Multi-Dimensional Diagnosis,Individualized Therapy,and Management Technique for Major Depressive Disorder:Based on Clinical and Pathological Characteristics (STEP-MDD)

Shanghai Mental Health Center

Status and phase: Unknown; Phase 4

Conditions: Depressive Disorder

Treatments: Combination Product: mirtazapine + SNRIs + physical therapy; Combination Product: fluoxetine + cognitive-behavioral treatment（CBT）; Drug: Mirtazapine/SNRIs; Drug: Fluoxetine; Combination Product: mirtazapine+ Cognitive behavior treatment; Other: TAU(treat as usual); Combination Product: physical treatment+fluoxetine+amfebutamone; Drug: Lithium+fluvoxamine; Drug: Fluvoxamine; Combination Product: Cognitive behavior treatment +fluvoxamine; Drug: fluoxetine + Amfebutamone; Drug: mirtazapine + SNRIs; Combination Product: fluvoxamine + lithium + physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03219008

2016YFC1307100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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800 participants in 13 patient groups

Depression/underload 1

Experimental group

Description:

This group would be treated with fluoxetine from the minimum dosage.

Treatment:

Drug: Fluoxetine

Depression/underload 2

Experimental group

Description:

This group would be treated with fluoxetine combined with cognitive behavior treatment

Treatment:

Combination Product: fluoxetine + cognitive-behavioral treatment（CBT）

Depression/underload 3

Experimental group

Description:

This group would be treated with fluoxetine and amfebutamone from the minimum dosage.

Treatment:

Drug: fluoxetine + Amfebutamone

Depression/underload 4

Experimental group

Description:

This group would be treated with fluoxetine + physical treatment to help to cure depressive disorder.

Treatment:

Combination Product: physical treatment+fluoxetine+amfebutamone

Atypical 1

Experimental group

Description:

This group would be treated with fluvoxamine from the minimum dosage.

Treatment:

Drug: Fluvoxamine

Atypical 2

Experimental group

Description:

This group would be treated with fluoxetine + cognitive behavior treatment

Treatment:

Combination Product: Cognitive behavior treatment +fluvoxamine

Atypical 3

Experimental group

Description:

This group would be treated with fluvoxamine + lithium from the minimum dosage.

Treatment:

Drug: Lithium+fluvoxamine

Atypical 4

Experimental group

Description:

This group would be treated with fluvoxamine + lithium + physical treatment

Treatment:

Combination Product: fluvoxamine + lithium + physical therapy

Anxiety/somatization 1

Experimental group

Description:

This group would be treated with mirtazapine/selective serotonin-norepinephrine reuptake inhibitors（SNRIs） from the minimum dosage.

Treatment:

Drug: Mirtazapine/SNRIs

Anxiety/somatization 2

Experimental group

Description:

This group would be treated with mirtazapine/SNRIs + cognitive behavior treatment.

Treatment:

Combination Product: mirtazapine+ Cognitive behavior treatment

Anxiety/somatization 3

Experimental group

Description:

This group would be treated with mirtazapine + SNRIs from the minimum dosage.

Treatment:

Drug: mirtazapine + SNRIs

Anxiety/somatization 4

Experimental group

Description:

This group would be treated with mirtazapine + SNRIs + physical treatment.

Treatment:

Combination Product: mirtazapine + SNRIs + physical therapy

treatment as usual(TAU)

Experimental group

Description:

The investigators recommend therapy strategies according to accessible methods.

Treatment:

Other: TAU(treat as usual)