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

This study has been terminated.
(Study completed and data was inconclusive.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00997087
First Posted: October 16, 2009
Last Update Posted: April 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
James G.Sullivan, MD, Parkway Medical Center
  Purpose
The purpose of this study is to evaluate the efficacy of flumazenil in the outpatient treatment of Obsessive Compulsive Disorder (OCD).

Condition Intervention Phase
Obsessive Compulsive Disorder Drug: Flumazenil Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase IIa A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of Obsessive Compulsive Disorder.

Resource links provided by NLM:


Further study details as provided by James G.Sullivan, MD, Parkway Medical Center:

Primary Outcome Measures:
  • Yale Brown Obsessive Compulsive Score [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Safety will be assessed by Adverse Events, Changes in physical exam, laboratory values. [ Time Frame: 12 weeks ]

Enrollment: 11
Study Start Date: October 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar Pill, Placebo Drug: Flumazenil
Sublingual daily
Active Comparator: Flumazenil Drug: Flumazenil
Sublingual daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997087


Locations
United States, Alabama
James G. Sullivan, MD
Birmingham, Alabama, United States, 35215
Sponsors and Collaborators
Parkway Medical Center
Investigators
Principal Investigator: James G Sullivan, MD Parkway Medical Center
  More Information

Responsible Party: James G.Sullivan, MD, Principal Investigator, Parkway Medical Center
ClinicalTrials.gov Identifier: NCT00997087     History of Changes
Other Study ID Numbers: JGS-001
First Submitted: October 14, 2009
First Posted: October 16, 2009
Last Update Posted: April 22, 2014
Last Verified: April 2014

Keywords provided by James G.Sullivan, MD, Parkway Medical Center:
OCD

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Flumazenil
Antidotes
Protective Agents
Physiological Effects of Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action