The purpose of the study is to evaluate the efficacy and safety of SR58611A in elderly patients with depression.The primary objective is to evaluate the efficacy of a 700 mg dose of SR58611A compared to placebo in elderly patients with depression. The secondary objectives are to evaluate the safety of SR58611A and to evaluate the efficacy of SR58611A on disability and quality of life in elderly patients with depression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
288
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Sanofi-Aventis Administrative Office
Helsinki, Finland
Sanofi-Aventis Administrative Office
Bucharest, Romania
Sanofi-Aventis Administrative Office
Belgrade, Serbia
The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Depression Rating Scale (HAM-D) total score.
The main secondary outcomes are the changes from baseline to Day 56 of treatment in the HAM-D depressed mood item, the Montgomery Asberg Depression Rating Scale total, and the Clinical Global Impression Severity of Illness scores.
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Sanofi-Aventis Administrative Office
Bratislava, Slovakia