- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02624596
Understanding How Ketamine Brings About Rapid Improvement in OCD (MKET)
August 11, 2026 updated by: Carolyn Rodriguez, Stanford University
NMDAR Modulation As a Therapeutic Target and Probe of Neural Dysfunction in OCD
The purpose of this study is to understand how ketamine brings about rapid improvement in Obsessive-Compulsive Disorder (OCD) symptoms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ketamine
OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion
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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
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OCD patients in this arm will receive 0.045mg/kg of midazolam - one single infusion
Other Names:
|
What is the study measuring?
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)
Time Frame: 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.
|
Up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Regional gamma-aminobutyric acid, glutamate/glutamine levels derived from 3T Magnetic Resonance Spectroscopy
Time Frame: up to 90 minutes
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up to 90 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Carolyn I Rodriguez, MD, PhD, Stanford University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 16, 2016
Primary Completion (Actual)
June 20, 2021
Study Completion (Actual)
June 28, 2021
Study Registration Dates
First Submitted
December 2, 2015
First Submitted That Met QC Criteria
December 7, 2015
First Posted (Estimated)
December 8, 2015
Study Record Updates
Last Update Posted (Actual)
August 13, 2026
Last Update Submitted That Met QC Criteria
August 11, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Anxiety Disorders
- Obsessive-Compulsive Disorder
- Organic Chemicals
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Hydrocarbons
- Cyclohexanes
- Cycloparaffins
- Hydrocarbons, Alicyclic
- Hydrocarbons, Cyclic
- Benzazepines
- Benzodiazepines
- Midazolam
- Ketamine
Other Study ID Numbers
- 34622
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.