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

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

Summary

The main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in combination with escitalopram 10mg once daily compared to saredutant placebo in combination with escitalopram 10mg once daily in patients with major depressive disorder. This study also includes a double-placebo group (saredutant placebo in combination with escitalopram placebo).

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

Details

• Lead Sponsor: Sanofi
• Treatments: Citalopram; Dexetimide

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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.