Longitudinal study on bipolar disorder and major depressive disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to establish a large cohort of patients with affective disorders, specifically major depressive disorder and bipolar disorder, to identify efficient biomarkers for clinical diagnosis and treatment efficacy prediction. It will explore the relationship between gut microbes, serum metabolites, immune indexes, and brain function through advanced imaging techniques. By focusing on the brain-gut axis, the research seeks to provide objective biological markers that can improve diagnostic accuracy and treatment outcomes for these common mental health conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Both biological parents are Han nationality;
2. Aged 16-65;
3. The subjects met the clinical diagnostic criteria of DSM-5 for depressive episodes of MDD/BD;
4. Did not take any immunomodulatory preparations within 1 month before enrollment;
5. No clear history of respiratory tract, urinary system, digestive system infection within 1 month before enrollment;

Exclusion Criteria:

1. Those with schizophrenia spectrum, neurodevelopmental disorder, dementia, memory impairment or other cognitive impairment that meet the DIAGNOSTIC criteria of DSM-5;
2. 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.;
3. Had received medication (such as antidepressants, antipsychotics, mood stabilizers, etc.) within 1 month before enrollment;
4. those who had used ECT before enrollment;
5. Currently have serious suicidal thoughts or behaviors, or serious excitement;
6. those who cannot follow the doctor's advice or have no guardian;
7. pregnant or breast-feeding women, or those who plan to become pregnant;
8. Contraindications to MRI examination;
9. Other conditions that the researcher considers inappropriate for inclusion.

Where it's running

• The First Affiliated Hospital of Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Shaohua Hu
• Email: dorhushaohua@zju.edu.cn
• Phone: 086-13957162903

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.