An eight-week, multinational, multicenter, double-blind, active- and placebo-controlled clinical trial evaluating the efficacy and tolerability of three fixed doses of SSR125543 (20 mg daily, 50 mg daily and 100 mg daily) in outpatients with major depressive disorder. - AGATE

INTERVENTION: Product Code: SSR125543 Pharmaceutical Form: Capsule, hard Current Sponsor code: SSR125543 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Code: SSR125543 Pharmaceutical Form: Capsule, hard Current Sponsor code: SSR125543 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Cipralex Product Name: escitalopram Pharmaceutical Form: Capsule, hard INN or Proposed INN: escitalopram Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: Major depression disorders and irritable bowel syndrome. ; MedDRA version: 12.0 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS ; MedDRA version: 12.0 Level: LLT Classification code 10023003 Term: Irritable bowel syndrome PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of three fixed doses of SSR125543 (20 mg daily, 50 mg daily and 100 mg daily) compared to placebo in outpatients with major depressive disorder, as assessed by the change from baseline (Day ‐1) to Day 56 in the 17‐item Hamilton Depression Rating Scale (HAM‐D) total score. Primary end point(s): The primary efficacy endpoint is the change from baseline (Day ‐1) to Day 56 in the 17‐item HAM‐D total score. Secondary Objective: To evaluate the tolerability and safety of SSR125543 in outpatients with major depressive disorder. ; ; To evaluate plasma concentrations of SSR125543.; INCLUSION CRITERIA: 1. Diagnosis of major depressive disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM‐IV‐TR) criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) criteria. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range