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

April 18, 2014 updated by: James G.Sullivan, MD, Parkway Medical Center

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35215
        • James G. Sullivan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Sugar Pill, Placebo
Drug: Flumazenil
Sublingual daily
Active Comparator: Flumazenil
Drug: Flumazenil
Sublingual daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Yale Brown Obsessive Compulsive Score
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parkway Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 14, 2009

First Submitted That Met QC Criteria

October 15, 2009

First Posted (Estimate)

October 16, 2009

Study Record Updates

Last Update Posted (Estimate)

April 22, 2014

Last Update Submitted That Met QC Criteria

April 18, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JGS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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