Bipolar I Disorder Manic Episode
Conditions
Interventions
Experimental group (Qing Xin Wen Dan Tang combined with Western medicine group):Magnesium valproate sustained-release tablets (starting dose 500 mg/day) + Olanzapine (starting dose 5 mg/day) + Qingxin
Control group (Western medicine only group):Magnesium valproate sustained-release tablets + Olanzapine, dosage and administration same as the experimental group's Western medicine portion.
Healthy Control Group:No intervention measures will be administered
only fecal sample collection will be conducted.
Sponsors
Hunan Second People's Hospital (Hunan Brain Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-60 years, gender; (2) Meet the diagnostic criteria for manic episode of Bipolar I Disorder according to DSM-V; (3) Meet the diagnostic criteria for phlegm-fire disturbing the mind syndrome in traditional Chinese medicine; (4) Young Mania Rating Scale (YMRS) score =20 points; (5) Normal results or no clinically significant abnormalities in laboratory tests (complete blood count, liver and kidney function, blood glucose, lipid profile, electrocardiogram); (6) Patients or legal representatives voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) A history of severe neurological diseases (e.g., epilepsy, brain tumors, cerebrovascular diseases, etc.); (2) A history of alcohol or substance abuse or dependence; (3) Pregnant or breastfeeding women; (4) A history of severe gastrointestinal diseases or recent (within the past 4 weeks) use of antibiotics, probiotics, prebiotics, or other agents that may affect gut microbiota; (5) Individuals allergic to any components of the medications used in this study; (6) Severe somatic diseases or infectious diseases; (7) Individuals who have participated in other clinical trials within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Young Mania Rating Scale (YMRS) Scoring;Gut microbiota a-diversity;Gut microbiota ß-diversity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impressions Scale (CGI);TCM Syndrome Score;Differential Analysis of Gut Microbiota;KEGG functional pathways;Microbiome-Clinical Relevance; | — |
Countries
China
Contacts
Public ContactXinyu Wu
Hunan Second People's Hospital (Hunan Brain Hospital)
Outcome results
None listed