Status:
COMPLETED
A 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
Lead Sponsor:
Cephalon
Conditions:
Generalized 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 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT00236054
Start Date
October 1 2004
End Date
December 1 2005
Last Update
May 9 2014
Active Locations (19)
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1
Pacific Institute for Medical Research, Inc.
Los Angeles, California, United States, 90024
2
Pharmacology Research Institute
Newport Beach, California, United States, 92660
3
Affiliated Research Institute
San Diego, California, United States, 92108
4
Health Quest Clinical Trials
San Diego, California, United States, 92123