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MKET: Understanding How Ketamine Brings About Rapid Improvement in OCD

Sponsor
Stanford University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02624596
Collaborator
University of Connecticut (Other)
120
Enrollment
1
Location
2
Arms
84
Duration (Months)
1.4
Patients Per Site Per Month

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

Study Type:
Interventional
Anticipated 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 :
Jun 1, 2016
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

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:
  • 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 Names:
  • Midazolam Hydrochloride

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    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.
    Responsible Party:
    Carolyn Rodriguez, Principal Investigator, Stanford University
    ClinicalTrials.gov Identifier:
    NCT02624596
    Other Study ID Numbers:
    • IRB-34622
    First Posted:
    Dec 8, 2015
    Last Update Posted:
    May 26, 2022
    Last Verified:
    May 1, 2022
    Keywords provided by Carolyn Rodriguez, Principal Investigator, Stanford University
    OCD
    Additional relevant MeSH terms:
    Obsessive-Compulsive Disorder
    Midazolam
    Ketamine

    Study Results

    No Results Posted as of May 26, 2022