A Phase 3 interventional study of saredutant (SR48968) and paroxetine in Depressive Disorder, Major, sponsored by Sanofi. Completed at 8 sites in 8 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-05-26.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
The main purpose of this study is to evaluate the efficacy of saredutant 100mg or 30mg once daily in combination with paroxetine 20mg once daily compared to saredutant placebo in combination with paroxetine 20mg once daily in patients with major depressive disorder. The study also includes a double-placebo group (saredutant placebo in combination with paroxetine placebo).
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 825 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
combined saredutant 100mg and paroxetine 20mg once daily for a maximum of 8 weeks
Drug: saredutant (SR48968) · Drug: paroxetine
combined saredutant 30mg and paroxetine 20mg once daily for a maximum of 8 weeks
Drug: saredutant (SR48968) · Drug: paroxetine
paroxetine 20mg and saredutant placebo once daily for a maximum of 8 weeks
Drug: paroxetine · Drug: placebo
Saredutant placebo and paroxetine placebo once daily for one week during screening period and maximum of 8 weeks for the active phase
Drug: placebo
oral administration,capsules
oral administration, capsules
oral administration, capsules
Change from baseline in the Hamilton Depression Rating Scale (HAM-D) total score
Time frame: 8 weeks
Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ) total score
Time frame: weeks
Change from baseline in the Clinical Global Impression severity of illness score
Time frame: 8 weeks
Change from baseline in the HAM-D depressed mood item scores
Time frame: 8 weeks
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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Sanofi