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

Generalized Anxiety Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00236067
• Other study ID #: C6671/3031/AX/US
• Status: Completed
• Phase: Phase 3
• First received: October 7, 2005
• Last updated: May 8, 2014
• Start date: October 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 Administration
• 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: 440
• 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, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Drug:
• Gabitril

Locations

Country	Name	City	State
United States	Comprehensive Neuroscience of Northern Virginia	Arlington	Virginia
United States	Northcoast Clinical Trials	Beachwood	Ohio
United States	Southwestern Research Institute	Beverly Hills	California
United States	Birmingham Research Group	Birmingham	Alabama
United States	Social Psychiatry Research Inst.	Brooklyn	New York
United States	CNS Research Institute	Clementon	New Jersey
United States	Carolina Clinical Research Services	Columbia	South Carolina
United States	Hartford Research Group	Florence	Kentucky
United States	Hawaii Clinical Research Center	Honolulu	Hawaii
United States	Neurobehavioral Research, Inc.	Lawrence	New York
United States	Social Psychiatry Research Inst.	New York	New York
United States	The Medical Research Network	New York	New York
United States	Pharmacology Research Institute	Northridge	California
United States	Summit Research Network	Okemos	Michigan
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Pacific Clinical Research	Orange	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Summit Research Network	Portland	Oregon
United States	Radiant Research, Salt Lake City	Salt Lake City	Utah
United States	Summit Research Network	Seattle	Washington
United States	Carman Research	Smyrna	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Country where clinical trial is conducted

United States, 

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 endpoint 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