Female, Metabolic Syndrome, Schizophrenia
Conditions
Keywords
Metabolic syndrome, Schizophrenia, Efficacy, Female, Berberine
Brief summary
In early clinical study investigators confirmed that berberine could prevent glucose and lipid metabolism disorder in schizophrenia, so investigators intend to verify the effect and safety of berberine in treatment for metabolic syndrome in schizophrenia.
Detailed description
This study is an open lable clinical intervention trial, include 30 female subjects with diagnosis of schizophrenia and metabolic syndrome.Participants will be given berberine（ 300mgTID） as an add-on therapy lasting 8 weeks.
Interventions
DRUGberberine
berberine 300mg TID add-on for berberine adjunctive group
Sponsors
Tianjin Anding Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. subjects with the diagnosis of schizophrenia depend on Statistical Manual, Fifth Edition (DSM-5) ; 2. Female subjects aged 18-60 years; 3. monotherapy of atypical antipsychotics for 2 weeks or more , including olanzapine, clozapine, risperidone, and perphenazine； 4. subjects with diagnosis of metabolic syndrome depending on guidelines for the prevention and treatment of dyslipidemia in Chinese adults in 2007; 5. the subjects and their guardians sign the informed consent agreement.
Exclusion criteria
1. subjects with diagnosis of other psychiatric disorders except schizophrenia depend on DSM-5; 2. chronic organic diseases involving any central nervous system, such as tumors and inflammation, brain trauma, active seizures, vascular diseases, Parkinson's disease, myasthenia gravis, and other degenerative diseases; 3. a history of gastrointestinal surgery or the presence of any possibility of interfering with the absorption, distribution, metabolism, or excretion of drugs situation; 4. used long-acting antipsychotic drugs or receive electroconvulsive therapy (MECT) or receive transcranial magnetic stimulation therapy in the last 1 months; 5. serious physical diseases, including uncontrolled hypertension, severe cardiovascular, cerebrovascular, and pulmonary diseases, thyroid diseases, etc; 6. currently receiving anti-inflammatory or immunosuppressive treatment, including oral steroids; 7. a history of chronic infection, including tuberculosis, AIDS and hepatitis; 8. allergic to berberine,or hemolytic anemia or glucose -6- phosphate dehydrogenase deficiency; 9. pregnant women, lactating women； 10. participants were involved in other clinical trials within 1 months prior to the signing of informed consent 11. other reasons judged by the researchers to be inappropriate for the clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of FBG | Change from Baseline serum fasting biood glucose at 8 weeks | Serum fasting biood glucose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of TG | Change from Baseline serum triglyceride at 8 weeks | Serum triglyceride |
| Change of LDL | Change from Baseline serum low density lipoprotein at 8 weeks | Serum low density lipoprotein |
| Change of BP | Change from Baseline Systolic Blood Pressure at 8 weeks | Systolic blood pressure |
| Change of waist | Change from Baseline waistline at 8 weeks | Waistline |
Countries
China
Outcome results
None listed