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A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of 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: NCT00997087
Recruitment Status : Terminated (Study completed and data was inconclusive.)
First Posted : October 16, 2009
Last Update Posted : April 22, 2014
Sponsor:
Information provided by (Responsible Party):
James G.Sullivan, MD, Parkway Medical Center

Tracking Information
First Submitted Date  ICMJE October 14, 2009
First Posted Date  ICMJE October 16, 2009
Last Update Posted Date April 22, 2014
Study Start Date  ICMJE October 2009
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2009)
Yale Brown Obsessive Compulsive Score [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2009)
Safety will be assessed by Adverse Events, Changes in physical exam, laboratory values. [ Time Frame: 12 weeks ]
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 A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of Obsessive Compulsive Disorder
Official Title  ICMJE Phase IIa A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of Obsessive Compulsive Disorder.
Brief Summary The purpose of this study is to evaluate the efficacy of flumazenil in the outpatient treatment of Obsessive Compulsive Disorder (OCD).
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, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obsessive Compulsive Disorder
Intervention  ICMJE Drug: Flumazenil
Sublingual daily
Study Arms  ICMJE
  • Placebo Comparator: Sugar Pill, Placebo
    Intervention: Drug: Flumazenil
  • Active Comparator: Flumazenil
    Intervention: Drug: Flumazenil
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: April 18, 2014)
11
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2009)
40
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able to understand and provide written informed consent.
  • Age 19-60, inclusive.
  • Diagnosis documented according to DSM-IV of OCD.
  • Exhibits moderate to severe OCD symptoms and a minimum score of 16 or greater -YBOCS at screening.
  • Willing and able to discontinue current medications taken for the treatment of OCD.
  • Able to attend and participate in all study visits.
  • Agree to continue if in current psychosocial therapy throughout the remainder of the study.
  • If female and of child-bearing potential, willing to use an acceptable method of birth control for the duration of the study.
  • If male, willing to use barrier method of birth control or had previous vasectomy.

Exclusion Criteria:

  • Have other DSM-IV Axis I diagnoses.
  • Pregnant as confirmed by urine analysis, or lactating, or unwilling to comply with use of contraception.
  • Unwilling or unable to washout (discontinue) from prohibited medications such as antidepressants (See Appendix 2).
  • Depression symptoms with a score of 15 or greater on the MADRS at screening.
  • Current suicidal ideation or plan within the last 30 days.
  • Have a medical condition which, in the opinion of the investigator, makes study participation unsafe or noncompliant.
  • Abnormal physical exam or laboratory values which, in the opinion of the investigator, makes study participation unsafe or may require introduction of concomitant medications during the course of the study.
  • Benzodiazepine and/or similar sedative-hypnotic or anxiolytic use or abuse within 15 days of potential flumazenil treatment: patients must not be habituated to benzodiazepines and must provide a urine sample that is negative for benzodiazepines, must not be taking supra-therapeutic doses of zolpidem (AmbienTM) or zaleplon (SonataTM ). (See Appendix 2).
  • Patients who are taking Phenobarbital for a documented seizure disorder can be admitted. Patients with a seizure disorder being managed with clonazepam (KlonopinTM ) or other benzodiazepine cannot participate, patients must not be taking TCA, lithium, methylxanthines, isoniazid, propoxyphene, monoamine oxidase inhibitors, bupropion HCL, and cyclosporine. (See Appendix 2).
  • Previously treated with flumazenil for OCD.
  • AIDS as determined by self-report.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 60 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 NCT00997087
Other Study ID Numbers  ICMJE JGS-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James G.Sullivan, MD, Parkway Medical Center
Study Sponsor  ICMJE Parkway Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James G Sullivan, MD Parkway Medical Center
PRS Account Parkway Medical Center
Verification Date April 2014

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