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

Anxiety Disorder Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00236015
• Other study ID #: C6671/3030/AX/US
• Status: Completed
• Phase: Phase 3
• First received: October 7, 2005
• Last updated: May 8, 2014
• Start date: November 2004
• Est. completion date: March 2006

Study information

• Verified date: May 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• 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: 880
• Est. completion date: March 2006
• 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 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders

Intervention

Drug:
• Gabitril

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	Mood Disorders Clinic	Hamilton	Ontario
Canada	Clinique Marie-Fitzbach,	Quebec
Canada	Center for Addiction and Mental Health, Mood and Anxiety Program	Toronto	Ontario
Canada	University of British Columbia, Vancouver	Vancouver	British Columbia
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
United States	Emory University	Atlanta	Georgia
United States	American Medical Research	Aurora	Illinois
United States	Future Search Trials	Austin	Texas
United States	Claghorn-Lesem Research Clinic, Inc.	Bellaire	Texas
United States	Mood Disorders Research Clinic; UT Southwestern Medical Center at Dallas	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Radiant Research	Denver	Colorado
United States	Wayne State University	Detroit	Michigan
United States	Valley Clinical Research	El Centro	California
United States	Oregon Center for Clinical Investigations, Inc.	Eugene	Oregon
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Indiana University Hospital AOC	Indianapolis	Indiana
United States	Radiant Research Irvine	Irvine	California
United States	R/D Clinical Research, Inc.	Lake Jackson	Texas
United States	Radiant Research	Las Vegas	Nevada
United States	Pharmacology Research Institute	Los Alamitos	California
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	Pivotol Research Centers	Mesa	Arizona
United States	Miami Research Associates	Miami	Florida
United States	Dean Foundation	Middleton	Wisconsin
United States	Center for Emotional Fitness	Moorestown	New Jersey
United States	Medark Clinical Trials and Research	Morganton	North Carolina
United States	Fieve Clinical Services, Inc.	New York	New York
United States	Keystone Clinical Studies, LLC	Norristown	Pennsylvania
United States	Henry Lahmeyer MD & Associates	Northfield	Illinois
United States	Midwest Center for Neurobehavioral Medicine	Oakbrook Terrace	Illinois
United States	Pahl Pharmaceutical Research, LLC	Oklahoma City	Oklahoma
United States	Medical Research Group of Central Florida	Orange City	Florida
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Vince & Associates Clinical Research	Overland Park	Kansas
United States	Pedia Research, LLC	Owensboro	Kentucky
United States	Four Rivers Clinical Research	Paducah	Kentucky
United States	Pivotal Research Center	Peoria	Arizona
United States	CNS Research Institute	Philadelphia	Pennsylvania
United States	Richard Weisler, MD and Associates	Raleigh	North Carolina
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Pharmacology Research Institute	Riverside	California
United States	Capital Clinical Research Associates	Rockville	Maryland
United States	Dupont Clinical Research	Rockville	Maryland
United States	University of Utah Mood Disorders Clinic	Salt Lake City	Utah
United States	Croft Group Research Center	San Antonio	Texas
United States	Clinical Innovations, Inc.	Santa Ana	California
United States	Roskamp Institute, Clinical Trials Division	Sarasota	Florida
United States	LSU Health Science Center	Shreveport	Louisiana
United States	Regions Hospital - Department of Behavioral Health	St. Paul	Minnesota
United States	Behavioral Medical Research of Staten Island	Staten Island	New York
United States	Stedman Clinical Trials	Tampa	Florida
United States	Center for Psychopharmacologic Research and Treatment	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Countries where clinical trial is conducted

United States,  Canada, 

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 end point in the total score of the HAM-A scale.
Secondary	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