A Phase 3 interventional study of saredutant (SR48968) and placebo in Depressive Disorder, sponsored by Sanofi. Completed at 8 sites in 8 countries. Open to participants aged 60 Years to 64 Years. Per ClinicalTrials.gov, last updated 2016-05-24.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
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.
4,847 studies on the registry are indexed under Depressive Disorder; 509 are open to participants now.
This study's enrollment of 393 is above the median of 80 across 3,997 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.
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Exclusion Criteria:
The investigator will evaluate whether there are other reasons why a patient may not participate
Saredudant100 mg once daily for a maximum of 32 weeks
Drug: saredutant (SR48968)
Escitalopram 10 mg once daily for a maximum of 32 weeks
Drug: escitalopram
Placebo once daily for one week during screening phase and a maximum of 8 weeks during the acute phase
Drug: placebo
oral administration (capsules)
oral administration (capsules)
oral administration (capsules)
Change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.
Time frame: Day 56
Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score.
Time frame: Day 56
Change from baseline to Day 56 in the HAM-D depressed mood item score
Time frame: Day 56
Change from baseline to Day 56 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
Time frame: Day 56
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: SR 48968