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

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

Official Title
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Phase IIa A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of Obsessive Compulsive Disorder.

Conditions
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Obsessive Compulsive Disorder

Intervention / Treatment
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* Drug: Flumazenil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sugar Pill, Placebo<br> | Drug: Flumazenil<br>* Sublingual daily<br>|
| Active Comparator: Flumazenil<br> | Drug: Flumazenil<br>* Sublingual daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale Brown Obsessive Compulsive Score |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be assessed by Adverse Events, Changes in physical exam, laboratory values. |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCD