Long Term Safety and Tolerability of SR58611 in Patients With Major Depressive Disorder
Long Term Safety and Tolerability of SR58611 in Patients With Major Depressive Disorder
Primary objective:

 - To evaluate the long-term safety and tolerability of SR58611A (amibegron) patients with
 major depressive disorder (MDD).

 Secondary objective:

 - To determine plasma concentrations of SR58878 (the active metabolite of SR58611A), for
 pharmacokinetic population analyses, to evaluate the quality of life (QoL) in patients with
 MDD, and to evaluate the efficacy of amibegron in patients with MDD.
Inclusion Criteria:

 -  patients as defined by Diagnosis and Statistical Manual of Mental Disorders, recurrent
 episode for at least 1 month prior to entry into the study, and with a total score of
 > 18 on the Hamilton Depression Rating Scale (HAM-D) 17-items.