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

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Parkway Medical Center
• Treatments: Flumazenil

Criteria

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.