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临床试验/NCT03807167
NCT03807167已完成不适用

Apathy in Late Life Depression: New Biomarkers Using Actimetry and Magnetic Resonance Imaging

Rennes University Hospital11 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2019年8月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
试验地点
11
主要终点
Actimetry

研究概览

简要总结

Old age (> 60 years) is at high risk to develop major depression disorders (MDD). MDD doubles the risk for subsequent cognitive disorders and dementia. Apathy (i.e. the lack of motivation) is a core problem in depression in older age and is frequently associated with cognitive decline in people who have mild cognitive disorders. The investigator propose here to combine actimetry (the measurement of motor activity using a simple device worn at the wrist) and brain imaging to show that it's possible to measure apathy using actimetry in a population of elders with MDD. Having shown that apathy can reliably be measured with actimetry and that it is associated with brain abnormalities, the investigator will be able to test whether actimetry can predict cognitive decline in elders with MDD and can be routinely used in a day-to-day medical practice.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 60 years and above
  • Major depressive disorder (either late-onset or early onset)
  • Ambulatory settings
  • Both uni and bipolar depression will be considered Healthy controls
  • 60 years and above
  • No psychiatric disorders, including no major depressive disorder
  • No non-inclusion criteria

排除标准

  • Patients and healthy controls
  • Major cognitive disorders (< 125 on the Mattis dementia rating scale and a major cognitive disorders diagnostic according to the DSM5 (Diagnostic and Statistical Manual of Mental Disorders) criteria).
  • Other neurological conditions (stroke, Parkinson's disease and seizures), severe and inflammatory disorders (ex: severe arthroses which limits movements, spondylarthritis)
  • Severe sarcopenia: speed walk < 1 meter/second
  • Extrapyramidal syndrome
  • High suicidal risk
  • Anti-psychotic prescription
  • Participant who are unable to provide clear consent, under legal protection
  • MRI contra-indication

结局指标

主要结局

Actimetry

时间窗: 3 days

Measure of actimetry: immobility, transfer, walking, movement given by the accelerometer

次要结局

  • cortical thickness(at Day 3 (+/- 2 days))
  • diffusion tensor imaging,(at Day 3 (+/- 2 days))
  • pulsatility.(at Day 3 (+/- 2 days))
  • grey matter density(at Day 3 (+/- 2 days))
  • Rest functional connectivity analysis(at Day 3 (+/- 2 days))

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (11)

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