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

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

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).

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