The primary objective of the study is to compare, after 8 weeks, the efficacy of SR58611A vs. placebo in patients with Major Depressive Disorder who are on concomitant treatment with escitalopram. The secondary objective of this study is to document clinical safety and tolerability of SR58611A in association with escitalopram.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
510
Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi-Aventis Administrative Office
Tatari, Estonia
Sanofi-Aventis Administrative Office
Helsinki, Finland
Change from baseline in Hamilton Depression Rating scale (HAM-D) total score
Time frame: 8 weeks
Speed of response based on HAM-D and change in Clinical Global Impression (CGI) severity score
Time frame: 8 weeks
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Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Athens, Greece
Sanofi-Aventis Administrative Office
Mumbai, India
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Sanofi-Aventis Administrative Office
Casablanca, Morocco
Sanofi-Aventis Administrative Office
Seoul, South Korea
...and 3 more locations