A 10-Week Efficacy and Safety Study for 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

NCT00236054

Run by

Cephalon

People needed

440

Starts

2004-10-01

Expected to finish

2005-12-01

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 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

Where it is running

• Pacific Institute for Medical Research, Inc. — Los Angeles, California, United States
• Pharmacology Research Institute — Newport Beach, California, United States
• Affiliated Research Institute — San Diego, California, United States
• Health Quest Clinical Trials — San Diego, California, United States
• Pacific Clinical Research Medical Group — Upland, California, United States
• UF Behavioral Health Clinic — Jacksonville, Florida, United States
• Janus Center for Psychiatric Research — West Palm Beach, Florida, United States
• Atlanta Institute of Medicine & Research - Atlanta Clinic — Atlanta, Georgia, United States
• Cunningham Clinical Research, LLC — Edwardsville, Illinois, United States
• LSUHSC Anxiety and Mood Disorders Clinic — New Orleans, Louisiana, United States
• Summit Research Network — Farmington Hills, Michigan, United States
• Social Psychiatry Research Inst. — Brooklyn, New York, United States
• Eastside Comprehensive Medical Center — New York, New York, United States
• Medical and Behavioral Health Research, PC — New York, New York, United States
• Hartford Research Group Ltd. — Cincinnati, Ohio, United States
• Oregon Center for Clinical Investigations, Inc. — Salem, Oregon, United States
• South East Health Consultants, LLC — Charleston, South Carolina, United States
• Northwest Clinical Research Center — Bellevue, Washington, United States
• Northbrooke Research — Brown Deer, Wisconsin, United States

Full record on ClinicalTrials.gov

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