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

Obsessive Compulsive Disorder Clinical Trial

— OCD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00997087
• Other study ID #: JGS-001
• Status: Terminated
• Phase: Phase 2
• First received: October 14, 2009
• Last updated: April 18, 2014
• Start date: October 2009
• Est. completion date: December 2012

Study information

• Verified date: April 2014
• Source: Parkway Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

Drug:
• Flumazenil
Sublingual daily

Locations

Country	Name	City	State
United States	James G. Sullivan, MD	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Parkway Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale Brown Obsessive Compulsive Score		12 weeks	No
Secondary	Safety will be assessed by Adverse Events, Changes in physical exam, laboratory values.		12 weeks	Yes