Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Study of Ketamine in Adults With Obsessive-Compulsive Disorder (OCD)

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: NCT01100255
Recruitment Status : Completed
First Posted : April 8, 2010
Results First Posted : October 27, 2016
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE April 5, 2010
First Posted Date  ICMJE April 8, 2010
Results First Submitted Date  ICMJE May 19, 2016
Results First Posted Date  ICMJE October 27, 2016
Last Update Posted Date February 20, 2017
Study Start Date  ICMJE April 2010
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2016)
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale. [ Time Frame: 1 week ]
Patients given 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 was defined as at least a 35% reduction on the YBOCS.
Original Primary Outcome Measures  ICMJE
 (submitted: April 7, 2010)
improvement in severity of OCD symptoms as measured by the YBOCS (Yale-Brown Obsessive Compulsive Scale) [ Time Frame: 2 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of Ketamine in Adults With Obsessive-Compulsive Disorder (OCD)
Official Title  ICMJE Understanding the Glutamate System in Adults With Obsessive-Compulsive Disorder With N-methyl-D Aspartate Antagonist Ketamine
Brief Summary In this study investigators are studying the effects of a drug called ketamine on the symptoms of Obsessive-compulsive disorder (OCD).
Detailed Description Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3% of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with SRI treatment, most patients continue to experience significant OCD symptoms, impaired functioning, and diminished quality of life. Recent evidence suggest that a different neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from OCD. In this study the investigators are recruiting patients to receive the drug ketamine, which is thought to modulate the neurotransmitter glutamate through the N-methyl-D-aspartate (NMDA), in a 2-week placebo controlled study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Obsessive-Compulsive Disorder
Intervention  ICMJE
  • Drug: Ketamine infusion
    0.5mg/kg IV over 40 minutes
    Other Name: Ketamine hydrochloride
  • Other: Saline
    saline infusion
Study Arms  ICMJE
  • Active Comparator: Group A
    0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes
    Interventions:
    • Drug: Ketamine infusion
    • Other: Saline
  • Active Comparator: Group B
    IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes
    Interventions:
    • Drug: Ketamine infusion
    • Other: Saline
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: September 6, 2016)
15
Original Estimated Enrollment  ICMJE
 (submitted: April 7, 2010)
10
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18-55
  • Physically healthy and not currently pregnant
  • Primary Diagnosis of OCD
  • Sufficient severity of symptoms
  • Able to provide consent

Exclusion Criteria:

  • Psychiatric conditions that make participation unsafe
  • Currently on psychotropic medication
  • Medical conditions that make participation unsafe
  • Allergy to ketamine
  • Any metal in the body
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01100255
Other Study ID Numbers  ICMJE 6906R/5883
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carolyn I. Rodriguez, M.D., Ph.D. Columbia-NYSPI-RFMH
PRS Account New York State Psychiatric Institute
Verification Date January 2017

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