EVALUATION PROSPECTIVE DE L'AIDE AU DIAGNOSTIC ET AU TRAITEMENT PAR BIOMARQUEURS SANGUINS CHEZ DES PATIENTS DRUG-NAÏFS AMBULATOIRES SOUFFRANT DE DEPRESSION
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- psychiatric symptomatology
研究概览
简要总结
This is an observational (non-interventional) prospective study, carried out in drug-naïve outpatients who start a treatment with escitalopram, fluoxetine, sertraline or quetiapine. Five blood samples are collected (i.e. before initiating the drug, and then after 1, 2, 4 and 8 weeks of treatment). It does not affect the choice or the treatment dose. The primary objective of this study is to measure the association between the EDIT-B® editing signature and response to pharmacological treatment in drug-naïve patients. Results of this research could provide an aid to early diagnosis, optimize pharmacological treatment and guide clinical practice towards individualized treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult drug-naïve outpatients suffering from depression and/or bipolar disorders who start a pharmacological treatment with escitalopram, fluoxetine, sertraline or quetiapine and who gave his written informed consent to participate in the present study.
排除标准
- •Any patient without capacity of discernment or with harmful use of psychoactive substances
结局指标
主要结局
psychiatric symptomatology
时间窗: At baseline, 1,2,4,8 weeks
self- and hetero-questionnaire psychiatric scales
EDIT-B profiling
时间窗: At baseline, 1,2,4,8 weeks
Measurement of RNA editing over time
次要结局
未报告次要终点