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

Cephalon

Status and phase: Completed; Phase 3

Conditions: Anxiety Disorder

Treatments: Drug: Gabitril

Study type: Interventional

Funder types: Industry

Identifiers

NCT00236015

C6671/3030/AX/US

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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