Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (PHOENIX)

Inclusion Criteria:

Main inclusion criteria:

• 1. Out-patients, 18 year and older.
• 2. Major Depressive Disorder (MDD) with a recurrentMajor Depressive Episode (MDE) according to DSMIV-TR criteria
• 3. Duration of current episode is at least of 6 weeksunless severity of symptoms justifies shorter duration.
• 4. Patients have been treated or hospitalized for aprevious episode, or a previous episode requiredantidepressant treatment(s) at the recommended doselevel for a continuous total duration of at least 2months.

Exclusion Criteria:

Main exclusion criteria:

• 1. Patients at immediate risk for suicidal behavior
• 2. Patients with a MDE with psychotic features, catatonic features, seasonal pattern or postpartum onset
• 3. The duration of the current depressive episode is greater than 2 years
• 4. Patients whose current depressive episode is secondary to a general medical condition
• 5. Patients with a lifetime history of (1) bipolar disorder, (2) psychotic disorder, (3) antisocial personality disorder
• 6. Patients who have received non-pharmacologic, somatic treatments for psychiatric disease
• 7. Patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening