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 233003; 🇪🇪 Tartu, Estonia

Sanofi-Aventis Investigational Site Number 152007; 🇨🇱 Valparaiso, Chile

Sanofi-Aventis Investigational Site Number 246005; 🇫🇮 Järvenpää, Finland

Sanofi-Aventis Investigational Site Number 246002; 🇫🇮 Tampere, Finland

Sanofi-Aventis Investigational Site Number 703104; 🇸🇰 Michalovce, Slovakia

Sanofi-Aventis Investigational Site Number 703105; 🇸🇰 Rimavska Sobota, Slovakia

Sanofi-Aventis Investigational Site Number 703101; 🇸🇰 Bratislava 2, Slovakia

Sanofi-Aventis Investigational Site Number 703102; 🇸🇰 Bratislava, Slovakia

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

Sanofi-Aventis Investigational Site Number 528001; 🇳🇱 Den Haag, Netherlands

Sanofi-Aventis Investigational Site Number 250006; 🇫🇷 Elancourt, France

Sanofi-Aventis Investigational Site Number 250005; 🇫🇷 Nimes Cedex 9, France

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

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

Sanofi-Aventis Investigational Site Number 250007; 🇫🇷 Dole, France

Sanofi-Aventis Investigational Site Number 643003; 🇷🇺 St-Petersburg, Russian Federation

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

Sanofi-Aventis Investigational Site Number 276008; 🇩🇪 Achim, Germany

Sanofi-Aventis Investigational Site Number 276004; 🇩🇪 Dresden, Germany

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

Sanofi-Aventis Investigational Site Number 124007; 🇨🇦 Sherbrooke, Canada

Sanofi-Aventis Investigational Site Number 250008; 🇫🇷 Arcachon, France

Sanofi-Aventis Investigational Site Number 752001; 🇸🇪 Uppsala, Sweden

Sanofi-Aventis Investigational Site Number 643009; 🇷🇺 St-Petersburg, Russian Federation

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

Sanofi-Aventis Investigational Site Number 124009; 🇨🇦 Toronto, Canada

Sanofi-Aventis Investigational Site Number 250001; 🇫🇷 Grenoble, France

Sanofi-Aventis Investigational Site Number 152002; 🇨🇱 Santiago, Chile

Sanofi-Aventis Investigational Site Number 250004; 🇫🇷 Orvault, France

Sanofi-Aventis Investigational Site Number 703103; 🇸🇰 Roznava, Slovakia

Sanofi-Aventis Investigational Site Number 276003; 🇩🇪 Würzburg, Germany

Sanofi-Aventis Investigational Site Number 643008; 🇷🇺 Rostov-Na-Donu, Russian Federation

Sanofi-Aventis Investigational Site Number 710001; 🇿🇦 Cape Town, South Africa

Sanofi-Aventis Investigational Site Number 710002; 🇿🇦 Durban, South Africa

Sanofi-Aventis Investigational Site Number 643006; 🇷🇺 Moscow, Russian Federation

Sanofi-Aventis Investigational Site Number 643007; 🇷🇺 Smolensk, Russian Federation

Sanofi-Aventis Investigational Site Number 710006; 🇿🇦 Centurion, South Africa

Sanofi-Aventis Investigational Site Number 710003; 🇿🇦 Pretoria, South Africa

Sanofi-Aventis Investigational Site Number 250003; 🇫🇷 Montpellier Cedex 05, France

Sanofi-Aventis Investigational Site Number 276001; 🇩🇪 Schwerin, Germany

Sanofi-Aventis Investigational Site Number 643004; 🇷🇺 Samara, Russian Federation

Sanofi-Aventis Investigational Site Number 643005; 🇷🇺 Nizhny Novgorod, Russian Federation

Sanofi-Aventis Investigational Site Number 643002; 🇷🇺 St-Petersburg, Russian Federation

Sanofi-Aventis Investigational Site Number 250002; 🇫🇷 Toulouse, France

Sanofi-Aventis Investigational Site Number 276002; 🇩🇪 Berlin, Germany

Sanofi-Aventis Investigational Site Number 276005; 🇩🇪 Leipzig, Germany

Sanofi-Aventis Investigational Site Number 710005; 🇿🇦 Cape Town, South Africa

Sanofi-Aventis Investigational Site Number 276007; 🇩🇪 München, Germany

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

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

Sanofi-Aventis Investigational Site Number 152005; 🇨🇱 Santiago, Chile

Sanofi-Aventis Investigational Site Number 152004; 🇨🇱 Santiago, Chile

Sanofi-Aventis Investigational Site Number 152003; 🇨🇱 Santiago, Chile

Sanofi-Aventis Investigational Site Number 152006; 🇨🇱 Santiago, Chile

Sanofi-Aventis Investigational Site Number 152008; 🇨🇱 Vina Del Mar, Chile

Sanofi-Aventis Investigational Site Number 643010; 🇷🇺 Saint-Petersburg, Russian Federation

Sanofi-Aventis Investigational Site Number 643011; 🇷🇺 St-Petersburg, Russian Federation

Sanofi-Aventis Investigational Site Number 643001; 🇷🇺 St.-Petersburg, Russian Federation

Sanofi-Aventis Investigational Site Number 276006; 🇩🇪 Mannheim, Germany

Sanofi-Aventis Investigational Site Number 752005; 🇸🇪 Stockholm, Sweden

Sanofi-Aventis Investigational Site Number 710004; 🇿🇦 Somerset West, South Africa

Sanofi-Aventis Investigational Site Number 752002; 🇸🇪 Lund, Sweden

Sanofi-Aventis Investigational Site Number 752004; 🇸🇪 Linköping, Sweden

Sanofi-Aventis Investigational Site Number 752003; 🇸🇪 Malmö, Sweden

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

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

Sanofi-Aventis Investigational Site Number 152001; 🇨🇱 Santiago, Chile

Sanofi-Aventis Investigational Site Number 233001; 🇪🇪 Tallinn, Estonia

Sanofi-Aventis Investigational Site Number 233002; 🇪🇪 Tallinn, Estonia

Sanofi-Aventis Investigational Site Number 233004; 🇪🇪 Tallinn, Estonia

Sanofi-Aventis Investigational Site Number 246001; 🇫🇮 Helsinki, Finland

Sanofi-Aventis Investigational Site Number 246003; 🇫🇮 Helsinki, Finland

Sanofi-Aventis Investigational Site Number 246004; 🇫🇮 Turku, Finland