A Phase 2 interventional study of SSR125543 and escitalopram in Major Depression, sponsored by Sanofi. Completed at 73 sites in 12 countries. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2011-04-14.
Sponsored by Sanofi · Phase 2, Interventional, and Treatment
Primary Objective:
Secondary Objectives:
This duration of this trial is 11 weeks.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's planned enrollment of 580 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, 117 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
1 capsule of SSR125543 20 mg + 1 capsule of placebo
Drug: SSR125543
1 capsule of SSR125543 50 mg + 1 capsule of placebo
Drug: SSR125543
2 capsules of SSR125543 50 mg
Drug: SSR125543
1 capsule of escitalopram 10 mg + 1 capsule of placebo
Drug: escitalopram
2 capsules of placebo
Drug: placebo
Pharmaceutical form: capsule Route of administration: oral
Pharmaceutical form: encapsulated tablets Route of administration: oral
Pharmaceutical form: capsule Route of administration: oral
Change from baseline (Day -1) to Day 56 in the 17-item HAM-D total score
Time frame: 8 weeks
Change from baseline in HAM-D depressed mood item
Time frame: 8 weeks
Change from baseline in HAM-D responders (50% improvement)
Time frame: 8 weeks
Changes from baseline in the HAM-D core and factor scores
Time frame: 8 weeks
Changes from baseline in the Montgomery-Asberg depression rating scale (MADRS) total score
Time frame: 8 weeks
Changes from baseline in the Clinical Global Impression (CGI) Severity of Illness score
Time frame: 8 weeks
This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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Sanofi