drugset / Trial / NCT00361491

An Eight-Week Study Evaluating the Efficacy of Two Fixed Doses (250 mg Twice Daily and 100 mg Twice Daily) of SSR149415 in Patients With Major Depressive Disorder

NCT00361491

Phase 2 Completed 324 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to evaluate the efficacy of SSR149415 in the treatment of Major Depressive Disorder, defined as a change from baseline to visit 7 in the Hamilton Depression Rating Scale. To evaluate the tolerability, safety and efficacy on disability and quality of life in patients with major depressive disorder.To evaluate plasma concentrations of SSR149415.

Timeline

Start
2006-08
Primary completion
2007-09
Completion
2007-09

Drugs

EvaluationDrugModalityDoseRoute
Subject NELIVAPTAN Small molecule 100 mg
Subject NELIVAPTAN Small molecule 250 mg

Indications