drugset / Trial / NCT01606384
Evaluation of the Potential Effects of SSR149415 on the Hypothalamic-pituitary-adrenal Axis in Outpatients With Major Depressive Disorder
RandomizedParallel-groupDouble-blindTreatment
Summary
Primary Objective: \- To evaluate the effects of two fixed doses of SSR149415 (250 mg bid and 100 mg bid) on hypothalamic-pituitary-adrenal axis function in patients with major depressive disorder. Secondary Objectives: * To evaluate the tolerability and safety of SSR149415 in patients with major depressive disorder. * To evaluate the efficacy of two fixed doses of SSR149415 compared to placebo in patients with major depressive disorder. * To evaluate plasma concentrations of SSR149415.
Timeline
- Start
- 2006-12
- Primary completion
- 2007-08
- Completion
- 2007-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NELIVAPTAN | Small molecule | 100 mg | Oral |
| Subject | NELIVAPTAN | Small molecule | 250 mg | Oral |