A 10-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Gabitril at 4, 8, and 12 mg/Day in the Treatment of Adults With Generalized Anxiety Disorder.

Cephalon51 sites in 2 countries880 target enrollmentNovember 2004

ConditionsAnxiety Disorder

DrugsGabitril

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Anxiety Disorder
Sponsor: Cephalon
Enrollment: 880
Locations: 51
Primary Endpoint: 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.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

November 2004

End Date

March 2006

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cephalon

Eligibility Criteria

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

Outcomes

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