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Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder (IVKetamine)

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: NCT01371110
Recruitment Status : Terminated (no funding)
First Posted : June 10, 2011
Results First Posted : October 2, 2017
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Wayne Goodman MD, Baylor College of Medicine

Tracking Information
First Submitted Date  ICMJE June 7, 2011
First Posted Date  ICMJE June 10, 2011
Results First Submitted Date  ICMJE April 18, 2017
Results First Posted Date  ICMJE October 2, 2017
Last Update Posted Date January 18, 2018
Study Start Date  ICMJE June 2012
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2017)
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCCS) Rating OCD Symptom Severity From Baseline to 24-hours After Ketamine Administration [ Time Frame: Baseline and 24 Hours ]
The primary efficacy outcome is change in the Y-BOCCS rating score on a scale from baseline to 24 hrs post-administration of ketamine. The 10 Y-BOCCS items are each scored on a four-point scale from 0 = "no symptoms" to 4 = "extreme symptoms." The sum of the first five items is a severity index for obsessions. The sum of the last five an index for compulsions. A translation of total score into an approximate index of overall severity is: 0-7 - subclinical; 8-15 - mild; 16-23 - moderate; 24-31 - severe; 32-40 - extreme.
Original Primary Outcome Measures  ICMJE
 (submitted: June 9, 2011)
Change in Y-BOCS from baseline to 24-hours after ketamine administration [ Time Frame: 24 Hours ]
The primary efficacy outcome is change in the Y-BOCCS from baseline to 24 hrs post-administration of ketamine.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2017)
Percentage of Patients Who Meet Response and Remission [ Time Frame: up to 14 days ]
Percentage of patients who meet response (defined as 25% reduction in Y-BOCCS score) and remission (defined as Y-BOCS score ≤10) criteria at 24 hrs post-infusion and durability of efficacy up to two weeks after administration. Assessments will be performed 24, 48 and 72 hrs post-infusion and after 7, 10, and 14 days.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2011)
Percentage of patients who meet response and remission [ Time Frame: 24 Hours, 48 Hours, 72 Hours, 7 Days, 10 days, 14 days ]
Percentage of patients who meet response (defined as 25% reduction in Y-BOCCS score) and remission (defined as Y-BOCS score ≤10) criteria at 24 hrs post-infusion and durability of efficacy up to two weeks after administration. Assessments will be performed 24, 48 and 72 hrs post-infusion and after 7, 10, and 14 days.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder
Official Title  ICMJE Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder
Brief Summary Obsessive-Compulsive Disorder (OCD) is a chronic and disabling anxiety disorder and a leading cause of worldwide disability that presents a significant public health problem. Treatment options are limited and many OCD patients fail to respond completely or quickly to standard treatments, including pharmacotherapy and psychotherapy. At this time, patients who fail to respond to treatment with serotonergic drugs, augmenting antipsychotic agents, and behavioral therapy, have few additional treatment options aside from deep brain stimulation. Therefore, despite advances in current pharmacological and behavioral treatments, and the utility of serotonergic drugs, it is likely that other neurotransmitter systems are involved and that targeting these systems may increase treatment efficacy. Despite little evidence for serotonergic dysfunction in OCD, there is significant evidence that glutamatergic dysregulation may contribute to the development and progression of the disorder. Also, preliminary studies suggest that glutamatergic modulators (i.e. riluzole and d-cycloserine), particularly agents acting at the NMDA receptor (i.e. memantine), may be useful in OCD. The NMDA antagonist, ketamine, has demonstrated rapid effects when delivered as a single intravenous (IV) dose in depressed patients. Therefore, the objective of the current study is to investigate the safety and efficacy of a single dose of IV ketamine in treatment-resistant OCD.
Detailed Description This study will test the safety and efficacy of a single intravenous (IV) dose of the N-methyl-D-aspartate (NMDA) glutamate receptor antagonist, ketamine, in treatment-resistant OCD.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obsessive Compulsive Disorder
Intervention  ICMJE
  • Drug: Ketamine
    Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter.
    Other Name: ketamine hydrochloride
  • Drug: Midazolam
    Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant.
Study Arms  ICMJE
  • Active Comparator: Ketamine
    Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride
    Intervention: Drug: Ketamine
  • Sham Comparator: Midazolam
    Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam
    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 Terminated
Actual Enrollment  ICMJE
 (submitted: October 13, 2015)
3
Original Estimated Enrollment  ICMJE
 (submitted: June 9, 2011)
12
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female patients, 21-65 years
  • Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study
  • Primary diagnosis of Obsessive-Compulsive Disorder as assessed by the SCID-P, with symptoms for at least 1 year (Patients who meet criteria for OCD will be required to be medication free or have all psychotropics aside from SSRIs and as needed benzodiazepines tapered. Prior to study entry, proscribed psychotropics are tapered, and subjects must be on the same SSRI for at least 8 weeks with no change in dose for at least 4 weeks and throughout the study. However, subjects will be allowed to use benzodiazepines as needed throughout the study.)
  • History of a failure to respond to at least two (2) adequate pharmacotherapy trials and CBT for OCD
  • Subjects must have scored ≥ 21 on the Y-BOCS at Screening, and to not be in remission on Treatment Day #1, and Treatment Day #2
  • Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document
  • Subjects must be able to identify a family member, physician, or friend who will participate in the Treatment Contract and serve as an emergency contact.

Exclusion Criteria:

  • Women who plan to become pregnant within the next six months, are pregnant or are breast-feeding
  • Non-English speakers
  • Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease
  • Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG
  • Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, mental retardation, or pervasive developmental disorders
  • Current evidence of psychotic or manic symptoms
  • Drug or alcohol abuse or dependence within the preceding 6 months
  • Lifetime abuse or dependence on ketamine or phencyclidine
  • Patients judged by study investigator to be at high risk for suicide
  • Current use of psychotropics other than SSRIs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older 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 NCT01371110
Other Study ID Numbers  ICMJE GCO 11-1113
HSM#11-01536 ( Other Identifier: THE MOUNT SINAI HEALTH SYSTEM )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Wayne Goodman MD, Baylor College of Medicine
Original Responsible Party Dr. Wayne Goodman, MD, Mount Sinai School of Medicine
Current Study Sponsor  ICMJE Wayne Goodman MD
Original Study Sponsor  ICMJE Goodman, Wayne, M.D.
Collaborators  ICMJE Icahn School of Medicine at Mount Sinai
Investigators  ICMJE
Principal Investigator: Wayne K Goodman, MD Baylor College of Medicine (previously Icahn School of Medicine at Mount Sinai)
Principal Investigator: Kyle Lapidus, MD (previously Icahn School of Medicine at Mount Sinai)
PRS Account Baylor College of Medicine
Verification Date January 2018

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