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

Cephalon

Status and phase

Completed

Phase 3

Conditions

Generalized Anxiety Disorder

Treatments

Drug: Gabitril

Study type

Interventional

Funder types

Industry

Identifiers

NCT00236067

C6671/3031/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