An Eight-Week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression

Exclusion Criteria

• •1.Patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum onset.
• •2.The duration of the current depressive episode is greater than 2 years.
• •3.Patients who are currently suicidal or have a history of a suicide attempt within 3 years prior to entry.
• •4.Patients whose current depressive episode is secondary to a general medical disorder.
• •5.Patients with a history or presence of bipolar disorders or psychotic disorders according to the D and L criteria of the MINI.
• •6.Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
• •7.Patients with a history of failure to respond to treatment with paroxetine or other antidepressant medications.
• •8.Patients who have used the following prior to entry into Segment B: any antipsychotic within 3 months,-fluoxetine within 35 days, -any monoamine oxidase inhibitor within 21 days, any other antidepressant, anxiolytic, sedative-hypnotic, or mood-stabilizer (lithium, anticonvulsants) within 7 days except permitted concomitant medications.
• •9.Females who are pregnant or breast-feeding.
• •10\. evere or unstable cardiovascular, renal, hepatic, respiratory, hematological, endocrinological, neurological, or other somatic disease that might interfere with the evaluation of study medication.
• •11.History of seizures other than a single childhood febrile seizure.
• •12.ECG abnormalities of potential clinical significance including a QT interval with Bazett's correction of 500 msec or more at entry.
• •13.Use of known inducers or potent inhibitors of CYP3A4 within 7 days of entry.
• •14.Use of drugs with known risk for Torsade de Pointes within 7 days of entry into Segment B.
• •15.Participation in a clinical trial of an experimental therapy within 30 days prior to entry or prior participation in a clinical trial of saredutant.
• •16.Patients with a positive HbsAg or anti-HCV antibody test at screening.
• •17.Patients with any of the following at screening: ALT \>2 times the upper limit of the normal range (XULN), AST \>2XULN, GGT \>3XULN, total or conjugated bilirubin \>ULN