NCT05480150 Chinese Longitudinal and Systematic Study of Bioplar Disorder
| NCT ID | NCT05480150 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2021-11-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10,000 participants in total. It began in 2021-11-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05480150 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 65 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05480150 currently recruiting?
Yes, NCT05480150 is actively recruiting participants. Contact the research team at dorhushaohua@zju.edu.cn for enrollment information.
Where is the NCT05480150 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05480150 clinical trial?
NCT05480150 is sponsored by First Affiliated Hospital of Zhejiang University. The trial plans to enroll 10,000 participants.