Chinese Longitudinal and Systematic Study of Bioplar Disorder

Recruiting now · Not applicable

Conditions studied: Major Depressive Disorder, Bipolar Disorder, Mixed, Affective; Disorder, Organic

In brief

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.

Key facts

Study ID

NCT05480150

Run by

First Affiliated Hospital of Zhejiang University

People needed

10000

Starts

2021-11-01

Expected to finish

2026-12-31

Last updated by the study team

2022-10-17

Who can join

Age: 16 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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

• The First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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