NCT00629551

An Eight-week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive Disorder

An Eight-week, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Saredutant (100 mg and 30 mg) Once Daily in Combination With Paroxetine 20 mg Once Daily Compared to Saredutant Placebo in Combination With Paroxetine 20 mg Once Daily in Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 825 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the efficacy of saredutant 100mg or 30mg once daily in combination with paroxetine 20mg once daily compared to saredutant placebo in combination with paroxetine 20mg once daily in patients with major depressive disorder. The study also includes a double-placebo group (saredutant placebo in combination with paroxetine placebo).

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	saredutant (SR48968)	oral administration,capsules
DRUG	paroxetine	oral administration, capsules
DRUG	placebo	oral administration, capsules

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-03-06
• Last updated: 2016-05-26

Locations

8 sites across 8 countries: United States, Chile, Estonia, Germany, Mexico, Russia, South Africa, South Korea