EUCTR2006-006540-54-GB进行中（未招募）1 期
Efficacy of agomelatine (25 to 50 mg/day) given orally on improvement of subjective sleep in patients with Major Depressive Disorder. A randomised, double-blind, flexible-dose international multicentre study with parallel groups versus escitalopram (10 to 20mg/day). Twelve-week treatment plus double-blind extension for 12 weeks.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Outpatients between 18 (or minimum legal age) and 70 years of age (included), male or female, fulfilling DSM-IV criteria for Major Depressive Disorder
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •All types of depression other than Major Depressive Disorder
- •Severe or uncontrolled organic disease, likely to interfere with the conduct of the study
- •Women of childbearing potential without effective contraception (oral contraceptive pill, intra-uterine contraceptive device, contraceptive implant or condom) as well as pregnant or breastfeeding women
研究者
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Efficacy of agomelatine given orally on improvement of subjective sleep in patients with major depressive disorder: a randomised, double-blind, flexible-dose international multicentre study with parallel groups versus Selective Serotonin Reuptake Inhibitor (SSRI) twelve week treatment plus double-blind extension for 12 weeksMental and Behavioural DisordersDepressive episodeMajor Depressive DisorderISRCTN55250367Institut de Recherches Internationales Servier (France)324
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进行中（未招募）
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进行中（未招募）
1 期
Efficacy of agomelatine (25 to 50 mg/day) given orally on quality of remission in elderly depressed patients, after a 12-week treatment period.A randomised, double-blind, flexible-dose international multicentre study with parallel groups versus paroxetine (20 to 30 mg/day).Twelve-week treatment plus optional continuation for 12 weeks.MedDRA version: 3.3Level: P.T.Classification code 10025453Major Depressive DisorderEUCTR2005-002388-95-ESaboratorios Servier S.L. (For Spain only)400