Berberine Treat Metabolic Syndrome in Schizophrenia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Berberine in the Treatment of Metabolic Syndrome : an Open Label Clinical Study in Female Schizophrenia Patients

Conditions
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Metabolic Syndrome, Female, Schizophrenia

Intervention / Treatment
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* Drug: berberine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects with the diagnosis of schizophrenia depend on Statistical Manual, Fifth Edition (DSM-5) ; Female subjects aged 18-60 years; monotherapy of atypical antipsychotics for 2 weeks or more , including olanzapine, clozapine, risperidone, and perphenazine； subjects with diagnosis of metabolic syndrome depending on guidelines for the prevention and treatment of dyslipidemia in Chinese adults in 2007; the subjects and their guardians sign the informed consent agreement. Exclusion Criteria: subjects with diagnosis of other psychiatric disorders except schizophrenia depend on DSM-5; 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; a history of gastrointestinal surgery or the presence of any possibility of interfering with the absorption, distribution, metabolism, or excretion of drugs situation; used long-acting antipsychotic drugs or receive electroconvulsive therapy (MECT) or receive transcranial magnetic stimulation therapy in the last 1 months; serious physical diseases, including uncontrolled hypertension, severe cardiovascular, cerebrovascular, and pulmonary diseases, thyroid diseases, etc; currently receiving anti-inflammatory or immunosuppressive treatment, including oral steroids; a history of chronic infection, including tuberculosis, AIDS and hepatitis; allergic to berberine,or hemolytic anemia or glucose -6- phosphate dehydrogenase deficiency; pregnant women, lactating women； participants were involved in other clinical trials within 1 months prior to the signing of informed consent other reasons judged by the researchers to be inappropriate for the clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: berberine adjunctive group<br>Only one treatment group in this study, without a preset control group,subjects who meet the criteria will entere the berberine adjunctive group | Drug: berberine<br>* berberine 300mg TID add-on for berberine adjunctive group<br>* Other names: berberine hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of FBG | Serum fasting biood glucose | Change from Baseline serum fasting biood glucose at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of TG | Serum triglyceride | Change from Baseline serum triglyceride at 8 weeks | 
| Change of LDL | Serum low density lipoprotein | Change from Baseline serum low density lipoprotein at 8 weeks | 
| Change of BP | Systolic blood pressure | Change from Baseline Systolic Blood Pressure at 8 weeks | 
| Change of waist | Waistline | Change from Baseline waistline at 8 weeks | 
| Change of BP | Diastolic blood pressure | Change from Baseline Diastolic Blood Pressure at 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Metabolic syndrome, Efficacy, Female, Berberine