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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Parkway Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
James G.Sullivan, MD, Parkway Medical Center
ClinicalTrials.gov Identifier:
NCT00997087
First received: October 14, 2009
Last updated: May 30, 2012
Last verified: October 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Flumazenil
U.S. FDA Resources

Further study details as provided by Parkway Medical Center:

Primary Outcome Measures:
  • Yale Brown Obsessive Compulsive Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 40
Study Start Date: October 2009
Estimated Study Completion Date: February 2013
Estimated 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

Ages Eligible for Study:   19 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997087

Locations
United States, Alabama
James G. Sullivan, MD Recruiting
Birmingham, Alabama, United States, 35215
Contact: Melanie Foster     205-815-5000 ext 159     mfoster.crc@gmail.com    
Contact: James Sullivan, MD     205-815-5000 ext 159     dgregs@gmail.com    
Principal Investigator: James G Sullivan, MD            
Sponsors and Collaborators
Parkway Medical Center
Investigators
Principal Investigator: James G Sullivan, MD Parkway Medical Center
  More Information

No publications provided

Responsible Party: James G.Sullivan, MD, Principal Investigator, Parkway Medical Center
ClinicalTrials.gov Identifier: NCT00997087     History of Changes
Other Study ID Numbers: JGS-001
Study First Received: October 14, 2009
Last Updated: May 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Parkway Medical Center:
OCD

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

ClinicalTrials.gov processed this record on May 22, 2013