Clinical trial NCT00236015: A 10-Week Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety Disorder
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 880
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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).


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

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