Depressive Disorder Clinical Trial
Official title:
An Eight-Week, Multicenter, Double-blind, Placebo-controlled Study Evaluating the Efficacy, Safety, and Tolerability of One Fixed 100 mg Dose of Saredutant in Patients With Major Depressive Disorder
The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C)
in patients with depression.
The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to
placebo in patients with depression.
The secondary objectives are to evaluate the safety of saredutant, to evaluate the efficacy
of saredutant on disability and quality of life in patients with depression, and to evaluate
blood levels of saredutant.
The study is a multicenter, multicountry, randomized, parallel-group, double blind, placebo and paroxetine-controlled study consisting of three segments (A, B, and C). Segment A is a 1-week, placebo, single-blind period and Segment B is an 8-week, double blind period. Patients completing Segment B may be eligible for enrollment into Segment C, a 44-week, double blind extension. All randomized patients must complete a post-study visit 1 week after intake of the last dose of study medication. ;
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