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

Sponsored by:	Cephalon
Information provided by:	Cephalon
ClinicalTrials.gov Identifier:	NCT00236054

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 III

MedlinePlus related topics: Anxiety

Drug Information available for: Tiagabine Tiagabine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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 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

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
Janus Center for Psychiatric Research
West Palm Beach, Florida, United States, 33407
UF Behavioral Health Clinic
Jacksonville, Florida, United States, 32257
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
Medical and Behavioral Health Research, PC
New York, New York, United States, 10023
Eastside Comprehensive Medical Center
New York, New York, United States, 10021
Social Psychiatry Research Inst.
Brooklyn, New York, United States, 11235
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

Study ID Numbers:	C6671/3032/AX/US
Study First Received:	October 7, 2005
Last Updated:	April 12, 2006
ClinicalTrials.gov Identifier:	NCT00236054
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anxiety Disorders
Tiagabine
Mental Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
GABA Agonists

Therapeutic Uses
Physiological Effects of Drugs
GABA Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009