A Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed-dose Study Evaluating the Efficacy and Safety of Lu AA21004 (15 and 20 mg/Day) in the Acute Treatment of Adult Patients With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 607
- 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, tolerability and the safety of two fixed doses of vortioxetine in the treatment of major depressive disorder.
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
- •The patient has recurrent MDD as the primary diagnosis according to DSM-IV-TR™ criteria (classification code 296.3x)
- •The patient has a MADRS total score >=26
- •The patient has a CGI-S score >=4
- •The patient has had the current episode of MDE for >3 months
排除标准
- •Any current anxiety psychiatric disorder as defined in the DSM-IV TR
- •Current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV TR
- •Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV TR
- •Use of any psychoactive medication 2 weeks prior to screening and during the study
- •The patient is at significant risk of suicide or has a score >=5 on Item 10 (suicidal thoughts) of the MADRS, or has attempted suicide within 6 months prior to the Screening Visit
- •Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Duloxetine: 60 mg
Active Reference
干预措施: Duloxetine (Drug)
Placebo
干预措施: Placebo (Drug)
Vortioxetine: 15 mg
干预措施: Vortioxetine (Lu AA21004) (Drug)
Vortioxetine: 20 mg
干预措施: Vortioxetine (Lu AA21004) (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
- Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)(Week 8)
- Change From Baseline in MADRS Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score ≥20(Baseline and Week 8)
- Change From Baseline in ASEX Total Score After 8 Weeks of Treatment(Baseline and Week 8)
- Change in Clinical Status Using CGI-I Score at Week 8(Week 8)
- Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)(Week 8)
- Change From Baseline in SDS Total Score After 8 Weeks of Treatment(Baseline and Week 8)
- Potential Discontinuation Symptoms After Abrupt Discontinuation of Treatment With Vortioxetine(Change from Week 8 in DESS total score analyzed at Week 10)