The establishment of the objective diagnostic markers and personalized medical intervention in patients with major depressive disorder: rationale and protocol.
The establishment of the objective diagnostic markers and personalized medical intervention in patients with major depressive disorder: rationale and protocol.
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DOI：
10.1186/s12888-016-0953-z
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发表时间：
2016-07-15
期刊：
影响因子：
4.4
通讯作者：
Yu X
中科院分区：
文献类型：
--
作者：
Lv X;Si T;Wang G;Wang H;Liu Q;Hu C;Wang J;Su Y;Huang Y;Jiang H;Yu X
重性抑郁障碍（Major Depression Disorders，MDD）是一种常见的精神疾病，患病率高，复发率高，疾病负担重。遗传、环境及其相互作用在MDD的发生发展中起着重要作用。MDD患者的临床症状和体征差异较大，诊断相对主观。不同亚型的MDD患者的治疗反应差异很大，只有一半对第一种抗抑郁药有充分的反应。本研究旨在明确MDD的亚型，建立多维度的诊断测试和联合预测指标，以提高MDD诊断的准确性，促进MDD患者的个性化干预。这是一项多中心、多阶段的前瞻性研究。本研究的第一阶段为病例对照研究，采用问卷调查的方法，对1200例MDD患者和1200例健康对照者进行调查，探讨MDD发生的危险因素，确定MDD的亚型。第二阶段为诊断性试验，采用问卷调查、神经心理学评估和一系列生物标志物，对第一阶段的600例MDD患者和300例健康对照者进行识别和复制，以辅助MDD诊断。第三阶段为96周纵向研究，包括8周急性期治疗和88周稳定期治疗，目的是在治疗后第8周确定MDD治疗有效性的总体预测因素，并通过一套问卷、神经心理学评估和一系列生物标志物，对第一阶段的600例MDD患者进行2年预后预测。主要观察指标为汉密尔顿抑郁量表总分的变化。本研究将为临床实践中提高MDD诊断的准确性和促进MDD患者的个体化治疗提供有力和合适的证据。ClinicalTrials.gov：NCT 02023567;注册日期：2013年12月。
Major depressive disorders (MDD) is a common mental disorder with high prevalence, frequent relapse and associated with heavy disease burden. Heritability, environment and their interaction play important roles in the development of MDD. MDD patients usually display a wide variation in clinical symptoms and signs, while the diagnosis of MDD is relatively subjective. The treatment response varies substantially between different subtypes of MDD patients and only half respond adequately to the first antidepressant. This study aims to define subtypes of MDD, develop multi-dimension diagnostic test and combined predictors for improving the diagnostic accuracy and promoting personalized intervention in MDD patients. This is a multi-center, multi-stage and prospective study. The first stage of this study is a case–control study, aims to explore the risk factors for developing MDD and then define the subtypes of MDD using 1200 MDD patients and 1200 healthy controls with a set of questionnaire. The second stage is a diagnostic test, aims to indentify and replicate the potential indicators to assist MDD diagnosis using 600 MDD patients and 300 healthy controls from the first stage with a set of questionnaire, neuropsychological assessment and a series of biomarkers. The third stage is a 96-week longitudinal study, including 8-week acute period treatment and 88-week stable period treatment, aims to identify overall predictors of treatment effectiveness on MDD at week 8 post treatment and to explore the predictors on MDD prognosis in the following 2 years using 600 MDD patients from the first stage with a set of questionnaire, neuropsychological assessment and a series of biomarkers. The primary outcome measure is the change of the total score of 17-Item Hamilton Rating Scale for Depression. This study will provide strong and suitable evidence for enhancing the accuracy of MDD diagnosis and promoting personalized treatment for MDD patients in clinical practice. ClinicalTrials.gov: NCT02023567; registration date: December 2013.