Chinese Longitudinal and Systematic Study of Bioplar Disorder

NCT ID: NCT05480150

Last Updated: 2022-10-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2026-12-31

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.

Detailed Description

Mental health is a major public health problem affecting the whole social and economic development. According to a 2019 report in The Lancet Psychiatry, the weighted lifetime prevalence of mental disorders (excluding dementia) in China is 16.6%, with the lifetime prevalence of emotional disorders as high as 7.4%.Affective disorders (mainly including depression and bipolar disorder) are common, chronic and highly disabling mental disorders.Back in 2008, the World Health Organization listed MDD（Major Depressive Disorder） as one of the three major contributors to the overall global burden of disease. It is expected that by 2030, the number of MDD patients will exceed the total number of cardiovascular disease patients combined and become the leading cause of disability in the world.

At present, the diagnostic criteria of mental disorders, including DSM-5 and ICD-11, still mainly rely on the evaluation of symptoms, lacking objective and intuitive biomarkers. Therefore psychiatrists are prone to disagreement in diagnosis and treatment of diseases, which is a realistic bottleneck hindering the development of psychiatry. The differential diagnosis of MDD and BD depressive episodes is an unavoidable clinical challenge, which often leads to misdiagnosis and affects the treatment and prognosis of the disease. Therefore, it is one of the important directions for the development of brain science to strengthen scientific research in the field of mental health, especially to explore the mechanism of disease occurrence and development, develop objective new auxiliary diagnostic technologies and innovate precise treatment strategies around major emotional disorders. 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. This study based on brain - im axis, intends to create an emotional disorder large queue, through the study of gut microbes (diversity and abundance of species), serum metabolites, and immune index, brain outside source sex secretion, brain imaging and other key indicators, select high efficiency and convenient for clinical diagnosis and curative effect of prediction of biomarkers.

Conditions

Major Depressive Disorder; Bipolar Disorder, Mixed; Affective; Disorder, Organic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bipolar disorder

Patients with BD depressive episode received standard treatment with quetiapine fumarate tablets, starting from 50mg/ night, titrated to a therapeutic dose of 300-400mg/ night within 10 days, and maintained treatment for 4 weeks. According to the patient's condition, patients with BD depressive episode could receive another standard treatment with lurasidone, starting from 20mg/ night, titrated to a therapeutic dose of 40mg/ night within 6 days, and maintained treatment for 4 weeks. Adverse reactions and changes in condition of all patients were recorded

Group Type: EXPERIMENTAL

Quetiapine Fumarate Tablets

Intervention Type: DRUG

Starting at 50mg qn, the treatment dose was titrated to 300-400mg qn within 10 days, and maintained the treatment for 4 weeks.

Lurasidone

Intervention Type: DRUG

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

major depressive disorder

MDD depressive episode patients received standard treatment with escitalopram oxalate tablets, starting from 5mg/ day once, titrated to a therapeutic dose of 10-20mg/ day within 1 week, and maintained treatment for 4 weeks

Group Type: EXPERIMENTAL

Escitalopram Oxalate Tablets

Intervention Type: DRUG

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

healthy control

no interventions

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Escitalopram Oxalate Tablets

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

Intervention Type: DRUG

Quetiapine 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.

Intervention Type: DRUG

Lurasidone

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

Intervention Type: DRUG

Other Intervention Names

Lexapro; Seroquel; Latuda

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Hu ShaoHua

Head of Department of Psychaitry , First Affiliated Hospital of Zhejiang University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shaohua Hu

Role: CONTACT

dorhushaohua@zju.edu.cn

086-13957162903

Yanmeng Pan

Role: CONTACT

12018602@zju.edu.cn

18868116237

Facility Contacts

Hu ShaoHua

Role: primary

dorhushaohua@zju.edu.cn

13957162903

References

Tang A, Chen Y, Ding J, Li Z, Xu C, Hu S, Lai J. Gut microbiota remodeling and sensory-emotional functional disruption in adolescents with bipolar depression. J Transl Med. 2025 Oct 14;23(1):1083. doi: 10.1186/s12967-025-07152-4.

Reference Type: DERIVED

PMID: 41088296 (View on PubMed)

Other Identifiers

IIT20210291B-R1

Identifier Type: -

Identifier Source: org_study_id