Status:
COMPLETED
A 10-Week Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
Lead Sponsor:
Cephalon
Conditions:
Anxiety Disorder
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
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
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
880 Patients enrolled
Trial Details
Trial ID
NCT00236015
Start Date
November 1 2004
End Date
March 1 2006
Last Update
May 9 2014
Active Locations (54)
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1
Pivotol Research Centers
Mesa, Arizona, United States, 85210
2
Pivotal Research Center
Peoria, Arizona, United States, 85381
3
Valley Clinical Research
El Centro, California, United States, 92243
4
Radiant Research Irvine
Irvine, California, United States, 92618