drugset / Trial / NCT01110889

Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder

NCT01110889

Phase 3 Completed 582 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder. This study includes an 8-week double-blind phase.

Timeline

Start
2010-05
Primary completion
2011-07
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Agomelatine Small molecule 0.5 mg Other
Subject Agomelatine Small molecule 1 mg Other