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The patients with depression were observed and followed up to evaluate the changes of symptoms and cognitive function in patients with depression at different time points before and after drug treatment. At the same time, immunometabolism indicators in serum, urine and stool were detected to screen out immunoinflammatory markers related to cognitive function and treatment response in patients with depression, hoping to provide a new strategy for optimal treatment of depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MD group | Patients with depression who met the inclusion criteria |
| |
| HC group | Healthy subjects meeting enrollment criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no-intervention | Other | no-intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Scores of Hamilton Depression Scale | Using to assess depressive symptoms. With higher scores associated with more severe depression symptoms. Total scores <7 is normal; Mild depression with total scores of 7~17; Moderate depression with total scores of 18~24; Total scores >24 for severe depression. | baseline、2weeks、8weeks、12weeks、24weeks |
| Scores of Hamilton Anxiety Scale | Using to assess anxiety symptoms. With higher scores associated with more severe anxiety symptoms. Total scores< 7 indicates no anxiety; Total scores≥7 indicates possible anxiety; Total scores≥14 indicates anxiety; Total scores≥21 indicates obvious anxiety; Total scores≥29 points indicates serious anxiety. | baseline、2weeks、8weeks、12weeks、24weeks |
| Patient Health Questionnaire-9 | Using to assess depression symptoms, scores range from 0~27, With higher scores associated with more severe depression symptoms. Total scores 0~4 indicates no depression; Total scores 5~9 indicates mild depression; Total scores 10~14 indicates moderate depression; Total scores 15~19 indicate moderate to severe depression; Total scores 20~27 indicates major depression. | baseline、2weeks、8weeks、12weeks、24weeks |
| Generalized self-rating anxiety Scale | Using to assess anxiety symptoms, scores range from 0~21. With higher scores associated with more severe anxiety symptoms. Total scores 5~9 indicates mild anxiety; Total scores 10~14 scores indicate moderate anxiety; Total scores 15~21 scores indicate severe anxiety. | baseline、2weeks、8weeks、12weeks、24weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Thinc-it cognitive function test | The THINC-it tool is digitalized and completed by the respondent on a tablet is used to assess cognitive function in patients with MDD. Includes four objective test, Spotter (Choice Reactio Time), Symbol Check (1-back test), Trails (Trails Making Test B), and Codebreaker (Digit Symbol Substitution Test) as well as a self-reported cognitive function questionnaire (i.e., Perceived Deficit Questionnaire, 5-item). |
| Measure | Description | Time Frame |
|---|---|---|
| Serum metabolites | Metabolites in serum were quantified using LC-MS/MS. LC-MS/MS analyses were performed using a UHPLC system. | baseline、2weeks、8weeks、12weeks、24weeks |
| Shotgun Metagenomic Sequencing and Metagenome-Wide Intestinal macrogene |
Inclusion Criteria:
Exclusion Criteria:
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Meet the diagnostic criteria for depression in the International Classification of Diseases-10 (ICD-10), and the Hamilton Depression Scale (HAMD) score ≥18 points
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia M | Contact | 02985324575 | tsooung@163.com | |
| Ma q y | Contact | 02985324575 | mqy910413@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ma x c | First Affiliated Hospital Xi'an Jiaotong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 277 Yanta West Road | Recruiting | Xi'an | Yanta | 710061 | China |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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serum
| basline、12weeks、24weeks |
| Sheehan Disability Scale | It was used to evaluate the impairment of social function in three areas of work/school, social life and family life of patients with depression. 0~10 scores were used in each area, and the total score was 0~30 points. The higher the score, the more serious the impairment of function. | basline、12weeks、24weeks |
| Pittsburgh Sleep Quality Index | Using to assess the sleep quality. Total scores of 0-5 indicates that the quality of sleep is very good, 6~10 indicates that the quality of sleep is OK, 11~15 indicates that the quality of sleep is average, and 16~21 indicates that the quality of sleep is poor. | baseline、2weeks、8weeks、12weeks、24weeks |
| Gastrointestinal function scale | A rating scale for gastrointestinal symptoms in patients. It contains 16 items, total scores 16~112, each items is graded on a scale of 1~7, the higher total scores, the more severe the gastrointestinal symptoms. | baseline、2weeks、8weeks、12weeks、24weeks |
Shotgun metagenomic sequencing and alignment methods were used to detect fecal flora diversity
| baseline、2weeks、8weeks、12weeks、24weeks |