A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Two Doses of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 639
- 主要终点
- Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator
研究概览
简要总结
This study will evaluate the efficacy of Vortioxetine in the prevention of relapse of major depressive episodes in patients who responded to open-label treatment with Vortioxetine.
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
- •Major Depressive Episode (MDE) as the primary diagnosis according to DSM-IV TR criteria
- •At least one other MDE before the current one
- •Moderate to severe depression
排除标准
- •Any current psychiatric disorder other than Major Depressive Disorder (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
- •Randomisation Criteria: Patients in remission (MADRS total score <=10) at both Week 10 and Week 12
- •Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Vortioxetine: 5 or 10 mg
干预措施: Vortioxetine (Lu AA21004) (Drug)
结局指标
主要结局
Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator
时间窗: Within first 24 weeks of the double-blind period
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 Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind Treatment(Double-blind Baseline and Week 24 of the double-blind period)
- Relapse During the Entire Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator(Within 64 weeks of the double-blind period)
- Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment(Double-blind Baseline and Week 24 of the double-blind period)
- Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind Treatment(Double-blind Baseline and Week 24 of the double-blind period)
- Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment(Double-blind Baseline and Week 24 of the double-blind period)
- Proportion of Responders at Week 24 of the Double-blind Period (Response Defined as a >=50% Reduction in MADRS Total Score From Open-label Baseline)(Week 24 of the double-blind period (Counted From Open-label Baseline))
- Proportion of Remitters at Week 24 of the Double-blind Period (Remission Defined as a MADRS Total Score <=10)(Week 24 of the double-blind period)
- Change From Double-blind Baseline in SDS Total Score at Week 24 of the Double-blind Period(Week 24 of the double-blind period (Counted From Double-blind Baseline))