Status:
COMPLETED
Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine
Lead Sponsor:
Sanofi
Conditions:
Major Depressive Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Primary objective : * To demonstrate the antidepressant efficacy on the Hamilton Depression Rating Scale of SR58611A 700mg/day compared with placebo in the treatment of patients with a recurrent majo...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- patients suffering from a recurrent major depressive episode of at least moderate intensity (DSM-IV)
- patients have been hospitalized for the treatment of a previous episode, or a previous episode required antidepressant treatment(s)at the recommended dose level for at least 2 months.
- the duration of the current episode is of at least six weeks unless the severity of symptoms justifies shorter duration
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
317 Patients enrolled
Trial Details
Trial ID
NCT00825058
Start Date
November 1 2003
End Date
October 1 2004
Last Update
March 25 2009
Active Locations (8)
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1
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
2
Sanofi-Aventis Administrative Office
Zagreb, Croatia
3
Sanofi-Aventis Administrative Office
Prague, Czechia
4
Sanofi-Aventis Administrative Office
Tallinn, Estonia