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

NCT ID: NCT00997087

Last Updated: 2014-04-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2012-12-31

Brief Summary

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

Conditions

Obsessive Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sugar Pill, Placebo

Group Type: PLACEBO_COMPARATOR

Flumazenil

Intervention Type: DRUG

Sublingual daily

Flumazenil

Group Type: ACTIVE_COMPARATOR

Flumazenil

Intervention Type: DRUG

Sublingual daily

Interventions

Flumazenil

Sublingual daily

Intervention Type: DRUG

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parkway Medical Center

OTHER

Sponsor Role: lead

Responsible Party

James G.Sullivan, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James G Sullivan, MD

Role: PRINCIPAL_INVESTIGATOR

Parkway Medical Center

Locations

James G. Sullivan, MD

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

JGS-001

Identifier Type: -

Identifier Source: org_study_id