Status:
TERMINATED
A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of Obsessive Compulsive Disorder
Lead Sponsor:
Parkway Medical Center
Conditions:
Obsessive Compulsive Disorder
Eligibility:
All Genders
19-60 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy of flumazenil in the outpatient treatment of Obsessive Compulsive Disorder (OCD).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00997087
Start Date
October 1 2009
End Date
December 1 2012
Last Update
April 22 2014
Active Locations (1)
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1
James G. Sullivan, MD
Birmingham, Alabama, United States, 35215