- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00997087
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
-
-
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
|
Sublingual daily
|
Active Comparator: 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
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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