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

NCT00997087 | Terminated Phase 2

• 1 other identifier: JGS-001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obsessive Compulsive Disorder

Keywords

OCD

Outcome Measures

Primary Outcomes (1)

• Yale Brown Obsessive Compulsive Score

  12 weeks

Secondary Outcomes (1)

• Safety will be assessed by Adverse Events, Changes in physical exam, laboratory values.

  12 weeks

Study Arms (2)

Sugar Pill, Placebo

PLACEBO COMPARATOR

Drug: Flumazenil

Flumazenil

ACTIVE COMPARATOR

Drug: Flumazenil

Interventions

Flumazenil DRUG

Sublingual daily

Flumazenil; Sugar Pill, Placebo

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parkway Medical Center: lead

Study Sites (1)

James G. Sullivan, MD

Birmingham, Alabama, 35215, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Flumazenil

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• James G Sullivan, MD

  Parkway Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: October 16, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 22, 2014

Record last verified: 2014-04

Locations

US (1)