Multi-dimensional Diagnosis,Individualized Therapy,and Management Technique for Major Depressive Disorder:Based on Clinical and Pathological Characteristics
试验速览
- 阶段
- 4 期
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Change from baseline in levels of microRNA，apolipoproteins, meta ion (Composite measure)
研究概览
简要总结
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.
详细描述
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
- to screen biomarkers, to explore its pathophysiology, and to analyze the correlation between clinical subtypes/characteristics and biomarkers.
- To differentiate the subtypes of depressive disorder（depression/underload, atypical, anxiety/somatization) based on clinical symptoms and clinical assessement.
- To establish personalized therapy strategies,and to explore tool kits for diagnosis and treatment based on biomarkers and clinical characteristics.
- 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.
- to recruit patients with physical diseases combined with depressive disorder, and explore potential biomarkers.
- To chose appropriate therapy strategies based on measurement based care（MBC）, providing hierarchical model diagnostic technique for patients.
- To weigh therapy efficiency and adverse effect among different medicine therapy groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
patients with depressive disorder were randomly assigned to different therapy groups or TAU therapy group based on different depressive disorders subtypes.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
Depression/underload 3
This group would be treated with fluoxetine and amfebutamone from the minimum dosage.
干预措施: fluoxetine + Amfebutamone (Drug)
Depression/underload 1
This group would be treated with fluoxetine from the minimum dosage.
干预措施: Fluoxetine (Drug)
Depression/underload 2
This group would be treated with fluoxetine combined with cognitive behavior treatment
干预措施: fluoxetine + cognitive-behavioral treatment（CBT） (Combination Product)
Depression/underload 4
This group would be treated with fluoxetine + physical treatment to help to cure depressive disorder.
干预措施: physical treatment+fluoxetine+amfebutamone (Combination Product)
Atypical 1
This group would be treated with fluvoxamine from the minimum dosage.
干预措施: Fluvoxamine (Drug)
Atypical 2
This group would be treated with fluoxetine + cognitive behavior treatment
干预措施: Cognitive behavior treatment +fluvoxamine (Combination Product)
Atypical 3
This group would be treated with fluvoxamine + lithium from the minimum dosage.
干预措施: Lithium+fluvoxamine (Drug)
Atypical 4
This group would be treated with fluvoxamine + lithium + physical treatment
干预措施: fluvoxamine + lithium + physical therapy (Combination Product)
Anxiety/somatization 1
This group would be treated with mirtazapine/selective serotonin-norepinephrine reuptake inhibitors（SNRIs） from the minimum dosage.
干预措施: Mirtazapine/SNRIs (Drug)
Anxiety/somatization 2
This group would be treated with mirtazapine/SNRIs + cognitive behavior treatment.
干预措施: mirtazapine+ Cognitive behavior treatment (Combination Product)
Anxiety/somatization 3
This group would be treated with mirtazapine + SNRIs from the minimum dosage.
干预措施: mirtazapine + SNRIs (Drug)
Anxiety/somatization 4
This group would be treated with mirtazapine + SNRIs + physical treatment.
干预措施: mirtazapine + SNRIs + physical therapy (Combination Product)
treatment as usual(TAU)
The investigators recommend therapy strategies according to accessible methods.
干预措施: TAU(treat as usual) (Other)
结局指标
主要结局
Change from baseline in levels of microRNA，apolipoproteins, meta ion (Composite measure)
时间窗: 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.
次要结局
- the gray matter volume,(change from baseline neuroimaging data at 2,4,6,8,12 week)
- Neuroelectrophysiological examination: electroencephalogram(EEG)(at baseline)
- life event scale(LES)(at baseline)
- dysfunctional attitudes scales(DAS)(at baseline)
- Hamilton Depression Scale(HADA) scores,reductive ratio(at 0,2,4,6,8,12 week.)
- Patient health questionnaire(PHQ-9):the clinical remission ratio(change from baseline PHQ-9 total scores at 2,4,6,8,12 week)
- social support scale(SSS)(at baseline)
- Neuroelectrophysiological examination:electrocardiograph(ECG)(at baseline.)
- fractional amplitudes of low-frequency fluctuation(fLAFF)(change from baseline neuroimaging data at 2,4,6,8,12 week)