Clinical trial NCT03219008: Multi-Dimensional Diagnosis,Individualized Therapy,and Management Technique for Major Depressive Disorder:Based on Clinical and Pathological Characteristics
Official title: Multi-dimensional Diagnosis,Individualized Therapy,and Management Technique for Major Depressive Disorder:Based on Clinical and Pathological Characteristics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Depressive Disorder
Keywords: depressive disorder
multi-dimensional diagnosis technique
individualized therapy
management technique
e-MBC
MBC
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Shanghai Jiao Tong University School of Medicine
name: Chinese Academy of Sciences
name: Shanxi Medical University
name: Central South University
name: Second Military Medical University
name: Peking University Sixth Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: First Affiliated Hospital of Kunming Medical University
name: Air Force Military Medical University, China
name: Zhejiang University
name: Wuhan Mental Health Centre
name: Corning Hospital, Shenzhen City
name: the First Specialized Subject Hospital of Harbin
name: Renmin Hospital of Wuhan University
name: Seventh People's Hospital of Hangzhou
name: Shandong Mental Health Center
First posted: 2017-07-17
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part 2: all patients before receiving any medicine treatment are divided into four groups which adopt different therapy strategies :treatment with fluvoxamine, fluoxetine, mirtazapine and treatment as usual(TAU).Meanwhile，patients with different subtypes of depressive disorder were randomly assigned to different therapy groups.Each therapy groups contains 50 participants.Therefore, the total sample size is 50\*12+200=800.

Part3:To find out efficiency of different kinds of therapy strategies.p=60%, error=5%,a-0.05,the amount of samples nearly is:867,considering the nearly 30% expulsion rate, the final total sample size is 867+260=1127.Therefore,sample size in each group is nearly 376.

Part4:p=60%,error=0.05, a=0.05, exculsion rate=30%,N=867+260=1127.the amount of samples of each group is 1127/3=nearly 400.
Primary purpose: TREATMENT

Brief summary: Major Depressive Disorder is one of the most common mental diseases,which increases health-care costs and the financial burden to families and societies. Considering its complex clinical symptoms and diversity of comorbidity, depressive disorder's recognition，diagnosis，and antihistone are based on symptomatology,which is lack of multidimensional diagnosis technique based on clinical pathological characteristics,as well as lack of individualized therapy strategy based on quantified evaluation. Besides, other physical diseases，such as nervous system diseases, cardiovascular diseases，endocrine diseases, have the high comorbidity of depressive disorder. However，there is no precise diagnosis technique or standardized therapy strategy. With all those taken into consideration,our study is aimed to adopt E-mental health and m-Health to explore multi-dimensional diagnosis, individualized therapy and management technique based on molecular biology,nerve electrophysiology，and neuroimaging technology etc.

Detailed description: Four parts included in our study:

Part 1:The research, development and verification of indicators based on biomarkers and clinical characteristics to guide the diagnosis and treatment of depressive disorders

1. to screen biomarkers, to explore its pathophysiology, and to analyze the correlation between clinical subtypes/characteristics and biomarkers.
2. To differentiate the subtypes of depressive disorder（depression/underload, atypical, anxiety/somatization) based on clinical symptoms and clinical assessement.
3. To establish personalized therapy strategies,and to explore tool kits for diagnosis and treatment based on biomarkers and clinical characteristics.
4. to choose appropriate indicators to monitor therapy and side effect by collecting and analyzing blood/imaging/neuropsychological data.

Part 2: The development,transition and application of hierarchical model diagnostic technique for physical diseases combined with depressive disorder.

1. to recruit patients with physical diseases combined with depressive disorder, and explore potential biomarkers.
2. To chose appropriate therapy strategies based on measurement based care（MBC）, providing hierarchical model diagnostic technique for patients.
3. To weigh therapy efficiency and adverse effect among different medicine therapy groups.

Part3: The development and application of comprehensive prevention， diagnosis,and intervention model of depressive disorder.

1. To explore and establish online screening and assistant diagnosis system for patients with depressive disorder.
2. research ,development and application of intelligent e-MBC. Part 4: The development,transition and application of e-MBC sharing platform.

Eligibility criteria: Inclusion Criteria:

* aged 18-65 years;
* clinical diagnosis of major depressive disorder;
* 17-Hamilton Depression Scale\>20;
* 14-Hamilton Anxiety Scale score\<7;
* outpatient treatment;
* first episode;
* medication-naive;

Exclusion Criteria:

* clinical diagnosis of schizophrenia, schizoaffective disorder;
* any prescription or psychotropic medications in the past 4 week;
* serious medical or neurological illness;
* current pregnancy or breastfeeding.

Primary outcomes:
measure: Change from baseline in levels of microRNA，apolipoproteins, meta ion (Composite measure)
timeFrame: at 2,4,6,8,12 week.
Secondary outcomes:
measure: Hamilton Depression Scale(HADA) scores,reductive ratio
timeFrame: at 0,2,4,6,8,12 week.
measure: Patient health questionnaire(PHQ-9):the clinical remission ratio
timeFrame: change from baseline PHQ-9 total scores at 2,4,6,8,12 week
measure: life event scale(LES)
timeFrame: at baseline
measure: social support scale(SSS)
timeFrame: at baseline
measure: dysfunctional attitudes scales(DAS)
timeFrame: at baseline
measure: the gray matter volume,
timeFrame: change from baseline neuroimaging data at 2,4,6,8,12 week
measure: fractional amplitudes of low-frequency fluctuation(fLAFF)
timeFrame: change from baseline neuroimaging data at 2,4,6,8,12 week
measure: Neuroelectrophysiological examination: electroencephalogram(EEG)
timeFrame: at baseline
measure: Neuroelectrophysiological examination:electrocardiograph(ECG)
timeFrame: at baseline.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: ShanghaiMHC
Study officials:
References:
citation: Liu H, Wu X, Wang Y, Liu X, Peng D, Wu Y, Chen J, Su Y, Xu J, Ma X, Li Y, Shi J, Yang X, Rong H, Forti MD, Fang Y. TNF-alpha, IL-6 and hsCRP in patients with melancholic, atypical and anxious depression: an antibody array analysis related to somatic symptoms. Gen Psychiatr. 2022 Sep 8;35(4):e100844. doi: 10.1136/gpsych-2022-100844. eCollection 2022.
citation: Wang Y, Liu X, Peng D, Wu Y, Su Y, Xu J, Ma X, Li Y, Shi J, Cheng X, Rong H, Fang Y. A Preliminary Study of Different Treatment Strategies for Anxious Depression. Neuropsychiatr Dis Treat. 2022 Jan 4;18:11-18. doi: 10.2147/NDT.S320091. eCollection 2022.
citation: Liu X, Wang Y, Peng D, Zhang H, Zheng Y, Wu Y, Su YA, Liu M, Ma X, Li Y, Shi J, Cheng X, Rong H, Fang Y. The Developmental and Translational Study on Biomarkers and Clinical Characteristics-based Diagnostic and Therapeutic Identification of Major Depressive Disorder: Study Protocol for a Multicenter Randomized Controlled Trial in China. Neuropsychiatr Dis Treat. 2020 Oct 9;16:2343-2351. doi: 10.2147/NDT.S271842. eCollection 2020.