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

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00236054
• Other study ID #: C6671/3032/AX/US
• Status: Completed
• Phase: Phase 3
• First received: October 7, 2005
• Last updated: May 8, 2014
• Start date: October 2004
• Est. completion date: December 2005

Study information

• Verified date: May 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 the past 3 months

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Drug:
• Gabitril

Locations

Country	Name	City	State
United States	Atlanta Institute of Medicine & Research - Atlanta Clinic	Atlanta	Georgia
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Social Psychiatry Research Inst.	Brooklyn	New York
United States	Northbrooke Research	Brown Deer	Wisconsin
United States	South East Health Consultants, LLC	Charleston	South Carolina
United States	Hartford Research Group Ltd.	Cincinnati	Ohio
United States	Cunningham Clinical Research, LLC	Edwardsville	Illinois
United States	Summit Research Network	Farmington Hills	Michigan
United States	UF Behavioral Health Clinic	Jacksonville	Florida
United States	Pacific Institute for Medical Research, Inc.	Los Angeles	California
United States	LSUHSC Anxiety and Mood Disorders Clinic	New Orleans	Louisiana
United States	Eastside Comprehensive Medical Center	New York	New York
United States	Medical and Behavioral Health Research, PC	New York	New York
United States	Pharmacology Research Institute	Newport Beach	California
United States	Oregon Center for Clinical Investigations, Inc.	Salem	Oregon
United States	Affiliated Research Institute	San Diego	California
United States	Health Quest Clinical Trials	San Diego	California
United States	Pacific Clinical Research Medical Group	Upland	California
United States	Janus Center for Psychiatric Research	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessment of proportion of responders and
Secondary	patients in remission according to HAM-A scores and CGI ratings by
Secondary	visit, assessment of the safety and tolerability in patients with GAD