A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of Obsessive Compulsive Disorder (OCD)

This study has been terminated.
(Study completed and data was inconclusive.)
Sponsor:
Information provided by (Responsible Party):
James G.Sullivan, MD, Parkway Medical Center
ClinicalTrials.gov Identifier:
NCT00997087
First received: October 14, 2009
Last updated: April 18, 2014
Last verified: April 2014

October 14, 2009
April 18, 2014
October 2009
December 2012   (final data collection date for primary outcome measure)
Yale Brown Obsessive Compulsive Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00997087 on ClinicalTrials.gov Archive Site
Safety will be assessed by Adverse Events, Changes in physical exam, laboratory values. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of Obsessive Compulsive Disorder
Phase IIa A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of Obsessive Compulsive Disorder.

The purpose of this study is to evaluate the efficacy of flumazenil in the outpatient treatment of Obsessive Compulsive Disorder (OCD).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Obsessive Compulsive Disorder
Drug: Flumazenil
Sublingual daily
  • Placebo Comparator: Sugar Pill, Placebo
    Intervention: Drug: Flumazenil
  • Active Comparator: Flumazenil
    Intervention: Drug: Flumazenil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
19 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00997087
JGS-001
No
James G.Sullivan, MD, Parkway Medical Center
Parkway Medical Center
Not Provided
Principal Investigator: James G Sullivan, MD Parkway Medical Center
Parkway Medical Center
April 2014

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