The purpose of the study is to evaluate the long-term efficacy and safety of Saredutant in patients with depression. The primary objective is to evaluate the efficacy and safety of Saredutant 100 mg once daily compared to placebo in the prevention of relapse of depressive symptoms in outpatients with major depressive disorder who achieved an initial response to 12 weeks of open-label treatment with Saredutant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
430
oral administration (capsules)
oral administration (capsules)
Sanofi-Aventis
Bridgewater, New Jersey, United States
The time to relapse of depressive symptoms (in days) during the Maintenance Phase.
Time frame: minimum 24 weeks and maximum 52 weeks
Changes from baseline in the CGI Severity of Illness, Montgomery-Asberg Depression Rating Scale (MADRS) total, and Hamilton Anxiety Rating Scale (HAM-A) total and factor scores during the Maintenance Phase.
Time frame: minimum 24 weeks and maximum 52 weeks
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