drugset / Trial / NCT00855530
Long Term Safety and Tolerability of SR58611 in Patients With Major Depressive Disorder
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Primary objective: \- To evaluate the long-term safety and tolerability of SR58611A (amibegron) patients with major depressive disorder (MDD). Secondary objective: \- To determine plasma concentrations of SR58878 (the active metabolite of SR58611A), for pharmacokinetic population analyses, to evaluate the quality of life (QoL) in patients with MDD, and to evaluate the efficacy of amibegron in patients with MDD.
Timeline
- Start
- 2005-09
- Primary completion
- 2007-07
- Completion
- 2007-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | amibegron | Small molecule | 300 mg | Oral |