Chinese Longitudinal and Systematic Study of Bioplar Disorder

NCT05480150 | Recruiting DMC

• 1 other identifier: IIT20210291B-R1
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Major Depressive Disorder; Bipolar Disorder; Affective Disorder; Gut-Brain Axis

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale(MADRS)

  MADRS score is to evaluate the degree of depression, and the higher score means severer depression.

  0 ~16 weeks

Study Arms (3)

bipolar disorder

EXPERIMENTAL

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

Drug: Quetiapine Fumarate Tablets; Drug: Lurasidone

major depressive disorder

EXPERIMENTAL

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

Drug: Escitalopram Oxalate Tablets

healthy control

NO INTERVENTION

no interventions

Interventions

Escitalopram Oxalate Tablets DRUG

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

Also known as: Lexapro

major depressive disorder

Quetiapine Fumarate Tablets DRUG

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

Also known as: Seroquel

bipolar disorder

Lurasidone DRUG

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

Also known as: Latuda

bipolar disorder

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.;
• Had received medication (such as antidepressants, antipsychotics, mood stabilizers, etc.) within 1 month before enrollment;
• 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;

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 41088296 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Mood Disorders

Interventions

Escitalopram; Quetiapine Fumarate; Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mental Disorders; Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Isoindoles

Central Study Contacts

Shaohua Hu

CONTACT

086-13957162903; dorhushaohua@zju.edu.cn

Yanmeng Pan

CONTACT

18868116237; 12018602@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Psychaitry , First Affiliated Hospital of Zhejiang University

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: July 29, 2022
• Study Start: November 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)