An Eight-week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive Disorder (COMPASS)
Depressive Disorder, Major
About this trial
This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Major Depressive Disorder, Depression, Major Depressive Episode, Antidepressant
Eligibility 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
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Placebo Comparator
Saredutant 100mg and Paroxetine 20 mg
Saredutant 30mg and Paroxetine 20mg
Paroxetine 20 mg and saredutant placebo
Placebo
combined saredutant 100mg and paroxetine 20mg once daily for a maximum of 8 weeks
combined saredutant 30mg and paroxetine 20mg once daily for a maximum of 8 weeks
paroxetine 20mg and saredutant placebo once daily for a maximum of 8 weeks
Saredutant placebo and paroxetine placebo once daily for one week during screening period and maximum of 8 weeks for the active phase