Primary objective : * To demonstrate the antidepressant efficacy on the Hamilton Depression Rating Scale of SR58611A 700mg/day compared with placebo in the treatment of patients with a recurrent major depressive episode. Secondary objectives: * To assess the safety profile of SR58611A 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
317
oral administration 2 X 350mg/day at 12 hours intervals
oral administration 12 hours intervals
oral 20 mg/day
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Sanofi-Aventis Administrative Office
Zagreb, Croatia
Sanofi-Aventis Administrative Office
Prague, Czechia
Sanofi-Aventis Administrative Office
Tallinn, Estonia
change from baseline of the total score of the HAM-D 17 items.
Time frame: 6 weeks
HAM-D subscores
Time frame: 6 weeks
HAM-D responders and remitters
Time frame: 6 weeks
HAM-A total score and subscores
Time frame: 6 weeks
MADRS total score
Time frame: 6 weeks
clinical global impression (CGI) severity and improvement scores
Time frame: 6 weeks
patient global impression (PGI) improvement score
Time frame: 6 weeks
social and occupational functioning assessment scale (SOFAS) score
Time frame: 6 weeks
clinical monitoring of adverse events (AEs)
Time frame: 6 weeks
laboratory parameters
Time frame: 6 weeks
electrocardiogram (ECG) parameters, change in vital signs and body weight
Time frame: 6 weeks
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Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Montenegro, Montenegro
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Sanofi-Aventis Administrative Office
Belgrade, Serbia