RecruitingNot ApplicableNCT05480150

Chinese Longitudinal and Systematic Study of Bioplar Disorder


Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

10,000 participants

Start Date

Nov 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 16 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at the biology behind depression and bipolar disorder — specifically how the immune system and brain may be connected in people experiencing these conditions. You may be eligible if: - You are between 16 and 65 years old - Both of your biological parents are of Han Chinese heritage - You have been diagnosed with a depressive episode related to major depression or bipolar disorder - You have not taken any immune-modifying medicines in the past month - You have not had a respiratory, urinary, or digestive infection in the past month You may NOT be eligible if: - You have been diagnosed with schizophrenia, a developmental disorder, dementia, or significant memory or thinking problems - You have a mental health condition caused by substance use (like alcohol or drugs) - You have a serious physical illness such as uncontrolled diabetes, thyroid disease, heart disease, liver or kidney problems, or an autoimmune disease - You have taken antidepressants, antipsychotics, or mood stabilizers in the past month - You have had electroconvulsive therapy (ECT) before - You are currently having serious thoughts of suicide or are in a mental health crisis - You are pregnant, breastfeeding, or planning to become pregnant - You have reasons that make MRI scans unsafe for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEscitalopram Oxalate Tablets

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

DRUGQuetiapine 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.

DRUGLurasidone

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


Locations(1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

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NCT05480150


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