Efficacy and Safety of One Single Dose of SR58611 Compared to Placebo and Paroxetine

A Double-Blind, Multicenter Study Evaluating the Efficacy and Safety of One Fixed Dose of SR58611A (700 mg/Day) Versus Placebo and Paroxetine (20 mg/Day) in Patients With a Recurrent Major Depressive Episode.

Primary objective is to demonstrate the antidepressant efficacy on the Hamilton depression rating scale (HAM-D) of amibegron (SR58611) 700 mg/day compared to placebo in the treatment of patients with a recurrent major depressive episode (MDD).

Secondary objective is to assess the safety profile of amibegron 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.

Inclusion Criteria:

• patients suffering from a recurrent major depressive episode of at least moderate intensity (DSM-IV)
• patients have been hospitalized for the treatment of a previous episode, or a previous episode required antidepressant treatment(s)at the recommended dose level for at least 2 months.
• the duration of the current episode is of at least six weeks unless the severity of symptoms justifies shorter duration.