Major Depressive Disorder(MDD)
Conditions
Interventions
Observation group (Depression group) :None
Control group (Healthy control group):None
Sponsors
The First Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Observation Group (all 7 criteria must be met simultaneously) (1)Age: Outpatients or inpatients aged 12 years or older, with no restriction on gender. (2)Diagnosed with depression in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), including first-onset and recurrent cases. (3)The score of the 17-item Hamilton Depression Rating Scale (HAMD-17) was >= 14 at the screening and baseline visits. (4)Sufficient sample volume: Remaining serum/plasma/whole blood >=500 µL; remaining stool sample >= 0.5 g, to meet the requirements for subsequent testing. (5)Complete sample information, including basic clinical data (e.g., age, gender, primary diagnosis, use of antidepressants, etc.). (6)Qualified sample quality: No severe hemolysis, lipemia, jaundice or contamination. 2.Healthy Control Group (all 4 criteria must be met simultaneously) (1)Age: Outpatients or inpatients aged 12 years or older, with no restriction on gender. (2)Generally healthy with no history of somatic diseases involving the cardiovascular, respiratory, digestive, renal, endocrine, hematological or other systems. (3)No prior history of mental disorders. (4)Routine clinical laboratory tests (e.g., blood routine, liver function, renal function, etc.) are within the normal reference ranges, or deemed to have no clinically significant abnormalities by the investigators.
Exclusion criteria
Exclusion criteria: 1.Exclusion Criteria for Observation Group (Any of the following items will lead to exclusion) (1)Current or prior diagnosis of major mental disorders other than depressive disorder, including neurodevelopmental disorders, neurocognitive disorders, schizophrenia and other psychotic disorders, bipolar affective disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, alcohol or drug dependence/abuse, personality disorders, etc. (2)Depressive episodes secondary to organic mental disorders caused by systemic diseases or neurological diseases (e.g., depression induced by hypothyroidism). (3)Presence of severe or unstable diseases of the cardiovascular, respiratory, hepatic, renal, endocrine, hematological or other systems, who are considered ineligible for enrollment by the investigators. (4)Abnormal physical examination or laboratory test findings with obvious clinical significance as judged by the investigators at the screening or baseline visit. (5)Received modified electric convulsive therapy (MECT), transcranial magnetic stimulation (TMS), deep brain stimulation (DBS) or vagus nerve stimulation (VNS) within 3 months prior to screening. (6)Pregnant or lactating females; females of childbearing potential with positive serum or urine human chorionic gonadotropin (HCG) test at screening; males with reproductive potential or females of childbearing potential who are unable to use effective contraception throughout the study; or those who plan to conceive or father a child within 3 months after study initiation. (7)Participation in any interventional clinical trial within 3 months prior to screening. (8)Any other conditions that may interfere with the evaluation of study outcomes, as determined by the investigators. 2.Exclusion Criteria for Healthy Control Group(Subjects meeting any of the following items shall be excluded) (1)Currently suffering from any mental disorder. (2)History of consciousness disturbance, schizophrenia, bipolar affective disorder, depressive disorder, personality change or other psychiatric diseases. (3)History of hereditary familial diseases. (4)Presence of severe somatic diseases, including endocrine diseases, cardiovascular and cerebrovascular diseases, etc. (5)History of alcohol or drug dependence. (6)Pregnant or lactating females. (7)Blood samples with severe hemolysis, lipemia, improper storage or other defects that fail to meet sample quality requirements. (8)Any other conditions deemed by the investigators to potentially interfere with the evaluation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMD-17 Depression Severity Score;Depression status; | — |
Secondary
| Measure | Time frame |
|---|---|
| Metabolic indicators (blood lipids);Immune and inflammatory indicators;Neuroendocrine indicators (HPA axis and sex hormones);Gut microbiome indicators; | — |
Countries
China
Contacts
Public ContactPan Junxi
The First Affiliated Hospital of Kunming Medical University
Outcome results
None listed