A 10-Week Study for Efficacy and Safety Study 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
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Birmingham Research Group
    • California
      • Beverly Hills, California, United States, 90210
        • Southwestern Research Institute
      • Northridge, California, United States, 91324
        • Pharmacology Research Institute
      • Orange, California, United States, 92868
        • Pacific Clinical Research
    • Georgia
      • Smyrna, Georgia, United States, 30080
        • Carman Research
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Hawaii Clinical Research Center
    • Kentucky
      • Florence, Kentucky, United States, 41042
        • Hartford Research Group
    • Michigan
      • Okemos, Michigan, United States, 48864
        • Summit Research Network
    • New Jersey
      • Clementon, New Jersey, United States, 08021
        • CNS Research Institute
    • New York
      • Brooklyn, New York, United States, 11235
        • Social Psychiatry Research Inst.
      • Lawrence, New York, United States, 11559
        • Neurobehavioral Research, Inc.
      • New York, New York, United States, 10024
        • The Medical Research Network
      • New York, New York, United States, 10021
        • Social Psychiatry Research Inst.
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Northcoast Clinical Trials
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Portland, Oregon, United States, 97209
        • Summit Research Network
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Carolina Clinical Research Services
    • Utah
      • Salt Lake City, Utah, United States, 84107-7591
        • Radiant Research, Salt Lake City
    • Virginia
      • Arlington, Virginia, United States, 22201
        • Comprehensive Neuroscience of Northern Virginia
    • Washington
      • Seattle, Washington, United States, 98104
        • Summit Research Network

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 3 months of screening
  • 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 Assignment
  • 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

March 1, 2006

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

  • C6671/3031/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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