Clinical trial NCT00256113 (phase 3, status: completed)
Conditions: depressive disorder
ICD codes: F25.1, F33.0, F33.1, F33.9, F32.0, F32.1, F32.9
Drugs: saredutant succinate (sr48968c)
SMILES: CN(C[C@@H](CCN1CCC(CC1)(NC(C)=O)C1=CC=CC=C1)C1=CC=C(Cl)C(Cl)=C1)C(=O)C1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  1. Male or female patients.

          -  2. 18 to 64 years of age.

          -  3. Inpatients or outpatients.

          -  4. Written informed consent from the patient and/or legally authorized representative.

          -  5. Able to comply with the protocol and follow written and verbal instructions.

          -  6. Subjects of childbearing potential must have a confirmed negative serum b-hCG test
             prior to entry into Segment B and must employ an acceptable method of birth control
             (e.g., oral, depot, or implanted contraceptive method, IUDs, sterilization, barrier
             methods in conjunction with spermicide).

          -  7. Diagnosis of major depressive disorder, as defined by Diagnostic and Statistical
             Manual of Mental Disorders, 4th edition, Text Revision criteria and confirmed by the
             semi-structured Mini International Neuropsychiatric Interview (MINI), recurrent
             episode for at least one month prior to the entry.

          -  8. Minimum total score of 22 on the Montgomery-Asberg Depression Rating Scale (MADRS).

        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. Severe 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