of midazolam - one single infusion<br>* Other names: Midazolam Hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) | Improvement in OCD severity is measured by the 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 is defined as at least a 35% reduction on the YBOCS. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional gamma-aminobutyric acid, glutamate/glutamine levels derived from 3T Magnetic Resonance Spectroscopy |  | up to 90 minutes | 

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