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

This study has been completed.
Sponsor:
Information provided by:
Cephalon
ClinicalTrials.gov Identifier:
NCT00236015
First received: October 7, 2005
Last updated: May 26, 2006
Last verified: May 2006
History of Changes
  Purpose

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 Intervention Phase
Anxiety Disorder
 Drug: Gabitril
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: A 10-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Gabitril at 4, 8, and 12 Mg/Day in the Treatment of Adults With Generalized Anxiety Disorder.

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Cephalon:

Primary Outcome Measures:
  • Reduction of symptomatology associated with Generalized Anxiety Disorder as assessed by the change from baseline to end point in the total score of the HAM-A scale.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 880
Study Start Date: November 2004
Estimated Study Completion Date: March 2006
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00236015

  Show 54 Study Locations
Sponsors and Collaborators
Cephalon
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00236015     History of Changes
Other Study ID Numbers: C6671/3030/AX/US
Study First Received: October 7, 2005
Last Updated: May 26, 2006
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Tiagabine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
 Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
GABA Agonists
GABA Agents

ClinicalTrials.gov processed this record on May 23, 2013