Status:
COMPLETED
Long Term Safety and Tolerability of SR58611 in Patients With Major Depressive Disorder
Lead Sponsor:
Sanofi
Conditions:
Major Depressive Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary objective: \- To evaluate the long-term safety and tolerability of SR58611A (amibegron) patients with major depressive disorder (MDD). Secondary objective: \- To determine plasma concentrat...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- patients as defined by Diagnosis and Statistical Manual of Mental Disorders, recurrent episode for at least 1 month prior to entry into the study, and with a total score of \> 18 on the Hamilton Depression Rating Scale (HAM-D) 17-items.
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
527 Patients enrolled
Trial Details
Trial ID
NCT00855530
Start Date
September 1 2005
End Date
July 1 2007
Last Update
March 25 2009
Active Locations (11)
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1
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
2
Sanofi-Aventis Administrative Office
Santiago, Chile
3
Sanofi-Aventis Administrative Office
Athens, Greece
4
Sanofi-Aventis Administrative Office
Causeway Bay, Hong Kong