A Trial Evaluating the Efficacy and Tolerability of SSR125543 in Outpatients With Major Depressive Disorder

Phase 2

Completed

• Conditions: Major Depression
• Interventions: Drug: SSR125543; Drug: escitalopram; Drug: placebo

• Registration Number: NCT01034995
• Lead Sponsor: Sanofi

Brief Summary

Primary 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 Objectives:

* To evaluate the tolerability and safety of SSR125543 in outpatients with major depressive disorder

* To evaluate plasma concentrations of SSR125543

Detailed Description

This duration of this trial is 11 weeks.

Study Timeline

• Study First Submitted: 2009-12-17
• Study First Submitted QC: 2009-12-17
• Study First Posted: 2009-12-18
• Study Start: 2010-02
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-13
• Last Update Posted: 2011-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 580

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SSR125543 20 mg	SSR125543	1 capsule of SSR125543 20 mg + 1 capsule of placebo
escitalopram 10 mg	escitalopram	1 capsule of escitalopram 10 mg + 1 capsule of placebo
placebo	placebo	2 capsules of placebo
SSR125543 50 mg	SSR125543	1 capsule of SSR125543 50 mg + 1 capsule of placebo
SSR125543 100 mg	SSR125543	2 capsules of SSR125543 50 mg

Primary Outcome Measures

Name	Time	Method
Change from baseline (Day -1) to Day 56 in the 17-item HAM-D total score	8 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in HAM-D depressed mood item	8 weeks
Change from baseline in HAM-D responders (50% improvement)	8 weeks
Changes from baseline in the HAM-D core and factor scores	8 weeks
Changes from baseline in the Montgomery-Asberg depression rating scale (MADRS) total score	8 weeks
Changes from baseline in the Clinical Global Impression (CGI) Severity of Illness score	8 weeks

Trial Locations

Locations (73)

Sanofi-Aventis Investigational Site Number 056002; 🇧🇪 Asse, Belgium

Sanofi-Aventis Investigational Site Number 056003; 🇧🇪 Bruxelles, Belgium

Sanofi-Aventis Investigational Site Number 056001; 🇧🇪 Liège, Belgium

Sanofi-Aventis Investigational Site Number 124011; 🇨🇦 Burlington, Canada

Sanofi-Aventis Investigational Site Number 124012; 🇨🇦 Chatham, Canada

Sanofi-Aventis Investigational Site Number 124004; 🇨🇦 Edmonton, Canada

Sanofi-Aventis Investigational Site Number 124003; 🇨🇦 Gatineau, Canada

Sanofi-Aventis Investigational Site Number 124001; 🇨🇦 Kelowna, Canada

Sanofi-Aventis Investigational Site Number 124006; 🇨🇦 Mississauga, Canada

Sanofi-Aventis Investigational Site Number 124008; 🇨🇦 Penticton, Canada

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