Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS)
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To evaluate the efficacy of two fixed doses of SR58611A (175 mg q12 and 350 mg q12) compared to placebo in patients with Major Depressive Disorder (MDD) using paroxetine (20 mg qd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated.
An Eight-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Paroxetine (10 mg qd) as Positive Control, Evaluating the Efficacy, Safety, Tolerability of Two Fixed Doses of SR58611A (175 mg q12/ 350 mg q12) in Outpatients With MDD
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patient with Major Depressive Disorder diagnosed according to Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR
Patient meets criteria for a recurrent Major Depressive Episode (MDE)
Patient meets severity assessments of depression specified by the study
Patient is at immediate risk for suicidal behavior
Patient is with a unstable medical condition
Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
Patient has taken concomitant treatment that may interfere with valid collection or interpretation of study data
Patient has been treated with non-pharmacologic therapy intended to treat depression in the past 6 months
Patient has been treated with paroxetine (Paxil) within the previous 6 months
Patient is pregnant or breastfeeding, or likely to become pregnant during the course of the study