Clinical trial NCT00997087: A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of Obsessive Compulsive Disorder
Official title: Phase IIa A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of Obsessive Compulsive Disorder.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Obsessive Compulsive Disorder
Keywords: OCD
Lead sponsor: Parkway Medical Center
Sponsor class: OTHER
First posted: 2009-10-16
Enrollment: 11
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Yale Brown Obsessive Compulsive Score
timeFrame: 12 weeks
Secondary outcomes:
measure: Safety will be assessed by Adverse Events, Changes in physical exam, laboratory values.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: James G. Sullivan, MD
state: Alabama
Study officials:
affiliation: Parkway Medical Center
name: James G Sullivan, MD
role: PRINCIPAL_INVESTIGATOR
References: