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Understanding How Ketamine Brings About Rapid Improvement in OCD (MKET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02624596
Recruitment Status : Active, not recruiting
First Posted : December 8, 2015
Last Update Posted : November 13, 2023
Sponsor:
Collaborator:
University of Connecticut
Information provided by (Responsible Party):
Carolyn Rodriguez, Stanford University

Study Description
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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
Obsessive-Compulsive Disorder Drug: Ketamine Drug: Midazolam 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: NMDAR Modulation As a Therapeutic Target and Probe of Neural Dysfunction in OCD
Study Start Date : June 2016
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Ketamine Hydrochloride
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 Name: Midazolam Hydrochloride


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Regional gamma-aminobutyric acid, glutamate/glutamine levels derived from 3T Magnetic Resonance Spectroscopy [ Time Frame: up to 90 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624596


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
University of Connecticut
Investigators
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Principal Investigator: Carolyn I Rodriguez, MD, PhD Stanford University
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Carolyn Rodriguez, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02624596    
Other Study ID Numbers: 34622
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: November 13, 2023
Last Verified: November 2023
Keywords provided by Carolyn Rodriguez, Stanford University:
OCD
Additional relevant MeSH terms:
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Obsessive-Compulsive Disorder
Mental Disorders
Anxiety Disorders
Midazolam
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
 Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents