Multi-Dimensional Diagnosis,Individualized Therapy,and Management Technique for Major Depressive Disorder:Based on Clinical and Pathological Characteristics
- Conditions
- Depressive Disorder
- Interventions
- Combination Product: fluoxetine + cognitive-behavioral treatment（CBT）Combination Product: physical treatment+fluoxetine+amfebutamoneCombination Product: Cognitive behavior treatment +fluvoxamineDrug: Lithium+fluvoxamineCombination Product: fluvoxamine + lithium + physical therapyDrug: Mirtazapine/SNRIsCombination Product: mirtazapine+ Cognitive behavior treatmentCombination Product: mirtazapine + SNRIs + physical therapyOther: TAU(treat as usual)
- Registration Number
- NCT03219008
- Lead Sponsor
- Shanghai Mental Health Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 800
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Depression/underload 2 fluoxetine + cognitive-behavioral treatment（CBT） This group would be treated with fluoxetine combined with cognitive behavior treatment Depression/underload 3 fluoxetine + Amfebutamone This group would be treated with fluoxetine and amfebutamone from the minimum dosage. Depression/underload 4 physical treatment+fluoxetine+amfebutamone This group would be treated with fluoxetine + physical treatment to help to cure depressive disorder. Atypical 2 Cognitive behavior treatment +fluvoxamine This group would be treated with fluoxetine + cognitive behavior treatment Atypical 3 Lithium+fluvoxamine This group would be treated with fluvoxamine + lithium from the minimum dosage. Atypical 4 fluvoxamine + lithium + physical therapy This group would be treated with fluvoxamine + lithium + physical treatment Anxiety/somatization 1 Mirtazapine/SNRIs This group would be treated with mirtazapine/selective serotonin-norepinephrine reuptake inhibitors（SNRIs） from the minimum dosage. Anxiety/somatization 2 mirtazapine+ Cognitive behavior treatment This group would be treated with mirtazapine/SNRIs + cognitive behavior treatment. Anxiety/somatization 3 mirtazapine + SNRIs This group would be treated with mirtazapine + SNRIs from the minimum dosage. Anxiety/somatization 4 mirtazapine + SNRIs + physical therapy This group would be treated with mirtazapine + SNRIs + physical treatment. treatment as usual(TAU) TAU(treat as usual) The investigators recommend therapy strategies according to accessible methods. Depression/underload 1 Fluoxetine This group would be treated with fluoxetine from the minimum dosage. Atypical 1 Fluvoxamine This group would be treated with fluvoxamine from the minimum dosage.
- Primary Outcome Measures
Name Time Method Change from baseline in levels of microRNA，apolipoproteins, meta ion (Composite measure) at 2,4,6,8,12 week. The potential biomarkers in our study include microRNA,apolipoproteins,metallic ion etc.We use quantitative analysis technique to test miRNA,proteins and metallic ion by patients' blood and urines before interventions and after interventions.
- Secondary Outcome Measures
Name Time Method the gray matter volume, change from baseline neuroimaging data at 2,4,6,8,12 week The investigators in our study use voxel-based morphometry (VBM8)to record the gray matter volume.
Neuroelectrophysiological examination: electroencephalogram(EEG) at baseline EEG is used to record individual's brain activity. The investigators in our study record individual's brain wave.
life event scale(LES) at baseline LES is one of the common questionnaires to evaluate individual's mental and stress stimulation in daily life.The investigators record the total scores of LES at baseline.
dysfunctional attitudes scales(DAS) at baseline The DAS is a self-report scale composed of 40 items to assess typical, stable depressogenic attitudes or schemas that make individuals vulnerable to depression. The investigators in our study record the total scores od DAS at baseline.
Hamilton Depression Scale(HADA) scores,reductive ratio at 0,2,4,6,8,12 week. HADA,created by Hamilton in 1960,is one of the most common questionnaires to evaluate the severity of depression and the efficiency of medicine. we adopt the Hamilton Depression Scale(HADA)to evaluate different medicines efficiency by analyzing reductive ratio.The investigators record the total scores of HADA at baseline and 2,4,6,8,12 week.
Patient health questionnaire(PHQ-9):the clinical remission ratio change from baseline PHQ-9 total scores at 2,4,6,8,12 week PHQ-9 is a self-report scale composed of 9 items to evaluate the state of depression.The investigators in our study record the total scores of PHQ-9 at 0,2,4,6,8,12 week to analyze the clinical remission ratio.
social support scale(SSS) at baseline SSS is one of the common questionnaires to evaluate individual's social support and social relationship network to explore the correlation between social support and mental health. the investigators in our study record the total scores of SSS at baseline.
Neuroelectrophysiological examination:electrocardiograph(ECG) at baseline. ECG is used to record the individual's cardiac cycle.
fractional amplitudes of low-frequency fluctuation(fLAFF) change from baseline neuroimaging data at 2,4,6,8,12 week The investigators in our study use region-of-interest(ROI)to record fLAFF.
Trial Locations
- Locations (1)
ShanghaiMHC
🇨🇳Shanghai, China