Longitudinal study on bipolar disorder and major depressive disorder

Chinese Longitudinal and Systematic Study of Bioplar Disorder

This study is trying to find new biological markers that can help doctors diagnose and treat people with bipolar disorder and major depressive disorder by looking at how gut health and brain function are connected.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10000 (estimated)
• Ages: 16 Years to 65 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05480150 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are Han nationality individuals aged 16-65 who meet the DSM-5 criteria for depressive episodes of major depressive disorder or bipolar disorder.

Not a fit: Patients with schizophrenia, neurodevelopmental disorders, or those with serious physical illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate diagnoses and personalized treatment options for patients with affective disorders.

How similar studies have performed: While studies exploring the gut-brain axis are emerging, this specific approach to identifying biomarkers in affective disorders is relatively novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Hangzhou, Zhejiang

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

Study contacts

• Study coordinator: Shaohua Hu

Conditions: Major Depressive Disorder, Bipolar Disorder, Mixed, Affective, Disorder, Organic, Bipolar Disorder, Affective Disorder, Gut-Brain Axis