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

Sponsored by:	Cephalon
Information provided by:	Cephalon
ClinicalTrials.gov Identifier:	NCT00236015

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 III

MedlinePlus related topics: Anxiety

Drug Information available for: Tiagabine Tiagabine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
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.

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

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

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