Status:
COMPLETED
An Eight-week Study Evaluating the Efficacy of a 100mg Dose of Saredutant Once Daily, in Elderly Patients With Major Depressive Disorder
Lead Sponsor:
Sanofi
Conditions:
Depressive Disorder
Eligibility:
All Genders
60-64 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the efficacy of saredutant in the treatment of Major Depressive Disorder in elderly patients.To evaluate the tolerability, safety and efficacy on disability and...
Eligibility Criteria
Inclusion
- Diagnosis of major depressive disorder, recurrent, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria (296.3) and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI).
Exclusion
- Total score of less than 23 on the MADRS.
- HAM-D total score less than 17.
- Duration of the current depressive episode less than 1 month or greater than 2 years.
- Patients with an Mini Mental State Examination score of less than 23.
- Patients with a history or presence of bipolar disorders or psychotic disorders.
- Patients with alcohol/substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
- Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, fluoxetine within 1 month, monoamine oxidase inhibitors within 4 weeks, other antidepressants, or mood-stabilizer (lithium, anticonvulsants) within 1 week.
- The investigator will evaluate whether there are other reasons why a patient may not participate
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
393 Patients enrolled
Trial Details
Trial ID
NCT00415142
Start Date
December 1 2006
End Date
February 1 2008
Last Update
May 24 2016
Active Locations (8)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Zagreb, Croatia
3
Sanofi-Aventis Administrative Office
Prague, Czechia
4
Sanofi-Aventis Administrative Office
Paris, France