Double-blind, Randomised, Placebo-controlled Study Comparing the Efficacy and Safety of Two Fixed Dosages of a Novel Antidepressant Compound to That of Placebo in Patients With Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 426
- 主要终点
- Change From Baseline in MADRS Total Score After 6 Weeks of Treatment
研究概览
简要总结
The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and tolerability of two fixed doses of Vortioxetine in the acute 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 65 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)
- •Current MDE duration of at least 3 months and less than 12 months
- •The patient has a MADRS total score >=30
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
Placebo
干预措施: Placebo (Drug)
Vortioxetine (Lu AA21004) 5 mg
干预措施: Vortioxetine (Lu AA21004) (Drug)
Vortioxetine (Lu AA21004) 10 mg
干预措施: Vortioxetine (Lu AA21004) (Drug)
Venlafaxine XL 225 mg
Active Reference
干预措施: Venlafaxine XL (Drug)
结局指标
主要结局
Change From Baseline in MADRS Total Score After 6 Weeks of Treatment
时间窗: Baseline and Week 6
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 CGI-S Score After 6 Weeks of Treatment(Baseline and Week 6)
- Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10)(Week 6)
- Change From Baseline in MADRS Total Score After 1 Week of Treatment(Baseline and Week 1)
- Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment(Baseline and Week 6)
- Change in Clinical Status Using CGI-I Score at Week 6(Week 6)
- Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)(Week 6)
- Change From Baseline in HAM-A Total Score After 6 Weeks of Treatment(Baseline and Week 6)