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

Phase 3 Completed 503 enrolled Novartis

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label phase.

Timeline

Start: 2006-12
Primary completion: 2008-01
Completion: —

Publications

Stahl SM, Fava M, Trivedi MH, Caputo A, Shah A, Post A. Agomelatine in the treatment of major depressive disorder: an 8-week, multicenter, randomized, placebo-controlled trial. J Clin Psychiatry. 2010 May;71(5):616-26. doi: 10.4088/JCP.09m05471blu. Epub 2010 Mar 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Agomelatine	Small molecule	25 mg	—
Subject	Agomelatine	Small molecule	50 mg	—

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

Summary

Timeline

Publications

Drugs

Indications