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

Phase 3

Completed

• Conditions: Generalized Anxiety Disorder

• Registration Number: NCT00236067
• Lead Sponsor: Cephalon

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-10-07
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-12
• Study Completion: 2006-03
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-08
• Last Update Posted: 2014-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction of symptomatology associated with Generalized Anxiety Disorder as assessed by the change from baseline to endpoint in the total score of the HAM-A scale.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (18)

Birmingham Research Group; 🇺🇸 Birmingham, Alabama, United States

Southwestern Research Institute; 🇺🇸 Beverly Hills, California, United States

Pharmacology Research Institute; 🇺🇸 Northridge, California, United States

Pacific Clinical Research; 🇺🇸 Orange, California, United States

Carman Research; 🇺🇸 Smyrna, Georgia, United States

Hawaii Clinical Research Center; 🇺🇸 Honolulu, Hawaii, United States

Hartford Research Group; 🇺🇸 Florence, Kentucky, United States

Summit Research Network; 🇺🇸 Seattle, Washington, United States

CNS Research Institute; 🇺🇸 Clementon, New Jersey, United States

Social Psychiatry Research Inst.; 🇺🇸 New York, New York, United States

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