title: The establishment of the objective diagnostic markers and personalized medical intervention in patients with major depressive disorder: rationale and protocol.
abstract: 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.
authors.affiliation: 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.
authors.forename: Xiaozhen
authors.initials: X
authors.lastname: Lv
authors.affiliation: 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.
authors.forename: Tianmei
authors.initials: T
authors.lastname: Si
authors.affiliation: Beijing Anding Hospital, Capital Medical University, Beijing, China.
authors.forename: Gang
authors.initials: G
authors.lastname: Wang
authors.affiliation: 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.
authors.forename: Huali
authors.initials: H
authors.lastname: Wang
authors.affiliation: 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.
authors.forename: Qi
authors.initials: Q
authors.lastname: Liu
authors.affiliation: Beijing Anding Hospital, Capital Medical University, Beijing, China.
authors.forename: Changqing
authors.initials: C
authors.lastname: Hu
authors.affiliation: 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.
authors.forename: Jing
authors.initials: J
authors.lastname: Wang
authors.affiliation: 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.
authors.forename: Yunai
authors.initials: Y
authors.lastname: Su
authors.affiliation: National Engineering Research Center for Software Engineering, Peking University, Beijing, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Huang
authors.affiliation: National Engineering Research Center for Software Engineering, Peking University, Beijing, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Jiang
authors.affiliation: Peking University Sixth Hospital (Institute of Mental Health), Beijing, China. yuxin@bjmu.edu.cn.|National Clinical Research Center for Mental Disorders & Key Laboratory for Mental Health, Ministry of Health, Peking University, Beijing, China. yuxin@bjmu.edu.cn.
authors.forename: Xin
authors.identifier: 0000-0003-0934-3168
authors.initials: X
authors.lastname: Yu
mesh_terms: D000293:Adolescent; D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use*; D015415:Biomarkers; D016022:Case-Control Studies; D002985:Clinical Protocols; D003865:Major Depressive Disorder / Q000175:diagnosis* / Q000188:drug therapy; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D057285:Precision Medicine; D011379:Prognosis; D011446:Prospective Studies; D012307:Risk Factors; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000928:Antidepressive Agents; D015415:Biomarkers; D017367:Selective Serotonin Reuptake Inhibitors
keywords: Diagnostic; Major depressive disorder; Personalized treatment; Subtype