NCT00811252已完成3 期
Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed Dose Study Comparing the Efficacy and Safety of [Vortioxetine] Lu AA21004 in Acute Treatment of Major Depressive Disorder in Elderly Patients
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
- 453
- 主要终点
- Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment
研究概览
简要总结
To assess the efficacy of Vortioxetine (5 mg daily) versus placebo in the acute treatment of depression by means of the change from baseline in the 24-item Hamilton Depression Scale (HAM-D24) total score after 8 weeks of double-blind treatment in elderly patients.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Diagnosis of recurrent Major Depressive Episode (MDE) according the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria with:
- •Reported duration of the current episode of at least 4 weeks
- •MADRS total score >=26
- •At least one previous MDE before the age of 60 years
排除标准
- •Mini Mental State Exam (MMSE) <24
- •Any current anxiety disorder as defined in the DSM-IV-TR
- •Current or past 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
- •Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR
- •Presence or history of a clinically significant neurological disorder (including epilepsy)
- •Neurodegenerative disorder (Alzheimer's disease, Parkinson disease, multiple sclerosis, Huntington disease, etc)
- •Any Axis II disorder that might compromise the study
- •Significant risk of suicide according to the investigator's opinion, or has a score >=5 on item 10 of the MADRS or has made a suicide attempt in the previous 6 months
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Vortioxetine 5 mg
Experimental
干预措施: Vortioxetine (Lu AA21004) (Drug)
Duloxetine 60 mg
Other
Active reference
干预措施: Duloxetine (Drug)
结局指标
主要结局
Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment
时间窗: Baseline and Week 8
The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.
次要结局
- Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment(Baseline and Week 6)
- Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment(Baseline and Week 4)
- Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment(Baseline and Week 2)
- Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment(Baseline and Week 1)
- Change From Baseline in MADRS Total Score After 8 Weeks of Treatment(Baseline and 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 in Clinical Status Using CGI-I Score at Week 8(Week 8)
- Change From Baseline in GDS Total Score After 8 Weeks of Treatment(Baseline and Week 8)
- Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score)(Week 8)
- Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)(Week 8)
- Risk of Suicidality Using C-SSRS Scores(Up to 8 weeks)
研究者
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