Chinese Longitudinal and Systematic Study of Bioplar Disorder
Recruiting · NCT05480150 · Interventional (participants receive a specific treatment) · Lead sponsor: First Affiliated Hospital of Zhejiang University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Affective disorders (mainly including major depressive disorder and bipolar disorder) are common, chronic and highly disabling mental disorders, which lack of objective biological markers. It is believed that genetic and environmental factors are involved in the development of affective disorders. Gut microbes can affect the function of brain neural circuits by mediating metabolic, immune, endocrine and autonomic changes along the brain-gut axis. The brain can also regulate intestinal microbes through endocrine, neural structure, neurogenic exosomes and other pathways. Based on the brain-gut axis, this study intends to establish a large cohort of affective disorders, and screen out efficient and convenient biomarkers for clinical diagnosis and efficacy prediction by studying key indicators such as intestinal microbes, serum metabolites and immune indexes, brain-derived exosomes, and brain functional imaging.
Who can take part
Inclusion criteria
- Both biological parents are Han nationality;
- Aged 16-65;
- The subjects met the clinical diagnostic criteria of DSM-5 for depressive episodes of MDD/BD;
- Did not take any immunomodulatory preparations within 1 month before enrollment;
- No clear history of respiratory tract, urinary system, digestive system infection within 1 month before enrollment;
Exclusion criteria
- Those with schizophrenia spectrum, neurodevelopmental disorder, dementia, memory impairment or other cognitive impairment that meet the DIAGNOSTIC criteria of DSM-5;
- Mental disorders caused by substance abuse (alcohol, drugs, etc.), patients suffering from serious physical diseases and immune system diseases, such as diabetes, thyroid diseases, hypertension, heart disease, liver and kidney dysfunction, autoimmune diseases, etc.;
- Had received medication (such as antidepressants, antipsychotics, mood stabilizers, etc.) within 1 month before enrollment;
- those who had used ECT before enrollment;
- Currently have serious suicidal thoughts or behaviors, or serious excitement;
- those who cannot follow the doctor's advice or have no guardian;
- pregnant or breast-feeding women, or those who plan to become pregnant;
- Contraindications to MRI examination;
- Other conditions that the researcher considers inappropriate for inclusion.
Where it is running
1 location listed.
- The First Affiliated Hospital of Zhejiang University - Hangzhou, Zhejiang, China