drugset / Trial / NCT00629551

An Eight-week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive Disorder

NCT00629551

Phase 3 Completed 825 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The main purpose of this study is to evaluate the efficacy of saredutant 100mg or 30mg once daily in combination with paroxetine 20mg once daily compared to saredutant placebo in combination with paroxetine 20mg once daily in patients with major depressive disorder. The study also includes a double-placebo group (saredutant placebo in combination with paroxetine placebo).

Timeline

Start
2008-02
Primary completion
2009-02
Completion
2009-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Saredutant Small molecule 30 mg Oral
Subject Saredutant Small molecule 100 mg Oral
Background Paroxetine Small molecule 20 mg Oral