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

Sponsor

Parkway Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT00997087

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obsessive Compulsive Disorder	Drug: Flumazenil	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

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.

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: Sugar Pill, Placebo

Drug: Flumazenil

Sublingual daily

Active Comparator: Flumazenil

Drug: Flumazenil

Sublingual daily

Outcome Measures

Primary Outcome Measures

Yale Brown Obsessive Compulsive Score [12 weeks]

Secondary Outcome Measures

Safety will be assessed by Adverse Events, Changes in physical exam, laboratory values. [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

James G.Sullivan, MD, Principal Investigator, Parkway Medical Center

ClinicalTrials.gov Identifier:

NCT00997087

Other Study ID Numbers:

JGS-001

First Posted:

Oct 16, 2009

Last Update Posted:

Apr 22, 2014

Last Verified:

Apr 1, 2014

Keywords provided by James G.Sullivan, MD, Principal Investigator, Parkway Medical Center

OCD

Additional relevant MeSH terms:

Compulsive Personality Disorder

Obsessive-Compulsive Disorder

Flumazenil

Study Results

No Results Posted as of Apr 22, 2014