EUCTR2012-003699-37-DE进行中（未招募）不适用
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
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
- 510
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
- •-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
排除标准
- •-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.
研究者
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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 periodMedDRA version: 17.0Level: PTClassification code 10018075Term: Generalised anxiety disorderSystem Organ Class: 10037175 - Psychiatric disordersGeneralized Anxiety DisorderEUCTR2012-003699-37-PLInstitut de Recherches Internationales Servier510
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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 periodMedDRA version: 14.1Level: PTClassification code 10018075Term: Generalised anxiety disorderSystem Organ Class: 10037175 - Psychiatric disordersGeneralized Anxiety DisorderEUCTR2012-003699-37-CZInstitut de Recherches Internationales Servier510
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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 periodMedDRA version: 17.0Level: PTClassification code 10018075Term: Generalised anxiety disorderSystem Organ Class: 10037175 - Psychiatric disordersGeneralized Anxiety DisorderEUCTR2012-003699-37-HUInstitut de Recherches Internationales Servier510
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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.MedDRA version: 14.1Level: PTClassification code 10018075Term: Generalised anxiety disorderSystem Organ Class: 10037175 - Psychiatric disordersGeneralized Anxiety DisorderEUCTR2012-003699-37-SKInstitut de Recherches Internationales Servier510
进行中（未招募）
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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.Generalized Anxiety DisorderEUCTR2012-003699-37-FIInstitut de Recherches Internationales Servier510