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

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Paroxetine

Criteria

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