Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02624596
Recruitment Status : Recruiting
First Posted : December 8, 2015
Last Update Posted : May 8, 2019
Sponsor:
Collaborator:
University of Connecticut
Information provided by (Responsible Party):
Carolyn Rodriguez, Stanford University

Tracking Information
First Submitted Date  ICMJE December 2, 2015
First Posted Date  ICMJE December 8, 2015
Last Update Posted Date May 8, 2019
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2015)
improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: Up to 6 months ]
Change History Complete list of historical versions of study NCT02624596 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2015)
Regional gamma-aminobutyric acid, glutamate/glutamine levels derived from 3T Magnetic Resonance Spectroscopy [ Time Frame: up to 90 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Understanding How Ketamine Brings About Rapid Improvement in OCD
Official Title  ICMJE NMDAR Modulation As a Therapeutic Target and Probe of Neural Dysfunction in OCD
Brief Summary The purpose of this study is to understand how ketamine brings about rapid improvement in Obsessive-Compulsive Disorder (OCD) symptoms.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-Compulsive Disorder
Intervention  ICMJE
  • Drug: Ketamine
    OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion
    Other Name: Ketamine Hydrochloride
  • Drug: Midazolam
    OCD patients in this arm will receive 0.045mg/kg of midazolam - one single infusion
    Other Name: Midazolam Hydrochloride
Study Arms  ICMJE
  • Experimental: Ketamine
    OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion
    Intervention: Drug: Ketamine
  • Active Comparator: Midazolam
    OCD patients in this arm will receive 0.045mg/kg of midazolam - one single infusion
    Intervention: Drug: Midazolam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2015)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jordan Wilson 650-723-4095 ocdresearch@stanford.edu
Contact: Maria Filippou, MD, MBS 650-723-4095 ocdresearch@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02624596
Other Study ID Numbers  ICMJE IRB-34622
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carolyn Rodriguez, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE University of Connecticut
Investigators  ICMJE Not Provided
PRS Account Stanford University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP