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-SE
• Lead Sponsor: Sanofi-Aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-13
• 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