Bipolar Disorder
Conditions
Interventions
Gold Standard:ICD-10 diagnostic criteria for bipolar depressive episode and recurrent depressive disorder, confirmed by psychiatrists through clinical symptoms and scale assessments.
Index test:1.16S rRNA sequencing (gut microbiota analysis)
2.Clinical scales (HAMD-17, BRMS, HCL-32)
3.Blood biochemical markers (plasma uric acid, thyroid function, lipids, inflammatory cytokines, etc.)
Sponsors
Zhoushan second people's Hospital
Eligibility
Sex/Gender
All
Age
15 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1.Meet ICD-10 criteria for bipolar depressive episode/depressive disorder; 2.Age 15-50 years, gender ,education >= 6 years; 3.HAMD-17 >17; 4.No systematic psychotropic medication in the past month; 5.Informed consent signed. 6.>= 2 major depressive episodes;
Exclusion criteria
Exclusion criteria: 1.Comorbid severe systemic diseases (e.g., cardiovascular/hepatic failure, cancer); 2.Participation in other clinical trials or behavioral interventions; 3.Other conditions deemed unsuitable by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bech-Rafaelsen Mania Scale (BRMS) score;Hamilton Depression Scale-17 item (HAMD-17) score;Accuracy;Sensitivity;Specificity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Relative abundance of gut microbiota (e.g., Firmicutes, Bacteroidetes, Faecalibacterium, Ruminococcus);Blood lipids (triglycerides, cholesterol, LDL, VLDL);Differential microbial biomarkers (e.g., OTUs in Lachnospiraceae, Prevotellaceae);Inflammatory cytokines (e.g., IL-6, TNF-a, sTNFR1, sTNFR2);Thyroid function (T3, free triiodothyronine);Homocysteine level;32-item Hypomania Checklist (HCL-32) score;Plasma uric acid (UA) level;Gut microbiota diversity (a-diversity, ß-diversity); | — |
Countries
China
Contacts
Public ContactYongfa Wu
Zhoushan second people's Hospital
Outcome results
None listed