Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Extending Ketamine's Effects in OCD With Exposure and Response Prevention (EX/RP)

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: NCT02062658
Recruitment Status : Completed
First Posted : February 14, 2014
Results First Posted : October 27, 2016
Last Update Posted : December 29, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE February 12, 2014
First Posted Date  ICMJE February 14, 2014
Results First Submitted Date  ICMJE May 19, 2016
Results First Posted Date  ICMJE October 27, 2016
Last Update Posted Date December 29, 2016
Study Start Date  ICMJE December 2013
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: 2 weeks ]
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: February 12, 2014)
Improvement in severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: 4 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 Extending Ketamine's Effects in OCD With Exposure and Response Prevention (EX/RP)
Official Title  ICMJE Extending Ketamine's Effects in Obsessive-Compulsive Disorder (OCD) With Exposure and Response Prevention (EX/RP)
Brief Summary This study investigates if a single dose of IV Ketamine can rapidly improve Obsessive-Compulsive Disorder (OCD) symptoms and whether these effect can be maintained with a condensed course of a type of Cognitive Behavioral Therapy called Exposure and Response Prevention (EX/RP). You will be compensated for your time and travel. Participants must be between the ages of 18-55.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-Compulsive Disorder
Intervention  ICMJE
  • Drug: Ketamine
    0.5mg/kg IV
    Other Name: Ketamine hydrochloride
  • Behavioral: Exposure and Response Prevention
    A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.
    Other Name: EX/RP
Study Arms  ICMJE Experimental: Ketamine, Exposure & Response Prevention
0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)
Interventions:
  • Drug: Ketamine
  • Behavioral: Exposure and Response Prevention
Publications * Rodriguez CI, Wheaton M, Zwerling J, Steinman SA, Sonnenfeld D, Galfalvy H, Simpson HB. Can exposure-based CBT extend the effects of intravenous ketamine in obsessive-compulsive disorder? an open-label trial. J Clin Psychiatry. 2016 Mar;77(3):408-9. doi: 10.4088/JCP.15l10138.

*   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)
10
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2014)
15
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
  • Currently off all psychotropic medication OR
  • Currently on adequate dose of medication for treatment of OCD, but have not achieved at least partial remission
  • Able to provide consent

Exclusion Criteria:

  • Psychiatric conditions that make participation unsafe (schizophrenia [either self or first degree relative e.g. siblings, parents], history of violence, severe depression, eating disorder, substance dependence [including nicotine])
  • Female patients who are either pregnant or nursing
  • Planning to commence 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.

period of the study

  • Allergy to ketamine
  • Participants for whom being off of medication is not clinically recommended
  • Medical conditions that make participation unsafe (e.g. high blood pressure, head injury)
  • Currently on medications that make participation unsafe
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 NCT02062658
Other Study ID Numbers  ICMJE #6811
K23MH092434 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: H Blair Simpson, MD, PhD Columbia-NYSPI-RFMH
PRS Account New York State Psychiatric Institute
Verification Date November 2016

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