Clinical trial NCT00236067: A 10-Week Study for 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, 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 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 endpoint 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: Birmingham
country: United States
facility: Birmingham Research Group
state: Alabama
city: Beverly Hills
country: United States
facility: Southwestern Research Institute
state: California
city: Northridge
country: United States
facility: Pharmacology Research Institute
state: California
city: Orange
country: United States
facility: Pacific Clinical Research
state: California
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Clinical Research Center
state: Hawaii
city: Florence
country: United States
facility: Hartford Research Group
state: Kentucky
city: Okemos
country: United States
facility: Summit Research Network
state: Michigan
city: Clementon
country: United States
facility: CNS Research Institute
state: New Jersey
city: Brooklyn
country: United States
facility: Social Psychiatry Research Inst.
state: New York
city: Lawrence
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: New York
country: United States
facility: Social Psychiatry Research Inst.
state: New York
city: New York
country: United States
facility: The Medical Research Network
state: New York
city: Beachwood
country: United States
facility: Northcoast Clinical Trials
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Columbia
country: United States
facility: Carolina Clinical Research Services
state: South Carolina
city: Salt Lake City
country: United States
facility: Radiant Research, Salt Lake City
state: Utah
city: Arlington
country: United States
facility: Comprehensive Neuroscience of Northern Virginia
state: Virginia
city: Seattle
country: United States
facility: Summit Research Network
state: Washington
Study officials:
References: