NCT03219008

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

Multi-dimensional Diagnosis,Individualized Therapy,and Management Technique for Major Depressive Disorder:Based on Clinical and Pathological Characteristics

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depressive Disorder

Interventions

Type	Name	Description
DRUG	Fluoxetine	Fluoxetine is one kind of selective serotonin reuptake inhibitor(SSRIs), whose effect is much better than other non-underload subtypes compared with underload subtypes.So patients would be treated with fluoxetine only.
COMBINATION_PRODUCT	fluoxetine + cognitive-behavioral treatment（CBT）	the investigators would recommend fluoxetine to help to cure depressive disorder.And CBT is a very effective way for patients to alleviate or relieve clinical symptoms during episode stage.
DRUG	fluoxetine + Amfebutamone	Amfebutamone is one kind of SNRIs, and it shows much better therapy effect on patients with exhaustion /dizziness.So the investigators recommend these two drugs to help to cure patients with depressive disorder.
COMBINATION_PRODUCT	physical treatment+fluoxetine+amfebutamone	the investigators recommend drug(fluoxetine and amfebutamone) and physical treatment as intervention.
DRUG	Fluvoxamine	Fluvoxamine could inhibit CYP1A2 and CYP2C19 and affect the metabolism of melatonin, and help to release symptoms of depressive disorder with sleep problems.
DRUG	Lithium+fluvoxamine	the investigators recommend lithium as a mood stabilizer and use fluvoxamine to affect the level of melatonin.
COMBINATION_PRODUCT	fluvoxamine + lithium + physical therapy	the investigators recommend depressants and mood stabilizers as well as physical therapy to help to cure depressive disorder.
COMBINATION_PRODUCT	Cognitive behavior treatment +fluvoxamine	the investigators recommend behavioral therapy as well as drugs.
DRUG	Mirtazapine/SNRIs	Mirtazapine is one kind of antagonist of a2 adrenergic receptors and could block 5-hydroxytryptamine2 and 5-hydroxytryptamine3,help to release symptoms like anxiety or somatization.Besides, SNRIs could also make similar effect on patients.Therefore, the investigators recommend mirtazapine/SNRIs to treat patients with depressive disorder.
COMBINATION_PRODUCT	mirtazapine+ Cognitive behavior treatment	the investigators recommend CBT and mirtazapine as interventions.The dosage and frequency would depend on patients' severity of symptoms .
DRUG	mirtazapine + SNRIs	the investigator recommend mirtazapine and SNRIs to treat patients with major depressive disorder.
COMBINATION_PRODUCT	mirtazapine + SNRIs + physical therapy	the investigators would manage to use drugs and physical treatment to help to release the symptoms of depressive disorder.
OTHER	TAU(treat as usual)	patients in this group would receive therapy strategies according to their symptoms and preference.

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-12-01
• Completion: 2020-12-01
• First posted: 2017-07-17
• Last updated: 2017-10-10

Locations

1 site across 1 country: China