Major Depressive Disorder Clinical Trial
Official title:
Multi-factor Model Constraction for Early Warning and Diagnosis of Major Depressive Disorder
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
Status | Recruiting |
Enrollment | 600 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 O-3 fatty acids - Severe physical disease - Diagnosed with schizophrenia, or other mental illness spectra - Have received physical therapy |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Mental Health Center IRB | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Mental Health Center | Harbin Medical University, Qingdao Mental Health Center |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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