MKET: Understanding How Ketamine Brings About Rapid Improvement in OCD
Study Details
Study Description
Brief Summary
The purpose of this study is to understand how ketamine brings about rapid improvement in Obsessive-Compulsive Disorder (OCD) symptoms.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Ketamine OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion |
Drug: Ketamine
OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion
Other Names:
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Active Comparator: Midazolam OCD patients in this arm will receive 0.045mg/kg of midazolam - one single infusion |
Drug: Midazolam
OCD patients in this arm will receive 0.045mg/kg of midazolam - one single infusion
Other Names:
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Outcome Measures
Primary Outcome Measures
- improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) [Up to 6 months]
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.
Secondary Outcome Measures
- Regional gamma-aminobutyric acid, glutamate/glutamine levels derived from 3T Magnetic Resonance Spectroscopy [up to 90 minutes]
Eligibility Criteria
Criteria
Inclusion Criteria for participants with OCD:
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age 18-65
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Primary diagnosis of OCD
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Sufficient severity of OCD symptoms
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ability to tolerate a treatment-free period
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capacity to provide informed consent
Inclusion criteria for healthy controls:
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ages 18-65
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capacity to provide informed consent
Exclusion criteria for participants with OCD:
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Psychiatric or medical conditions that make participation unsafe
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pregnant or nursing females
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concurrent use of any medications that might increase the risk of participation (e.g. drug interactions)
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presence of metallic device or dental braces
Exclusion criteria for healthy controls:
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any current or lifetime psychiatric diagnosis
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pregnant or nursing females
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major medical or neurological problem
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presence of metallic device or dental braces
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Stanford University | Stanford | California | United States | 94305 |
Sponsors and Collaborators
- Stanford University
- University of Connecticut
Investigators
- Principal Investigator: Carolyn I Rodriguez, MD, PhD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- IRB-34622