EUCTR2009-013789-17-FI进行中(未招募)不适用
Efficacy and safety of agomelatine (25 mg/day with potential blinded adjustment to 50 mg/day) for 12 weeks in non-depressed out-patients with Generalized Anxiety Disorder.A 12-week randomised, double-blind, placebo-controlled, with escitalopram (10 mg/day with potential blinded adjustment to 20 mg/day) as validator, 3-arm parallel groups, international multicenter study.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 390
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
- 性别
- All
入选标准
- •Outpatients aged between 18 (or legal age of majority) and 65 years (inclusive), male or female, fulfilling DSM-IV-TR criteria for GAD diagnosis
- •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 390
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients suffering of all types of current anxiety disorders other than GAD within 6 months prior to selection
- •Patients meeting DSM-IV-TR current diagnosis of psychiatric disorder other than GAD within 6 months prior to selection
- •Women of childbearing potential without effective contraception as well as pregnant or breastfeeding women
- •Any relevant clinical abnormality detected during physical examinations, ECG or laboratory tests likely to interfere with the study conduct or evaluations
研究者
相似试验
进行中(未招募)
不适用
Efficacy and safety of agomelatine (25 mg/day with potential adjustment at 50 mg/day) given orally compared to placebo, in addition to a mood stabilizer in Bipolar I patients with a current major depressive episode. An 8-week randomised, double-blind, controlled, parallel groups study followed by a double-blind extension treatment period up to 1 year.EUCTR2005-004881-17-ATInstitut de Recherches Internationales Servier300
进行中(未招募)
不适用
Efficacy and safety of agomelatine (25 mg/day with potential adjustment at 50 mg/day) given orally compared to placebo, in addition to a mood stabilizer in Bipolar I patients with a current major depressive episode. An 8-week randomised, double-blind, controlled, parallel groups study followed by a double-blind extension treatment period up to 1 year.EUCTR2005-004881-17-FIInstitut de Recherches Internationales Servier300
进行中(未招募)
1 期
Efficacy and safety of agomelatine (25 mg/day with potential adjustment at 50 mg/day) given orally compared to placebo, in addition to a mood stabilizer in Bipolar I patients with a current major depressive episode. An 8-week randomised, double-blind, controlled, parallel groups study followed by a double-blind extension treatment period up to 1 year.Major depressive episode in the framework of bipolar disorderMedDRA version: 7.0Level: PTClassification code 10004939EUCTR2005-004881-17-DKInstitut de Recherches Internationales Servier300
进行中(未招募)
不适用
Efficacy and safety of agomelatine (25 mg/day with potential adjustment at 50 mg/day) given orally compared to placebo, in addition to a mood stabilizer in Bipolar I patients with a current major depressive episode. An 8-week randomised, double-blind, controlled, parallel groups study followed by a double-blind extension treatment period up to 1 year.EUCTR2005-004881-17-NLInstitut de Recherches Internationales Servier300
进行中(未招募)
1 期
Efficacy and safety of agomelatine (25 mg/day with potential blinded adjustment at 50 mg/day) for 12 weeks in non-depressed out-patients with Generalized Anxiety Disorder. A 12-week randomised, double-blind, placebo-controlled, with paroxetine (20 mg/day with potential progressive blinded adjustment to 40 mg/day) as validator, 3-arm parallel groups, international multicenter study.Generalized Anxiety DisorderMedDRA version: 11.0 Level: LLT Classification code 10018075 Term: <Manually entered code. Term in E.1.1>EUCTR2008-003421-17-CZInstitut de Recherches Internationales Servier
