NCT00694304已完成3 期
A Long-term, Open-label, Flexible-dose, Extension Study Evaluating the Safety and Tolerability of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 535
- 主要终点
- Number of Patients With Adverse Events (AEs)
研究概览
简要总结
The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed 8-week acute treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients who completed 8-week short-term treatment study for Major Depressive Episode, NCT00635219 / 11984A
排除标准
- •Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Ed., Text revision (DSM-IV TR)
- •Female patients of childbearing potential who are not using effective contraception
- •Use of any psychoactive medication
- •Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Vortioxetine
Experimental
干预措施: Vortioxetine (Lu AA21004) (Drug)
结局指标
主要结局
Number of Patients With Adverse Events (AEs)
时间窗: Baseline to end of the 4-week safety follow-up period
Percentage of Patients Who Withdrew Due to Intolerance to Treatment
时间窗: Baseline to Week 52
次要结局
- Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment(Baseline and Week 52)
- Change From Baseline in CGI-S Score After 52 Weeks of Treatment(Baseline and Week 52)
- Change From Baseline in MADRS Total Score After 52 Weeks of Treatment(Baseline and Week 52)
- Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment(Baseline and Week 52)
- Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)(Week 52)
- Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)(Week 52)
- Proportion of Patients With a MADRS Total Score >=22 After 52 Weeks of Treatment(Baseline and Week 52)
- Change From Baseline in SDS Total Score After 52 Weeks of Treatment(Baseline and Week 52)
研究者
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