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

• Gabitril (Drug)

Primary outcomes

• 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 outcomes

• 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

Sex: All, ages: 18 Years to 64 Years

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