Status:
COMPLETED
An Eight-week Study of SSR411298 as Treatment for Major Depressive Disorder in Elderly Patients
Lead Sponsor:
Sanofi
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to evaluate the efficacy of 3 fixed doses of SSR411298 (10, 50 or 200 mg daily) compared to placebo, in elderly patients with Major Depressive Disorder (MDD), ba...
Detailed Description
The study period for a participants is approximately 10 weeks including a screening up to 1 week, 8-week treatment and 1-week follow-up.
Eligibility Criteria
Inclusion
- Elderly patient with recurrent Major Depressive Disorder
Exclusion
- Duration of current depressive episode greater than 2 years;
- Mild depression as measured by standard clinical research scales;
- Cognitive disturbance;
- Significant suicide risk;
- Other psychiatric conditions that would obscure the results of the study;
- History of failure to respond to antidepressant treatment.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
527 Patients enrolled
Trial Details
Trial ID
NCT00822744
Start Date
December 1 2008
End Date
February 1 2010
Last Update
March 15 2013
Active Locations (7)
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1
Sanofi-Aventis Administrative Office
Santiago, Chile
2
Sanofi-Aventis Administrative Office
México, Mexico
3
Sanofi-Aventis Administrative Office
Bucharest, Romania
4
Sanofi-Aventis Administrative Office
Moscow, Russia