Evaluation of the Potential Effects of SSR149415 on the Hypothalamic-pituitary-adrenal Axis in Outpatients With Major Depressive Disorder
Evaluation of the Potential Effects of SSR149415 on the Hypothalamic-pituitary-adrenal Axis in Outpatients With Major Depressive Disorder
Primary Objective:

 - To evaluate the effects of two fixed doses of SSR149415 (250 mg bid and 100 mg bid) on
 hypothalamic-pituitary-adrenal axis function in patients with major depressive disorder.

 Secondary Objectives:

 -  To evaluate the tolerability and safety of SSR149415 in patients with major depressive
 disorder.

 -  To evaluate the efficacy of two fixed doses of SSR149415 compared to placebo in patients
 with major depressive disorder.

 -  To evaluate plasma concentrations of SSR149415.
The study consisted of three segments (A, B and C). Segment A was a 1 to 4-week, drug-free,
 screening and baseline period. Segment B was a 4-week, double-blind period. After the last
 dose of double-blind study medication in Segment B, all patients had to enter Segment C, a
 1-week drug-free, follow-up period.

 The total study duration for one patient participating in all segments of the study was 6
 weeks.
Inclusion criteria :

 -  Diagnosis of major depressive disorder as defined by the Diagnostic and Statistical
 Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) and the Mini
 International Neuropsychiatric Interview (MINI) criteria.

 Exclusion criteria:

 -  Outpatients unwilling to be hospitalized a total of 6 nights and 8 days.

 -  Total score of less than 21 (<21) on the 17-item Hamilton Depression Rating Scale
 (HAM-D) at Visit 1 (Day -7) or Visit 5 (Day -1).

 -  Patients whose current depressive episode is diagnosed with psychotic features,
 catatonic features, seasonal pattern or post-partum onset or is secondary to a general
 medical disorder.

 -  Patients with alcohol dependence or abuse or substance dependence or abuse in the past
 12 months according to the MINI, except nicotine or caffeine dependence.

 -  Patients who have used the following prior to entry into Segment B: any antipsychotic
 within 3 months; fluoxetine within 1 month; any monoamine oxidase inhibitor (MAOI)
 within 2 weeks; any other antidepressant, anxiolytic, sedative-hypnotic, or
 mood-stabilizer (lithium, anticonvulsants) within 7 days except permitted concomitant
 medications

 -  The above information is not intended to contain all considerations relevant to a
 patient's potential participation in a clinical trial.