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

Completed · Phase 3

Conditions studied: 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

NCT00236015

Run by

Cephalon

People needed

880

Starts

2004-11-01

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

• Pivotal Research Center — Peoria, Arizona, United States
• Valley Clinical Research — El Centro, California, United States
• Radiant Research Irvine — Irvine, California, United States
• Pharmacology Research Institute — Los Alamitos, California, United States
• Pharmacology Research Institute — Riverside, California, United States
• Clinical Innovations, Inc. — Santa Ana, California, United States
• Radiant Research — Denver, Colorado, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• Miami Research Associates — Miami, Florida, United States
• Medical Research Group of Central Florida — Orange City, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Roskamp Institute, Clinical Trials Division — Sarasota, Florida, United States
• Stedman Clinical Trials — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• American Medical Research — Aurora, Illinois, United States
• Henry Lahmeyer MD & Associates — Northfield, Illinois, United States
• Midwest Center for Neurobehavioral Medicine — Oakbrook Terrace, Illinois, United States
• Indiana University Hospital AOC — Indianapolis, Indiana, United States
• Vince & Associates Clinical Research — Overland Park, Kansas, United States
• Pedia Research, LLC — Owensboro, Kentucky, United States
• Four Rivers Clinical Research — Paducah, Kentucky, United States
• LSU Health Science Center — Shreveport, Louisiana, United States
• Capital Clinical Research Associates — Rockville, Maryland, United States
• Dupont Clinical Research — Rockville, Maryland, United States
• Pivotol Research Centers — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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