Abstract:
According to the World Health Organization (WHO), major depressive disorder (MDD) is the fourth leading cause of disability worldwide and the second most common disease after cardiovascular events. Approximately 280 million people live with MDD, with incidence varying by age and gender (female to male ratio of approximately 2:1). Although a variety of antidepressants are available for the different forms of MDD, there is still a high degree of individual variability in response and tolerability. Given the complexity and clinical heterogeneity of these disorders, a shift from \"canonical treatment\" to personalized medicine with improved patient stratification is needed. OPADE is a non-profit study that researches biomarkers in MDD to tailor personalized drug treatments, integrating genetics, epigenetics, microbiome, immune response, and clinical data for analysis. A total of 350 patients between 14 and 50 years will be recruited in 6 Countries (Italy, Colombia, Spain, The Netherlands, Turkey) for 24 months. Real-time electroencephalogram (EEG) and patient cognitive assessment will be correlated with biological sample analysis. A patient empowerment tool will be deployed to ensure patient commitment and to translate patient stories into data. The resulting data will be used to train the artificial intelligence/machine learning (AI/ML) predictive tool.
摘要:
根据世界卫生组织(WHO)重度抑郁症(MDD)是全球范围内导致残疾的第四大原因,也是仅次于心血管事件的第二大常见疾病.大约有2.8亿人患有MDD,发病率因年龄和性别而异(男女比例约为2:1)。尽管有多种抗抑郁药可用于不同形式的MDD,在反应和耐受性方面仍然存在高度的个体差异。鉴于这些疾病的复杂性和临床异质性,需要从“规范治疗”转变为个性化医疗,并改善患者分层。OPADE是一项非营利性研究,研究MDD中的生物标志物以定制个性化药物治疗,整合遗传学,表观遗传学,微生物组,免疫反应,和临床数据进行分析。在6个国家(意大利,哥伦比亚,西班牙,荷兰,土耳其)24个月。实时脑电图(EEG)和患者认知评估将与生物样本分析相关。将部署患者授权工具,以确保患者承诺并将患者故事转化为数据。生成的数据将用于训练人工智能/机器学习(AI/ML)预测工具。