Status:
COMPLETED
An Eight-week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive Disorder
Lead Sponsor:
Sanofi
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 paro...
Eligibility Criteria
Inclusion
- Outpatients with recurrent Major Depressive Disorder
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
825 Patients enrolled
Trial Details
Trial ID
NCT00629551
Start Date
February 1 2008
End Date
February 1 2009
Last Update
May 26 2016
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Santiago, Chile
3
Sanofi-Aventis Administrative Office
Tallinn, Estonia
4
Sanofi-Aventis Administrative Office
Berlin, Germany