Efficacy and safety of agomelatine (10 or 25 mg/day) in non-depressed out-patients with generalized anxiety disorder: A 12-week, double-blind, placebo-controlled study

Autor: Oleg S. Chaban, Celine Gruget, Christian de Bodinat, Antti Ahokas, A. Avedisova, F. Picarel-Blanchot, Marek Jarema, Dan J. Stein, Valérie Olivier, Livia Vavrusova
Rok vydání: 2017
Předmět:
Zdroj: European Neuropsychopharmacology. 27:526-537
ISSN: 0924-977X
DOI: 10.1016/j.euroneuro.2017.02.007
Popis: Agomelatine is efficacious in reducing symptoms and preventing relapse in placebo-controlled trials in generalised anxiety disorder (GAD). Nevertheless, fixed dose studies of agomelatine in GAD have not been undertaken. To determine the minimally effective optimal dose of agomelatine in GAD, the efficacy of two doses of agomelatine (10 and 25mg/day) was investigated in a 12-week, placebo-controlled, double-blind, international study in patients with a primary diagnosis of GAD. The primary outcome measure was the Hamilton Anxiety scale (HAM-A). The study was undertaken in 35 clinical centers in Finland, Russia, Poland, Slovakia and Ukraine from August 2013 to January 2015. 131 out-patients were included in the agomelatine 10mg group, 139 in the agomelatine 25mg group, and 142 in the placebo group. Both doses of agomelatine were associated with significant decreases in the HAM-A at week 12 (difference versus placebo of 7.16±1.00 at 10mg and 11.08±0.98 at 25mg, p
Databáze: OpenAIRE