drugset / Trial / NCT05480150

Chinese Longitudinal and Systematic Study of Bioplar Disorder

NCT05480150

Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2021-11-01
Primary completion
2026-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Escitalopram Small molecule 10 mg
Subject Escitalopram Small molecule 20 mg
Subject Lurasidone Small molecule 40 mg
Subject Quetiapine Small molecule 300 mg
Subject Quetiapine Small molecule 400 mg