drugset / Trial / NCT00825058
Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine
RandomizedParallel-groupDouble-blindTreatment
Summary
Primary objective : * To demonstrate the antidepressant efficacy on the Hamilton Depression Rating Scale of SR58611A 700mg/day compared with placebo in the treatment of patients with a recurrent major depressive episode. Secondary objectives: * To assess the safety profile of SR58611A 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.
Timeline
- Start
- 2003-11
- Primary completion
- 2004-05
- Completion
- 2004-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Paroxetine | Small molecule | 20 mg | Oral |
| Subject | amibegron | Small molecule | 350 mg | Oral |