NCT01034995

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 580 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depression

Interventions

Type	Name	Description
DRUG	SSR125543	Pharmaceutical form: capsule Route of administration: oral
DRUG	escitalopram	Pharmaceutical form: encapsulated tablets Route of administration: oral
DRUG	placebo	Pharmaceutical form: capsule Route of administration: oral

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2009-12-18
• Last updated: 2011-04-14

Locations

73 sites across 12 countries: Belgium, Canada, Chile, Estonia, Finland, France, Germany, Netherlands, Russia, Slovakia, South Africa, Sweden