Primary objective is to demonstrate the antidepressant efficacy on the Hamilton depression rating scale (HAM-D) of amibegron (SR58611) 700 mg/day compared to placebo in the treatment of patients with a recurrent major depressive episode (MDD). Secondary objective is to assess the safety profile of amibegron 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
306
oral administration of 2x 700 mg/day in 12h intervals
oral administration in 12h intervals
oral administration of 20 mg/day
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
change from baseline of the total score of the HAM-D 17 items
Time frame: 6 weeks
HAM-D subscores, HAMD responders and remitters, HAM-A total score and subscores
Time frame: 6 weeks
Montgomery-Asberg Depression Rating Scale (MADRS) total score
Time frame: 6 weeks
clinical global impression (CGI) severity and improvement scores
Time frame: 6 weeks
patient global impression (PGI) improvement score
Time frame: 6 weeks
social and occupational functioning assessment scale (SOFAS) score
Time frame: 6 weeks
AEs, Arizona Sexual Experience Scale (ASEX),
Time frame: 6 weeks
laboratory parameters, physical examination findings, ECG parameters, change of vital signs, body weight
Time frame: 6 weeks
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