Efficacy and safety of agomelatine (25mg/day with blinded potential adjustment to 50mg/day) versus escitalopram (10mg/day with blinded potential adjustment to 20mg/day) given orally for 12 weeks in non-depressed out-patients with severe Generalized Anxiety Disorder.A 12-week randomised, double-blind, versus escitalopram, 2-arm parallel groups, international multicenter study with a 9-month extension period

Institut de Recherches Internationales Servier0 个研究点目标入组 510 人开始时间: 2012年11月28日最近更新: 2016年3月14日

适应症

试验速览

暂无简介。

•-All patients selected will be aged between 18 (or legal age for majority in the country) and 65 years old inclusive, male or female, out-patients.
•-fulfilling DSM-IV-TR criteria for Generalized Anxiety Disorder confirmed by the M.I.N.I. structured interview and requiring a psychotropic treatment.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 510
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Patients with current anxiety disorders other than Generalized Anxiety Disorder according to DSM IV criteria.
•-Pregnant or breastfeeding women,
•-Women of childbearing potential without effective contraception (i.e. contraceptive pill, surgical sterilization, hormonal contraceptive injections, intra-uterine contraceptive device, contraceptive implant, patch or condom). Please note that vasectomy of the partner is not considered as an effective contraception method for the patient in the framework of clinical studies,
•-Patients not able to read and/or write,
•-Patients who have a suicide risk according to the investigator's judgment; or with a score > 3 on the MADRS item X or who have made a suicide attempt within the past year.

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