Official Title: “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”

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: March 2009

Intervention(s) in this Clinical Trial

• Drug: saredutant (SR48968)
  • once daily
• Drug: paroxetine
  • once daily
• Drug: placebo
  • once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • combined saredutant 100mg and paroxetine 20mg
• Experimental: 2
  • combined saredutant 30mg and paroxetine 20mg
• Active Comparator: 3
  • paroxetine 20mg
• Placebo Comparator: 4

Primary Measures

• Change from baseline in Hamilton Depression Rating Scale total score
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• Change from baseline in the Changes in Sexual Functioning Questionnaire total score
  • Time Frame: 8 weeks
    Safety Issue?: No
• Change from baseline in the Clinical Global Impression severity of illness score
  • Time Frame: 8 weeks
    Safety Issue?: No

Inclusion Criteria:

• Outpatients with recurrent Major Depressive Disorder

Exclusion Criteria:

• Symptoms of current depressive episode for less than 30 days or more than 2 years
• Mild depression, as measured by standard clinical research scales
• Significant suicide risk
• Lack of sexual activity (including masturbation)
• Other psychiatric conditions that would obscure the results of the study
• History of failure to respond to antidepressant treatment
• Pregnancy or breast-feeding

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

ICD CSD Study Director Sanofi-Aventis  

Overall Contact: Public Registry ICD  GV-Contact-us@sanofi-aventis.com

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00629551

Study ID Number: EFC10438

ClinicalTrials.gov Identifier: NCT00629551

Health Authority: United States: Food and Drug Administration