Pilot Study of Ketamine in Adults With Obsessive-Compulsive Disorder (OCD)

Study Overview
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Brief Summary
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In this study investigators are studying the effects of a drug called ketamine on the symptoms of Obsessive-compulsive disorder (OCD).

Detailed Description
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Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3% of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with SRI treatment, most patients continue to experience significant OCD symptoms, impaired functioning, and diminished quality of life. Recent evidence suggest that a different neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from OCD. In this study the investigators are recruiting patients to receive the drug ketamine, which is thought to modulate the neurotransmitter glutamate through the N-methyl-D-aspartate (NMDA), in a 2-week placebo controlled study.

Official Title
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Understanding the Glutamate System in Adults With Obsessive-Compulsive Disorder With N-methyl-D Aspartate Antagonist Ketamine

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Drug: Ketamine infusion
* Other: Saline


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 Able to provide consent Exclusion Criteria: Psychiatric conditions that make participation unsafe Currently on psychotropic medication Medical conditions that make participation unsafe Allergy to ketamine Any metal in the body

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes | Drug: Ketamine infusion<br>* 0.5mg/kg IV over 40 minutes<br>* Other names: Ketamine hydrochloride;Other: Saline<br>* saline infusion<br>|
| Active Comparator: Group B<br>IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes | Drug: Ketamine infusion<br>* 0.5mg/kg IV over 40 minutes<br>* Other names: Ketamine hydrochloride;Other: Saline<br>* saline infusion<br>|

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. | 1 week | 

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