A Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed-dose Study Evaluating the Efficacy and Safety of Three Dosages of [Vortioxetine] Lu AA21004, in Acute Treatment of Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 766
- 主要终点
- Change From Baseline in MADRS Total Score After 8 Weeks of Treatment
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and the tolerability of three fixed doses of Vortioxetine in order to establish the appropriate clinical effective dose range in the treatment of Major Depressive Disorder (MDD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx)
- •Moderate to severe depression
- •Current MDE duration of at least 3 months
排除标准
- •Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
- •Any substance disorder within the previous 6 months
- •Female patients of childbearing potential who are not using effective contraception
- •Use of any psychoactive medication 2 weeks prior to screening and during the study
- •Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Vortioxetine: 5 mg
干预措施: Vortioxetine (Lu AA21004) (Drug)
Placebo
干预措施: Placebo (Drug)
Vortioxetine: 2.5 mg
干预措施: Vortioxetine (Lu AA21004) (Drug)
Vortioxetine: 10 mg
干预措施: Vortioxetine (Lu AA21004) (Drug)
Duloxetine: 60 mg
Active reference
干预措施: Duloxetine (Drug)
结局指标
主要结局
Change From Baseline in MADRS Total Score After 8 Weeks of Treatment
时间窗: Baseline and Week 8
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.
次要结局
- Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment(Baseline and Week 8)
- Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)(Week 8)
- Change in Clinical Status Using CGI-I Score at Week 8(Week 8)
- Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score >=20(Baseline and Week 8)
- Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)(Week 8)
- Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment(Baseline and Week 8)
- Change From Baseline in CGI-S Score After 8 Weeks of Treatment(Baseline and Week 8)
- Change From Baseline in ASEX Total Score After 8 Weeks of Treatment(Baseline and Week 8)
- Change From Baseline in SDS Total Score After 8 Weeks of Treatment(Baseline and Week 8)