Inflammation and Blood Brain Barrier Integrity as Biomarkers of Suicidal Behavior
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Level of blood S100B assayed in the 3 groups, a marker of cerebral and vascular lesions.
研究概览
简要总结
Recent studies have revealed an association between history of suicide attempt and inflammatory markers in both the cerebrospinal fluid and the plasma. Post mortem studies have shown an increase in microglial activation in the brain tissue of suicide victims. However the relationship between peripheral and central inflammation in suicide is probably mediated by complex biological processes that are yet elucidated. An increase of blood S100B levels (biomarker of neurovascular damage; PMID 14530574) has been reported in adolescents with suicidal ideation vs. controls and independently of psychiatric disorder.
The investigators hypothesize that peripheral inflammation may alter the blood brain barrier, which normally acts as a filter to ensure proper neuronal functioning, in suicidal patients.
They propose to investigate peripheral inflammation, neurovascular permeability and miRNAs in suicidal behavior pathophysiology as biomarkers of suicidal behavior in depression
详细描述
150 participants will be enrolled, divided into 3 groups:
- 50 Suicide attempters, i.e. currently depressed patients with a suicide attempt within the 8 last days (with a maximal lifetime number of 3 previous suicide attempts, including the most recent);
- 50 Affective controls, i.e. currently depressed patients without any lifetime history of suicide attempt;
- 50 Healthy controls (age- and gender-matched to patients' groups) with no lifetime history of psychiatric disorders.
The protocol includes two visits for patients (suicide attempters and affective controls) and only one visit (inclusion) for healthy controls.
The first visit is the inclusion visit (Day 0-Day 8). Day 0 is the date of the last suicide attempt for the suicide attempters group and the date of signature of the consent for the affective control and healthy control groups. All the visit exams will be performed within 8 days after Day 0.
The second visit takes place one month +/- one week after inclusion. At each visit, a clinical assessment will be performed to characterise psychopathology and suicidal characteristics. Blood samples will be obtained in order to measure inflammatory markers. An MRI will be performed on order to study white matter microstructure and brain functional connectivity networks.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Level of blood S100B assayed in the 3 groups, a marker of cerebral and vascular lesions.
时间窗: At 1 month follow-up
次要结局
- Extraction of small and long RNA(At 1 month follow-up)
- FACS analysis on fresh blood(At 1 month follow-up)
- White matter microstructure analysis(At 1 month follow-up)
- Cytokines' concentration by multiplex ELISA (pg/ml)(At 1 month follow-up)
- Cerebral blood analysis(At 1 month follow-up)
- Specific proteins measurement (pg/ml)(At 1 month follow-up)
- Test of the capacity of leukocytes isolated from patients to provoke vascular inflammation and BBB permeabilization(At 1 month follow-up)
- Brain functional connectivity networks analysis : extraction of resting state functional connectivity metrics from functional atlas or by voxel(At 1 month follow-up)
- Cerebral morphometric extraction (3DT1): automatic segmentation(At 1 month follow-up)