Model-based Defining of Subtypes of Depression and Optimal Treatment: an Integrated Techniques Module in Multidimensional Omics for Peripheral Biomarkers.

Study Overview
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Brief Summary
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In this proposal, the investigators aim to explore the clinical subtypes and biological markers to personalize the use antidepressants in MDD. By stratifying the subjects with (versus without) remission and treatment response, the biological markers are expected to have important prediction effects in future clinical practice.

Official Title
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Model-based Defining of Subtypes of Depression and Optimal Treatment: an Integrated Techniques Module in Multidimensional Omics for Peripheral Biomarkers.

Conditions
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Major Depressive Disorder

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects aged 18-65 years, outpatients or inpatients. Meets the DSM-V criteria for Severe Major Depressive Disorder ; a single episode（296.21、296.22、296.23）or recurrent episode （296.31、296.32、296.33）； MADRS score greater than or equal to 24 in baseline； HAMD-17 score greater than or equal to 20 in baseline. Patients have learned and voluntarily participated in the study, and have to sign informed consent. Exclusion Criteria: Meets the DSM-V criteria for other mental disorder(schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, anxiety disorders, obsessive-compulsive and related disorders, somatic symptom and related disorders, etc ). Patient has survived suicide attempt , or may have a significant risk for suicidal behavior ,or with a score of >3 on suicidal thoughts item 10 on the MADRS. Depressive episode of an organic mental disorder secondary to a systemic disease or a central nervous system disease, such as depressive episode secondary to hypothyroidism. Serious and instable body disease such as cerebrovascular disease, respiratory disease, blood disease, liver and kidney disease, disease of internal secretion, nervous system and other systemic disease. any history of seizures or other organic brain diseases. History of alcohol or drug abuse (besides nicotine) over the last 6 months Serious and instable body disease such as cerebrovascular disease, liver and kidney disease, disease of internal secretion (abnormal thyroid function), blood disease; any history of seizures or other organic brain diseases. Subjects who can't take drug or have an operation history which affect drug metabolism. Clinically significant changes in ECG or laboratory tests, including >1.5X upper limit of normal liver function、over the limit of normal renal function and blood sugar、abnormal cardiac troponins、obvious abnormity in the thyroid function Pregnant or lactating women and women of childbearing potential throughout the study period; men who have the desire of fertility within three months; Participation in other clinical studies in the nearly 1 month before screen. Other conditions which, in the investigator's judgment, render patients unsuitable for the clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Severe Major Depressive Disorder<br> | |
| control , healthy<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reductive ratio of HAMD-17 |  | assess the scale at baseline and week 4, 8. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Asberg Depression Rating Scale (MADRS). |  | assess the scale at baseline and week 4, 8. | 
| HAMILTON ANXIETY SCALE (HAMA) |  | assess the scale at baseline and week 4, 8. | 
| Clinical Global Impression scale - Severity of Illness (CGI-S) |  | assess the scale at baseline and week 4, 8. | 
| The Pittsburgh Sleep Quality Index (PSQI) |  | assess the scale at baseline and week 4, 8. | 
| The Montreal Cognitive Assessment (MoCA), score |  | assess the scale at baseline and week 4, 8. | 
| The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) (QIDS-SR16) |  | assess the scale at baseline and week 4, 8. |