Status:
COMPLETED
An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Elderly Patients With Depression
Lead Sponsor:
Sanofi
Conditions:
Depressive Disorder
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of SR58611A in elderly patients with depression.The primary objective is to evaluate the efficacy of a 700 mg dose of SR58611A compared ...
Eligibility Criteria
Inclusion
- Outpatients or inpatients
- Major Depressive Disorder (MDD) with a recurrent Major Depressive Episode (MDE) according to DSM IV-TR criteria.
- MADRS score equal of above 22.
Exclusion
- Patients with a current significant risk of suicide in the investigator's clinical judgment.
- The duration of the current depressive episode is greater than 2 years.
- Patients whose current depressive episode is secondary to a general medical condition
- Patients with a lifetime history according to MINI at screening of:bipolar disorder, psychotic disorder, antisocial personality disorder.
- Patients with a current history according to MINI at screening of anxiety disorders, alcohol dependence or abuse or substance dependence or abuse
- Patients with severe or unstable concomitant medical conditions.
- History of seizures other than a single childhood febrile seizure.
- Patients with abnormal thyroid functioning.
- Patients with clinically significant ECG findings at screening.
- Patients who have taken an investigational drug in the last 3 months prior to screening.
- Any subject who has previously participated in a SR58611A protocol.
- Patients with Mini-Mental State Examination (MMSE) score \< 25 at screening.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT00319709
Start Date
April 1 2006
End Date
August 1 2007
Last Update
March 12 2009
Active Locations (5)
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1
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
2
Sanofi-Aventis Administrative Office
Helsinki, Finland
3
Sanofi-Aventis Administrative Office
Bucharest, Romania
4
Sanofi-Aventis Administrative Office
Belgrade, Serbia