Lv Xiaozhen, Si Tianmei, Wang Gang, Wang Huali, Liu Qi, Hu Changqing, Wang Jing, Su Yunai, Huang Yu, Jiang Hui, Yu Xin
Peking University Sixth Hospital (Institute of Mental Health), Beijing, China.
National Clinical Research Center for Mental Disorders & Key Laboratory for Mental Health, Ministry of Health, Peking University, Beijing, China.
BMC Psychiatry. 2016 Jul 15;16:240. doi: 10.1186/s12888-016-0953-z.
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.
METHODS/DESIGN: 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.
重度抑郁症（MDD）是一种常见的精神障碍，患病率高、复发频繁且疾病负担沉重。遗传、环境及其相互作用在MDD的发生发展中起重要作用。MDD患者通常在临床症状和体征上表现出广泛差异，而MDD的诊断相对主观。不同亚型的MDD患者对治疗的反应差异很大，只有一半患者对第一种抗抑郁药有充分反应。本研究旨在定义MDD的亚型，开发多维诊断测试和综合预测指标，以提高诊断准确性并促进对MDD患者的个性化干预。
方法/设计：这是一项多中心、多阶段的前瞻性研究。本研究的第一阶段是病例对照研究，旨在探索MDD的发病危险因素，然后使用1200例MDD患者和1200名健康对照通过一套问卷来定义MDD的亚型。第二阶段是诊断测试，旨在使用来自第一阶段的600例MDD患者和300名健康对照通过一套问卷、神经心理学评估和一系列生物标志物来识别和重复潜在指标以辅助MDD诊断。第三阶段是一项为期96周的纵向研究，包括8周急性期治疗和88周稳定期治疗，旨在使用来自第一阶段的600例MDD患者通过一套问卷、神经心理学评估和一系列生物标志物来确定治疗后第8周MDD治疗效果的总体预测指标，并探索接下来2年MDD预后的预测指标。主要结局指标是17项汉密尔顿抑郁量表总分的变化。
本研究将为提高MDD诊断准确性并在临床实践中促进对MDD患者的个性化治疗提供有力且合适的证据。
ClinicalTrials.gov：NCT02023567；注册日期：2013年12月。
