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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00236067
First received: October 7, 2005
Last updated: May 8, 2014
Last verified: May 2014
  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
Generalized Anxiety Disorder
Drug: Gabitril
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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:
  • 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: 440
Study Start Date: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236067

  Show 21 Study Locations
Sponsors and Collaborators
Cephalon
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00236067     History of Changes
Other Study ID Numbers: C6671/3031/AX/US
Study First Received: October 7, 2005
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014