Bipolar Disorder (BPD) Clinical Trials

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Chinese Longitudinal and Systematic Study of Bioplar Disorder

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 65
Healthy Volunteers: t
View:

• 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;

Locations
Other Locations
China
The First Affiliated Hospital of Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Shaohua Hu
dorhushaohua@zju.edu.cn
086-13957162903
Backup
Yanmeng Pan
12018602@zju.edu.cn
18868116237
Time Frame
Start Date: 2021-11-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 10000
Treatments
Experimental: 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
Experimental: 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
No_intervention: healthy control
no interventions
Related Therapeutic Areas
Sponsors
Leads: First Affiliated Hospital of Zhejiang University

This content was sourced from clinicaltrials.gov