A 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder

May 8, 2014 updated by: Cephalon

A 10-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dosage Study to Evaluate the Efficacy and Safety of Gabitril (up to 16 mg/Day) in the Treatment of Adults With Generalized Anxiety Disorder

The purpose of this study is to evaluate the safety and efficacy of an investigational anti-anxiety medication relative to placebo in patients with generalized anxiety disorder (GAD)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

440

Phase

  • Phase 3

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

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • Pacific Institute For Medical Research, Inc.
      • Newport Beach, California, United States, 92660
        • Pharmacology Research Institute
      • San Diego, California, United States, 92108
        • Affiliated Research Institute
      • San Diego, California, United States, 92123
        • Health Quest Clinical Trials
      • Upland, California, United States, 91786
        • Pacific Clinical Research Medical Group
    • Florida
      • Jacksonville, Florida, United States, 32257
        • UF Behavioral Health Clinic
      • West Palm Beach, Florida, United States, 33407
        • Janus Center For Psychiatric Research
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Atlanta Institute of Medicine & Research - Atlanta Clinic
    • Illinois
      • Edwardsville, Illinois, United States, 62025
        • Cunningham Clinical Research, Llc
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • LSUHSC Anxiety and Mood Disorders Clinic
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
        • Summit Research Network
    • New York
      • Brooklyn, New York, United States, 11235
        • Social Psychiatry Research Inst.
      • New York, New York, United States, 10021
        • Eastside Comprehensive Medical Center
      • New York, New York, United States, 10023
        • Medical and Behavioral Health Research, PC
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Hartford Research Group Ltd.
    • Oregon
      • Salem, Oregon, United States, 97301
        • Oregon Center for Clinical Investigations, Inc.
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • South East Health Consultants, LLC
    • Washington
      • Bellevue, Washington, United States, 98004
        • Northwest Clinical Research Center
    • Wisconsin
      • Brown Deer, Wisconsin, United States, 53223
        • Northbrooke Research

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

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects 18 to 64 years of age (inclusive) will be eligible to participate if they satisfy the DSM-IV-TR criteria for GAD, as well as meeting the required screening and baseline visit scores for a series of psychiatric evaluations (i.e., HAM-A, HADS, MADRS and CGI-S).

Exclusion Criteria:

  • Have been previously unresponsive to two or more adequate courses of pharmacological treatment for GAD
  • Have been diagnosed with any other psychiatric Axis I disorder (except GAD) as a principal diagnosis within the past six months
  • Have been diagnosed with any eating disorder within the past six months
  • Have any history of OCD, psychotic disorder, bipolar disorder or antisocial personality disorder
  • Have any history of alcohol or substance abuse within the past 3 months
  • Have any history of seizures, including febrile seizures
  • Have any history of head trauma associated with loss of consciousness within the past 15 years

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
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction of symptomatology associated with Generalized Anxiety Disorder as assessed by the change from baseline to endpoint in the total score of the HAM-A scale.

Secondary Outcome Measures

Outcome Measure
Assessment of proportion of responders and
patients in remission according to HAM-A scores and CGI ratings by
visit, assessment of the safety and tolerability in patients with GAD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cephalon

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, 2004

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (ESTIMATE)

October 12, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

May 9, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C6671/3032/AX/US

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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