Status:
COMPLETED
Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS)
Lead Sponsor:
Sanofi
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy of two fixed doses of SR58611A (175 mg q12 and 350 mg q12) compared to placebo in patients with Major Depressive Disorder (MDD) using paroxetine (20 mg qd) as positive control...
Eligibility Criteria
Inclusion
- Patient with Major Depressive Disorder diagnosed according to Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR
- Patient meets criteria for a recurrent Major Depressive Episode (MDE)
- Patient meets severity assessments of depression specified by the study
Exclusion
- Patient is at immediate risk for suicidal behavior
- Patient is with a unstable medical condition
- Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
- Patient has taken concomitant treatment that may interfere with valid collection or interpretation of study data
- Patient has been treated with non-pharmacologic therapy intended to treat depression in the past 6 months
- Patient has been treated with paroxetine (Paxil) within the previous 6 months
- Patient is pregnant or breastfeeding, or likely to become pregnant during the course of the study
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
680 Patients enrolled
Trial Details
Trial ID
NCT00385307
Start Date
September 1 2006
End Date
November 1 2007
Last Update
March 25 2009
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807