Status:
COMPLETED
Efficacy and Safety of One Single Dose 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 is to demonstrate the antidepressant efficacy on the Hamilton depression rating scale (HAM-D) of amibegron (SR58611) 700 mg/day compared to placebo in the treatment of patients with ...
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 :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT00825019
Start Date
September 1 2003
End Date
December 1 2004
Last Update
March 25 2009
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807