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A 10-Week Efficacy and Safety Study for 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:
NCT00236054
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
Endpoint Classification: Safety/Efficacy Study
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: December 2005
  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 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
  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: NCT00236054

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

No publications provided

ClinicalTrials.gov Identifier: NCT00236054     History of Changes
Other Study ID Numbers: C6671/3032/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 November 24, 2014