Chinese Longitudinal and Systematic Study of Bioplar Disorder

Condition(s) studied

Investigational drug(s) / intervention(s)

Escitalopram Oxalate Tablets: Starting at 5mg qn, the treatment dose was titrated to 10-20mg qn within 1 week and maintained for 4 weeks

Quetiapine Fumarate Tablets: Starting at 50mg qn, the treatment dose was titrated to 300-400mg qn within 10 days, and maintained the treatment for 4 weeks.

Lurasidone: Starting at 20mg qn, the treatment dose was titrated to 40mg qn within 6 days,and maintained the treatment for 4 weeks.

Study 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.

Eligibility

Primary outcome measure(s)

• Montgomery-Asberg Depression Rating Scale(MADRS) — 0 ~16 weeks
  MADRS score is to evaluate the degree of depression, and the higher score means severer depression.

Trial sites (1)

More First Affiliated Hospital of Zhejiang University trials in China

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