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Sponsored by: |
Cephalon |
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Information provided by: | Cephalon |
ClinicalTrials.gov Identifier: | NCT00236067 |
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).
Condition | Intervention | Phase |
---|---|---|
Generalized Anxiety Disorder |
Drug: Gabitril |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
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 |
Estimated Enrollment: | 440 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | March 2006 |
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Study ID Numbers: | C6671/3031/AX/US |
Study First Received: | October 7, 2005 |
Last Updated: | April 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00236067 |
Health Authority: | United States: Food and Drug Administration |
Anxiety Disorders Tiagabine Mental Disorders |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action GABA Agonists |
Therapeutic Uses Physiological Effects of Drugs GABA Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |