An Eight-week Study Evaluating the Efficacy of a 100mg Dose of Saredutant Once Daily, in Elderly Patients With Major Depressive Disorder
Completed · Phase 3 · Has a placebo group
Conditions studied: Depressive Disorder
In brief
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 quality of life in patients with major depressive disorder.To evaluate safety and tolerability of 24 weeks of additional treatment in patients completing the initial 8-week treatment period.
Key facts
- Study ID
- NCT00415142
- Run by
- Sanofi
- People needed
- 393
- Starts
- 2006-12-01
- Expected to finish
- 2008-02-01
- Last updated by the study team
- 2016-05-24
Who can join
Age: 60 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
Where it is running
- Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
- Sanofi-Aventis Administrative Office — Zagreb, Croatia
- Sanofi-Aventis Administrative Office — Prague, Czechia
- Sanofi-Aventis Administrative Office — Paris, France
- Sanofi-Aventis Administrative Office — México, Mexico
- Sanofi-Aventis Administrative Office — Moscow, Russia
- Sanofi-Aventis Administrative Office — Bromma, Sweden
- Sanofi-Aventis Administrative Office — Istanbul, Turkey (Türkiye)
Full record on ClinicalTrials.gov
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