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Randomized Controlled Trial of Intranasal Ketamine vs. Intranasal Midazolam in Individuals With 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: NCT02206776
Recruitment Status : Terminated (poor tolerability and low enrollment rate)
First Posted : August 1, 2014
Results First Posted : February 23, 2017
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE July 31, 2014
First Posted Date  ICMJE August 1, 2014
Results First Submitted Date  ICMJE January 3, 2017
Results First Posted Date  ICMJE February 23, 2017
Last Update Posted Date May 3, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2017)
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale. [ Time Frame: Baseline and 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: July 31, 2014)
  • Improvement in severity of Obsessive Compulsive Disorder symptoms as measured by the Yale-Brown Obsessive Compulsive Scale [ Time Frame: 3 Weeks ]
  • Improvement in severity of Obsessive Compulsive symptoms as measured by the Visual Analog Scale [ Time Frame: 3 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 Randomized Controlled Trial of Intranasal Ketamine vs. Intranasal Midazolam in Individuals With OCD
Official Title  ICMJE Randomized Controlled Trial of Intranasal Ketamine vs. Intranasal Midazolam in Individuals With Obsessive Compulsive Disorder (OCD)
Brief Summary Obsessive-compulsive disorder (OCD) is a common illness that causes significant distress and impairment. Currently, serotonin reuptake inhibitors (SRIs) are the only medications that are FDA-approved to treat OCD. Unfortunately, SRIs can take a long time to work (2-3 months), and even then they usually only partially reduce OCD symptoms. The present study, will test if intranasal ketamine is feasible to use and can reduce OCD symptoms significantly more than a comparison medication called midazolam. Therefore, you may or may not receive ketamine as part of this study. Results from this study will allow doctors and researchers to better understand if you and others with OCD may respond to this class of medications.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-Compulsive Disorder
Intervention  ICMJE
  • Drug: Intranasal Ketamine
    A single dose of intranasal ketamine up to 50 mg
    Other Name: Ketamine Hydrochloride
  • Drug: Intranasal Midazolam
    A single dose of intranasal Midazolam up to 4 mg
Study Arms  ICMJE
  • Placebo Comparator: Midazolam
    A single dose of intranasal midazolam up to 4 mg
    Intervention: Drug: Intranasal Midazolam
  • Experimental: Ketamine
    A single dose of intranasal ketamine up to 50 mg
    Intervention: Drug: Intranasal Ketamine
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 Terminated
Actual Enrollment  ICMJE
 (submitted: January 3, 2017)
2
Original Estimated Enrollment  ICMJE
 (submitted: July 31, 2014)
50
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 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
  • For all patients on medications, medications dose must be stable for at least 6 weeks prior to enrollment. Must discuss with Dr. current medications and doses.
  • Able to provide consent

Exclusion Criteria:

  • First degree relative with schizophrenia
  • Psychiatric conditions that would make participation unsafe determined by study doctor
  • Female patients who are either pregnant or nursing
  • Planning to start EX/RP during the period of the study or those who have completed an adequate dose of EX/RP (defined as 8 or more sessions within 2 months) within 8 weeks prior to enrollment.
  • Nasal obstruction or history of nasal surgery
  • Currently on psychotropic medication or other medication likely to interact with the glutamate system
  • Medical conditions that make participation unsafe
  • Allergy or intolerance to ketamine or midazolam
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 NCT02206776
Other Study ID Numbers  ICMJE #6952
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party New York State Psychiatric Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE New York State Psychiatric Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carolyn I Rodriguez, M.D., Ph.D. Stanford University
PRS Account New York State Psychiatric Institute
Verification Date March 2017

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