drugset / Trial / NCT00345098

A Study of SR58611A in the Prevention of Depression Relapse in Patients With Major Depressive Disorder

NCT00345098

Phase 3 Completed 704 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to assess whether treatment with SR58611A can prevent relapse of depressive symptoms in patients with major depressive disorder. Relapse will be assessed using the MADRS scale.Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with SR58611A are randomized to continue SR58611A or switch to placebo under double blind conditions for up to 52 weeks of additional treatment. The secondary objective is to evaluate the safety of SR58611A in patients with MDD.

Timeline

Start
2006-05
Primary completion
2008-02
Completion
2008-02

Drugs

EvaluationDrugModalityDoseRoute
Subject amibegron Small molecule 350 mg