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

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

—

Outcome

Mixed primary results

paper Agomelatine 25 mg/d was more efficacious based on the HDRS(17) total score (P = .01) compared to placebo throughout the treatment period PMID 20361916 ↗

paper for agomelatine 50 mg/d, statistically significant reduction in HDRS(17) total score could be observed from weeks 2 to 6 but not at week 8 (P = .144). PMID 20361916 ↗

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	—

Indications