Clinical trial NCT00214994: Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults With Generalized Anxiety Disorder.
Official title: A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Efficacy of GABITRIL Treatment (up to 16 mg/Day) in Adults With Generalized Anxiety Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety Disorders
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults with Generalized Anxiety Disorder.


Eligibility criteria: Subjects who have completed 10 weeks of double-blind treatment and the subsequent taper period in 1 of the 3 previous double-blind studies (studies C6671/3030/AX/US, C6671/3031/AX/US, or C6671/3032/AX/US).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Research Group
state: Alabama
city: Mesa
country: United States
facility: Pivotal Research Center
state: Arizona
city: Peoria
country: United States
facility: Pivotal Research
state: Arizona
city: Beverly Hills
country: United States
facility: Southwestern Research
state: California
city: El Centro
country: United States
facility: Valley Clinical Research
state: California
city: Irvine
country: United States
facility: Irvine Center for Clinical Res
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Los Angeles
country: United States
facility: Pacific Institue for Medical
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Orange
country: United States
facility: Pacific Clinical Research Medi
state: California
city: Riverside
country: United States
facility: Pharmacology Research Institute
state: California
city: San Diego
country: United States
facility: Affiliated Research Institute
state: California
city: San Diego
country: United States
facility: HealthQuest Clinical Trials
state: California
city: Santa Ana
country: United States
facility: Clinical Innovations Inc.
state: California
city: Denver
country: United States
facility: Radiant Research Denver
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut
state: Connecticut
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Orange City
country: United States
facility: Medicial Research Group of Central Florida
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solution
state: Florida
city: Sarasota
country: United States
facility: Roskamp Institute
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: West Palm Beach
country: United States
facility: Clinical Neuroscience Solution
state: Florida
city: Atlanta
country: United States
facility: Atlanta Institue of Medicaine
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Clinical Research
state: Hawaii
city: Aurora
country: United States
facility: American Medical Research
state: Illinois
city: Edwardsville
country: United States
facility: Cunningham Clinical Research
state: Illinois
city: Northfield
country: United States
facility: Henry Lahmeyer, MD
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Midwest Center for Neurobehavi
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Overland Park
country: United States
facility: Vince and Associates Clinical
state: Kansas
city: Florence
country: United States
facility: Hartford Research Ltd
state: Kentucky
city: Owensboro
country: United States
facility: Pedia Research, LLC
state: Kentucky
city: Paducah
country: United States
facility: Four Rivers Clinical Research
state: Kentucky
city: New Orleans
country: United States
facility: LSUHSC New Orleans
state: Louisiana
city: Shreveport
country: United States
facility: LSUHSC in Shreveport
state: Louisiana
city: Rockville
country: United States
facility: Capital Clinical Research Asso
state: Maryland
city: Rockville
country: United States
facility: Dupont Clinical Research
state: Maryland
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Farmington Hills
country: United States
facility: Summit Research Network Farmin
state: Michigan
city: Okemos
country: United States
facility: Summit Research Network Michig
state: Michigan
city: St. Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Las Vegas
country: United States
facility: Radiant Research Las Vegas
state: Nevada
city: Clementon
country: United States
facility: CNS Research Institute
state: New Jersey
city: Moorestown
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Brooklyn
country: United States
facility: Social Psychiatry Research Ins
state: New York
city: Lawrence
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: New York
country: United States
facility: Eastside Comprehensive Medical
state: New York
city: New York
country: United States
facility: Fieve Clinical Services, Inc.
state: New York
city: New York
country: United States
facility: Medical and Behavioral
state: New York
city: New York
country: United States
facility: Medical Research Network
state: New York
city: Staten Island
country: United States
facility: Behavioral Medical Research
state: New York
city: Morganton
country: United States
facility: Medark Clinical Trials and Research
state: North Carolina
city: Raleigh
country: United States
facility: Richard Weisler, MD and Assoc
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Beechwood
country: United States
facility: North Coast Clinical Trials
state: Ohio
city: Cincinnati
country: United States
facility: Hartford Research Group
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Ctr
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pahl Pharmaceutical Research
state: Oklahoma
city: Eugene
country: United States
facility: OCCI Eugene
state: Oregon
city: Portland
country: United States
facility: Summit Research Network Inc.
state: Oregon
city: Salem
country: United States
facility: OCCI, Inc.
state: Oregon
city: Norristown
country: United States
facility: Keystone Clinical Studies LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: CNS Research Institute PC
state: Pennsylvania
city: Charleston
country: United States
facility: South East Health Consultants
state: South Carolina
city: Columbia
country: United States
facility: Carolina Clinical Research Ser
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solution
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Bellaire
country: United States
facility: Claghorn-Lesem Research
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Fabre Research Clinics, Inc.
state: Texas
city: Lake Jackson
country: United States
facility: R D Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Croft Group Research Center
state: Texas
city: Salt Lake City
country: United States
facility: Radiant Research Salt Lake
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Arlington
country: United States
facility: Comprehensive Neuroscience Of
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research
state: Washington
city: Seattle
country: United States
facility: Summit Seattle Boren
state: Washington
city: Brown Deer
country: United States
facility: Northbrook Research Center
state: Wisconsin
city: Middleton
country: United States
facility: Dean Foundation
state: Wisconsin
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Hamilton
country: Canada
facility: McMaster University Medical Ce
state: Ontario
city: Toronto
country: Canada
facility: Center for Addiction and Mental Health, Mood and Anxiety Program
state: Ontario
city: Toronto
country: Canada
facility: Mood & Anxiety Disorders Ctr
state: Ontario
city: Quebec
country: Canada
facility: Clinique Marie-Fitzbach
Study officials:
References: