Clinical trial NCT02023567: Objective Diagnostic Markers and Personalized Intervention in MDD Patients
Official title: The Establishment of the Objective Diagnostic Markers and Personalized Medical Intervention in Patients With Major Depressive Disorders (MDD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Disorder, Major
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Capital Medical University
name: Peking Union Medical College Hospital
name: Tianjin Medical University General Hospital
name: Tianjin Anding Hospital
name: The First Hospital of Hebei Medical University
name: First Hospital of China Medical University
name: Dalian Seventh People's Hospital
name: The First Affiliated Hospital of Shanxi Medical University
First posted: 2013-12-30
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Major depressive disorder (MDD) is one of the most common psychiatric disorders, with high recurrence rate, suicide rate and disability rate. It's reported that the global burden caused by MDD will be up to the second rank among all the disease burdens by 2020. China is also confronted with the daunting challenges against MDD. It's assessed that the monthly incidence of MDD is 6.1%, non-hospitalizing rate reaches up to 92% and the non-treatment rate is approximate 95%. However, to date, the pathogenesis of MDD is obscure and the current therapies don't work well. Therefore, it's urgent and critical to elucidate the pathogenesis of MDD, to develop early diagnostic criteria and effective intervention in MDD. Considering the diversity of weights on genetic factor and environmental factor in MDD, in this project, the investigators aim firstly to explore the effect of "genetic-environmental interaction"on the pathogeny of MDD for classifying MDD into "genetic type", "environmental type" and "others" based on a case-control study. We next conduct the neurobiological, neurocognitive and psycho-behavioral assessments among MDD, schizophrenia and healthy groups to screen the salient endophenotypes for establishing the diagnostic models of MDD . The investigators further analyse the changes of these indicators after 8 weeks'medication to select the potential predictors for therapeutic evaluations and interventional options in MDD patients. Finally, the investigators continue a 2-year follow-up study to test and verify the predictors of prognosis in MDD patients.


Eligibility criteria: 1. For MDD group:

   Inclusion criteria:
   * Age between 18-55, male or female;
   * The diagnosis of MDD consistent with DSM-IV (M.I.N.I)
   * First-episode or relapsed;
   * Certain ability of reading and writing to complete the questionnaire survey and psychological assessment.
   * All participants provide written confirmation of informed consent prior to engaging the study protocol.

   Exclusion criteria:
   * Current psychopathology or a history of neurologic conditions, including alcohol/substances dependence, the diagnosis of cognition impairment;
   * Severe somatic diseases, such as severe cardio-cerebral vascular diseases, respiratory diseases, liver diseases, kidney diseases, or malignant tumors;
   * Not signed the informed consent;
   * Been engaging other studies.
2. For Healthy control group

Inclusion criteria:

* age between 18 and 55 years at the time of enrollment;
* providing written confirmation of informed consent prior to engaging the study.

Exclusion criteria:

* lifetime or current diagnosis of any mental diseases;
* severe somatic diseases, such as severe cardio-cerebral vascular diseases, respiratory diseases, liver diseases, kidney diseases, or malignant tumors;
* not signed the informed consent;
* been engaging other studies.

Primary outcomes:
measure: The changes of HAMD total score at 8 weeks from baseline
timeFrame: week 0,2,4,8
Secondary outcomes:
measure: The changes of HAMA total score at 8 weeks from baseline
timeFrame: week 0,2,4,8
measure: The change of CGI score at 8 weeks from baseline
timeFrame: week 0,2,4,8
measure: The prognosis after the intervention
timeFrame: Up to 2 years
measure: Number of participants with serious and non-serious adverse events
timeFrame: Up to two years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anding Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Beijing
city: Shijiazhuang
country: China
facility: Hebei Medical University First Hospital
state: Hebei
city: Dalian
country: China
facility: Dalian Seventh People's Hospital
state: Liaoning
city: Shenyang
country: China
facility: First Hospital of China Medical University
state: Liaoning
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Anding Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
affiliation: Peking University Sixth Hospital
name: Xin Yu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin J, Su Y, Lv X, Liu Q, Wang G, Wei J, Zhu G, Chen Q, Tian H, Zhang K, Wang X, Zhang N, Yan H, Wang Y, Yu X, Si T. Childhood adversity, adulthood adversity and suicidal ideation in Chinese patients with major depressive disorder: in line with stress sensitization. Eur Arch Psychiatry Clin Neurosci. 2022 Aug;272(5):887-896. doi: 10.1007/s00406-021-01375-4. Epub 2022 Jan 5.
citation: Cui F, Liu Q, Lv X, Leonhart R, Tian H, Wei J, Zhang K, Zhu G, Chen Q, Wang G, Wang X, Zhang N, Huang Y, Si T, Yu X. Severe sleep disturbance is associated with executive function impairment in patients with first-episode, treatment-naive major depressive disorders. BMC Psychiatry. 2021 Apr 19;21(1):198. doi: 10.1186/s12888-021-03194-2.
citation: Lin J, Su Y, Lv X, Liu Q, Wang G, Wei J, Zhu G, Chen Q, Tian H, Zhang K, Wang X, Zhang N, Wang Y, Yu X, Si T. Perceived stressfulness mediates the effects of subjective social support and negative coping style on suicide risk in Chinese patients with major depressive disorder. J Affect Disord. 2020 Mar 15;265:32-38. doi: 10.1016/j.jad.2020.01.026. Epub 2020 Jan 10.
citation: Lin JY, Huang Y, Su YA, Yu X, Lyu XZ, Liu Q, Si TM. Association between Perceived Stressfulness of Stressful Life Events and the Suicidal Risk in Chinese Patients with Major Depressive Disorder. Chin Med J (Engl). 2018 Apr 20;131(8):912-919. doi: 10.4103/0366-6999.229898.
citation: Lv X, Si T, Wang G, Wang H, Liu Q, Hu C, Wang J, Su Y, Huang Y, Jiang H, Yu X. The establishment of the objective diagnostic markers and personalized medical intervention in patients with major depressive disorder: rationale and protocol. BMC Psychiatry. 2016 Jul 15;16:240. doi: 10.1186/s12888-016-0953-z.