Clinical trial NCT00236054: A 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Generalized Anxiety Disorder
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: 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 outcomes:
measure: Assessment of proportion of responders and
measure: patients in remission according to HAM-A scores and CGI ratings by
measure: visit, assessment of the safety and tolerability in patients with GAD
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pacific Institute for Medical Research, Inc.
state: California
city: Newport Beach
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: Health Quest Clinical Trials
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Jacksonville
country: United States
facility: UF Behavioral Health Clinic
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center for Psychiatric Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Institute of Medicine & Research - Atlanta Clinic
state: Georgia
city: Edwardsville
country: United States
facility: Cunningham Clinical Research, LLC
state: Illinois
city: New Orleans
country: United States
facility: LSUHSC Anxiety and Mood Disorders Clinic
state: Louisiana
city: Farmington Hills
country: United States
facility: Summit Research Network
state: Michigan
city: Brooklyn
country: United States
facility: Social Psychiatry Research Inst.
state: New York
city: New York
country: United States
facility: Eastside Comprehensive Medical Center
state: New York
city: New York
country: United States
facility: Medical and Behavioral Health Research, PC
state: New York
city: Cincinnati
country: United States
facility: Hartford Research Group Ltd.
state: Ohio
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations, Inc.
state: Oregon
city: Charleston
country: United States
facility: South East Health Consultants, LLC
state: South Carolina
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Brown Deer
country: United States
facility: Northbrooke Research
state: Wisconsin
Study officials:
References: