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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00236067
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : May 9, 2014
Information provided by:
Teva Pharmaceutical Industries

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Drug: Gabitril Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2004
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Primary Outcome Measures :
  1. 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 :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00236067

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Sponsors and Collaborators
Cephalon Identifier: NCT00236067     History of Changes
Other Study ID Numbers: C6671/3031/AX/US
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Anxiety Disorders
Pathologic Processes
Mental Disorders
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
GABA Agonists
GABA Agents