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

Completed · Phase 3

Conditions studied: Generalized Anxiety Disorder

In brief

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).

Key facts

Study ID

NCT00236067

Run by

Cephalon

People needed

440

Starts

2004-10-01

Expected to finish

2006-03-01

Last updated by the study team

2014-05-09

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Birmingham Research Group — Birmingham, Alabama, United States
• Southwestern Research Institute — Beverly Hills, California, United States
• Pharmacology Research Institute — Northridge, California, United States
• Pacific Clinical Research — Orange, California, United States
• Carman Research — Smyrna, Georgia, United States
• Hawaii Clinical Research Center — Honolulu, Hawaii, United States
• Hartford Research Group — Florence, Kentucky, United States
• Summit Research Network — Okemos, Michigan, United States
• CNS Research Institute — Clementon, New Jersey, United States
• Social Psychiatry Research Inst. — Brooklyn, New York, United States
• Neurobehavioral Research, Inc. — Lawrence, New York, United States
• Social Psychiatry Research Inst. — New York, New York, United States
• The Medical Research Network — New York, New York, United States
• Northcoast Clinical Trials — Beachwood, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Summit Research Network — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Carolina Clinical Research Services — Columbia, South Carolina, United States
• Radiant Research, Salt Lake City — Salt Lake City, Utah, United States
• Comprehensive Neuroscience of Northern Virginia — Arlington, Virginia, United States
• Summit Research Network — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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