NCT01607125已完成1 期
Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Exploratory Study Investigating the Effects of [Vortioxetine] Lu AA21004 on Cognition and BOLD fMRI Signals in Subjects Remitted From Depression and Controls
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with executive function (working memory)
研究概览
简要总结
The purpose of this study is to determine if Vortioxetine 20 mg/day will lead to changes in neural activity (BOLD signal), as measured using fMRI, in brain areas associated with executive functioning and memory during cognitive task performances compared to placebo in subjects remitted from depression and in controls, and to explore if Vortioxetine will lead to improved cognitive performance in the absence of depression.
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
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects must have:
- •a Hamilton Depression Rating Scale (HAM-D17) total score ≤ 7
- •Subjects remitted from depression must:
- •be in remission from recurrent depression having suffered from at least two previous Major Depressive Episodes (MDEs)
- •have received prescribed treatment with an antidepressant or a recognised psychotherapy for depression for a previous MDE
- •report present subjective cognitive dysfunction
- •not have been treated with antidepressants or received other psychotherapy for depression for at least six weeks prior to screening visit
- •Control group subjects must:
- •have no history of MDEs
- •have no history of MDEs in a biological parent or other first degree relative as reported by the subject
- •not report present subjective cognitive dysfunction
- •never have been treated with antidepressants or psychotherapy
排除标准
- •The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Vortioxetine
Experimental
干预措施: Vortioxetine (Lu AA21004) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with executive function (working memory)
时间窗: Day 1 to Day 13
Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with spatial memory
时间窗: Day 1 to Day 13
次要结局
- Effect of Vortioxetine on cognitive performance (executive function, memory, speed of processing, attention, cognitive flexibility) and emotional processing(Day 1 to Day 13)
研究者
研究点 (1)
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