跳至主要内容
临床试验/ISRCTN75061806
ISRCTN75061806已完成未知

Efficacy and safety of agomelatine (25-50 mg/day) for 12 weeks in patients with Generalized Anxiety Disorder: a randomised controlled trial

Institut de Recherches Internationales Servier (France)0 个研究点目标入组 510 人开始时间: 2012年8月7日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
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

入排标准

性别
All

入选标准

  • 1. Asian patients aged 18 years
  • 2. Fulfilling Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder diagnosis confirmed by the M.I.N.I. questionnaire and requiring a psychotropic treatment.
  • 3. Hamilton Anxiety Scale (HAM-A) total score >22

排除标准

  • 1. All types of current anxiety disorders (within 6 months prior to the selection visit) other than generalized anxiety disorder (GAD)
  • 2. Current diagnosis of any other psychiatric disorders than GAD or severe or uncontrolled organic disease
  • 3. Any clinically relevant abnormality detected during the physical examination, ECG, liver B ultrasound exams or laboratory tests likely to interfere with the study conduct or evaluations
  • 4. Pregnancy or breastfeeding women

研究者

发起方
Institut de Recherches Internationales Servier (France)

相似试验

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 periodMedDRA version: 17.0Level: PTClassification code 10018075Term: Generalised anxiety disorderSystem Organ Class: 10037175 - Psychiatric disordersGeneralized Anxiety Disorder
EUCTR2012-003699-37-PLInstitut de Recherches Internationales Servier510
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 periodMedDRA version: 14.1Level: PTClassification code 10018075Term: Generalised anxiety disorderSystem Organ Class: 10037175 - Psychiatric disordersGeneralized Anxiety Disorder
EUCTR2012-003699-37-CZInstitut de Recherches Internationales Servier510
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 periodMedDRA version: 17.0Level: PTClassification code 10018075Term: Generalised anxiety disorderSystem Organ Class: 10037175 - Psychiatric disordersGeneralized Anxiety Disorder
EUCTR2012-003699-37-HUInstitut de Recherches Internationales Servier510
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.MedDRA version: 14.1Level: PTClassification code 10018075Term: Generalised anxiety disorderSystem Organ Class: 10037175 - Psychiatric disordersGeneralized Anxiety Disorder
EUCTR2012-003699-37-SKInstitut de Recherches Internationales Servier510
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.Generalized Anxiety Disorder
EUCTR2012-003699-37-FIInstitut de Recherches Internationales Servier510