The purpose of the study is to evaluate the efficacy of saredutant in the treatment of Major Depressive Disorder in elderly patients.To evaluate the tolerability, safety and efficacy on disability and quality of life in patients with major depressive disorder.To evaluate safety and tolerability of 24 weeks of additional treatment in patients completing the initial 8-week treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
393
oral administration (capsules)
oral administration (capsules)
oral administration (capsules)
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Zagreb, Croatia
Sanofi-Aventis Administrative Office
Prague, Czechia
Sanofi-Aventis Administrative Office
Paris, France
Change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.
Time frame: Day 56
Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score.
Time frame: Day 56
Change from baseline to Day 56 in the HAM-D depressed mood item score
Time frame: Day 56
Change from baseline to Day 56 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
Time frame: Day 56
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Sanofi-Aventis Administrative Office
México, Mexico
Sanofi-Aventis Administrative Office
Moscow, Russia
Sanofi-Aventis Administrative Office
Bromma, Sweden
Sanofi-Aventis Administrative Office
Istanbul, Turkey (Türkiye)