NCT05480150Recruiting
Chinese Longitudinal and Systematic Study of Bioplar Disorder
Source: ClinicalTrials.gov · Last updated 17 Oct 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10000 (estimated)
- First submitted
- 28 Jul 2022
- Start date
- 1 Nov 2021
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Diseases
- Depression, Bipolar disorder
- NCT number
- NCT05480150
What you commit to
- Study type: Interventional
- Planned participants: 10000
- From 1 Nov 2021 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had received medication (such as antidepressants, antipsychotics, mood stabilizers, etc.) within 1 month before enrollment;
Other illness
- 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.;
- Other conditions that the researcher considers inappropriate for inclusion.
Other
- 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;
Who the study is looking for
- 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;
Age in the registry: 16 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.