An 8 Week Study Of Adults Diagnosed With Major Depressive Disorder
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A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Flexible-Dose Study Evaluating Efficacy, Safety, and Tolerability of Once-Daily Oral GW353162 (40-60mg) Versus Placebo in Subjects With Major Depressive Disorder Over an Eight-Week Treatment Period.
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
Resource links provided by the National Library of Medicine
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score after 8 weeks of treatment [ Time Frame: 8 Weeks ]
Secondary Outcome Measures :
Change in the MADRS score at other timepoints; change in the Global Impression; percentage of remitters and responders based on the MADRS; change in anxiety, disability, motivation, energy, fatigue and pain; incidence of adverse events during the study
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Ages Eligible for Study:
18 Years to 64 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosis of Major Depressive Disorder (MDD)
Duration of current depressive episode 12 weeks - 24 months
Patients can read and write at a level sufficient to provide a signed consent
If female, patients must be practicing an acceptable method of birth control
Patients have other psychiatric disorders that would affect patient's response to treatment
Patients have not responded to two or more adequate courses of antidepressant therapy
Patients cannot be currently abusing illicit drugs or alcohol
Patients are not currently receiving psychotherapy
Patients have received electroconvulsive therapy within 6 months prior to screening