NCT03287986已完成不适用
Brain Markers of Suicide Risk and Psychological Pain in Elderly Depressed Patients
Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年8月18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
- 60
- 试验地点
- 1
- 主要终点
- Brain functional activity during unfairness
研究概览
简要总结
The main objective of this study is to show MRI functional and structural differences between depressed elderly patients with a history of attempted suicide compared to depressed elderly patients with no history of attempted suicide and to elderly subjects with no personal history of depression or attempted suicide (healthy controls).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient must have given their free and informed consent and signed the consent form
- •be a member or beneficiary of a health insurance plan
- •aged 60 years-old or more
- •must be right-handed
- •with a diagnosis of a current major depressive episode of moderate to severe severity according to diagnostic criteria.
- •with or without a personal history of attempted suicide during life
- •hospitalized or followed by a consultant in the department of Psychiatry of Nîmes University Hospital or in the Sophoras private clinic
排除标准
- •The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- •under safeguard of justice
- •refuses to sign the consent
- •It is impossible to give the subject informed information
- •Current psychotic symptoms.
- •Bipolar disorder.
- •The subject presents an acute somatic decompensation incompatible with the realization of this study.
- •The patient presents a mental confusion or a known Mini Mental State Examination score <
- •Central neurological disease known in particular degenerative pathology, severe cranial trauma and severe cerebrovascular disease.
- •Schizophrenia and other known psychotic disorders.
- •Electroconvulsive therapy in the 12 months prior to study
- •Inability to perform neuropsychological tests because of a language problem, poor understanding, a major tremor, inability to sit still, a major sight problem that cannot be corrected, or other severe cognitive impairment
- •Contra-indication to magnetic resonance imaging (MRI): ferromagnetic implant in the body, piercing, claustrophobia, inability to remain elongated for 45 minutes.
结局指标
主要结局
Brain functional activity during unfairness
时间窗: Day 0
Contrast in BOLD signal measured by 3T-Magnetic Resonance Imaging (MRI) during the fair vs unfair trials of the Ultimatum Game
次要结局
- Brain functional connectivity(Day 0)
- Correlation of MRI measures with psychological pain measures(Day 0)
- Brain structural volumes(Day 0)
- Brain structural connectivity(Day 0)
研究者
研究点 (1)
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