Major Depression and Messenger RNAs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- to compare gene expression difference for 21 candidate genes, of which 12 were already investigated, in 2 groups of subjects
研究概览
简要总结
Major Depressive Episode (MDE) affects nearly 15% of the general population. In a preliminary study, the investigators identified 12 genes whose expression was either altered between patient and control samples and/or between first patient samples and samples from the same patients obtained 8 weeks later. However, this study did not assess evolution of these alterations beyond an 8-week window and only 2 time points were considered. The investigators aim to compare gene expression difference for 21 candidate genes, of which 12 were already investigated, in 2 groups of subjects. MDE and control samples will be analyzed across a large time window to draw a better picture of the complex progression during MDE.
详细描述
Rational:
Major Depressive Episode (MDE) affects nearly 15% of the general population. To date, its pathophysiology remains unclear and treatment effects are often inconsistent. Therefore, it is challenging to make a valid prognosis for depression and identification of biomarkers is an important way of improving patient's treatment. Messenger RNAs (mRNAs) could be potential biological markers. Several studies have shown quantitative variations in peripheral blood mononuclear cells (PBMC) during MDE. These variations are state dependent and/or correlated with clinical measures.
In a preliminary study, the investigators identified 12 genes whose expression was either altered between patient and control samples and/or between first patient samples and samples from the same patients obtained 8 weeks later. However, this study did not assess evolution of these alterations beyond an 8 weeks window and only 2 time points were considered.
Objective:
the investigators aim to compare gene expression difference for 21 candidate genes, of which 12 were already investigated, in 2 groups of subjects. MDE and control samples will be analyzed across a large time window to draw a better picture of the complex progression during MDE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hamilton score on depression scale (HAMD-17) > 20;
- •No schizophrenia or bipolar disorder or disturbs delirious or evolutionary severe somatic pathology;
- •Taken care by a psychiatric department.
- •Arm control:
- •No history of psychiatric pathology or evolutionary severe somatic pathology
排除标准
- •Hamilton score on depression scale (HAMD-17) < or = 20;
- •With signs of schizophrenia or bipolar disorder or disturbs delirious;
- •With evolutionary severe somatic pathology.
- •Arm control:
- •With signs of psychiatric pathology or evolutionary severe somatic pathology.
研究组 & 干预措施
Major Depressive Episode (MDE)
20 subjects with major depressive episode will be included and followed during a 6 months interval which includes 4 visits (at the inclusion, 2 and 8 weeks later and finally 6 month later)
干预措施: blood sample (Biological)
Control
20 subjects without major depressive episode will be included and followed during a 6 months interval which includes 4 visits (at the inclusion, 2 and 8 weeks later and finally 6 month later)
干预措施: blood sample (Biological)
结局指标
主要结局
to compare gene expression difference for 21 candidate genes, of which 12 were already investigated, in 2 groups of subjects
时间窗: 6 months
次要结局
未报告次要终点