A 10-Week Study for Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
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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
Study Start Date :
Study Completion Date :
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Ages Eligible for Study:
18 Years to 64 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
• 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).
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