Multi-factor Model Constraction for Early Warning and Diagnosis of MDD

Study Overview
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Brief Summary
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Current research on the pathogenesis of depression shows that imbalanced inflammatory factors are closely related to Major Depressive Disorder(MDD). As reported, physical exercise, Ω-3 fatty acids, and sulforaphane can be complementary therapies for moderate-to-severe depression. In addition, imaging studies have found changes in the structure and functional connectivity of the brain. Therefore, this study intends to collect clinical and biological information from patients with depression and healthy controls to establish a multi-factor model for early warning and diagnosis of major depressive disorder

Detailed Description
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The immune imbalance has been reported in patients with unipolar and bipolar depression. There is no unified conclusion in the field and severity of the immune imbalance, and the cause of cognitive impairment is unknown, which may be related to many factors. Omega-3 fatty acids are immune modulators that possess antidepressant effects. This study includes three steps. We will enroll bipolar and major depressive disorder patients who are in a depressive episode and enroll healthy controls. All subjects will be assessed at baseline We will give omega-fatty acid treatment based on immune indicators The follow-up will last for one year with five sessions.

Official Title
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Multi-factor Model Constraction for Early Warning and Diagnosis of Major Depressive Disorder

Conditions
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Major Depressive Disorder, Bipolar Disorder, Omega-3 Fatty Acids

Intervention / Treatment
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* Drug: Omega 3 fatty acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients in main-center and sub-centers Age between 18-65 years old Meet the DSM-IV diagnosis of depressive episode HAMD-17 score>17 at baseline No antidepressant treatment within 6 weeks prior to enrollment Adequate cognition level to complete the tests necessary for the study Willing to sign the informed consent form Exclusion Criteria: Have any contraindications to Ω-3 fatty acids Severe physical disease Diagnosed with schizophrenia, or other mental illness spectra Have received physical therapy

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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Major depressive disorder<br>Outpatients in main-center and sub-centers; meet the DSM-IV diagnosis of Major Depressive Disorder (mental examination was conducted by at least two professional doctors); available relevant HIS system biochemical data; haven't been treated with physical therapy; age between 18-65 years old; gender is not limited. | Drug: Omega 3 fatty acid<br>* Omega-3 fatty acids complementation according to the patient's CRP level<br>* Other names: Ω-3 fatty acids;|
| Active Comparator: Bipolar disorder<br>Outpatients in main-center and sub-centers; meet the DSM-IV diagnosis of Bipolar disorder (mental examination was conducted by at least two professional doctors); available relevant HIS system biochemical data; haven't been treated with physical therapy; age between 18-65 years old; gender is not limited | Drug: Omega 3 fatty acid<br>* Omega-3 fatty acids complementation according to the patient's CRP level<br>* Other names: Ω-3 fatty acids;|
| No Intervention: Healthy controls<br>Healthy controls in main-center and sub-centers; no history of psychiatric disease; age between 18-65 years old; gender is not limited. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms assessed by HAMD-17 | Depressive symptoms are the primary outcome, and we will use HAMD-17 to examine depressive symptoms. Respones: a reduction of 50% or more in baseline scores.Remission:HAMD⩽7. | up to 12 months |