drugset / Trial / NCT01606384

Evaluation of the Potential Effects of SSR149415 on the Hypothalamic-pituitary-adrenal Axis in Outpatients With Major Depressive Disorder

NCT01606384

Phase 2 Completed 100 enrolled Sanofi
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

EvaluationDrugModalityDoseRoute
Subject NELIVAPTAN Small molecule 100 mg Oral
Subject NELIVAPTAN Small molecule 250 mg Oral