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

• Conditions: Major depression disorders and irritable bowel syndrome.; MedDRA version: 12.0Level: LLTClassification code 10025453Term: Major depressive disorder NOS; MedDRA version: 12.0Level: LLTClassification code 10023003Term: Irritable bowel syndrome

• Registration Number: EUCTR2009-010339-42-FI
• Lead Sponsor: Sanofi-Aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-23
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 580

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

Exclusion Criteria

1. Age less than 18 years (<18) or greater than 64 years (>64)
2. Total score of less than 18 (<18) on the 17-item Hamilton Depression Rating Scale (HAM-D) total score.
3. Total score of less than 24 (<24) on the Montgomery-Asberg Depression Rating Scale (MADRS) total score.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;Secondary Objective: To evaluate the tolerability and safety of SSR125543 in outpatients with major depressive disorder. <br><br>To evaluate plasma concentrations of SSR125543.<br>;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.