Comparison of the Efficacy and Safety of Berberine and Metformin for Schizophrenia Patients With Metabolic Syndrome
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes of Fasting blood samples for Fasting blood glucose(FBG)
研究概览
简要总结
Berberine is an isoquinoline alkaloid extracted from medicinal herbs, has been demonstrated to produce beneficial effects on diabetes and hyperlipidemia, fewer study reported its modification on lipid metabolism in schizophrenia. Metformin, have been used for metabolic abnormalities in schizophrenia, findings from these studies indicated that they did have some effect,which are still in experimental stage.This study is aim to compare the efficacy and safety of berberine and metformin for preventing metabolic dysfunction in schizophrenia patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In accordance with criteria set out in the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV )Axis I Disorders, Clinical Version;
- •Meet metabolic syndrome based on Guidelines for Prevention and Treatment of Blood Lipid Abnormality in Chinese Adults(2007);
- •Have taken stable dose of the current single antipsychotic drug for at least one month;
- •Female subjects will be enrolled to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study.
排除标准
- •Individuals who refuse to provide informed consent;
- •Currently substance abuse or psychiatrically unstable per treating clinician's judgment;
- •One with significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases also not suitable for this trial;
- •Currently on anti-inflammatory or immunosuppressant medication including oral steroids and history of chronic infection (including tuberculosis, HIV and hepatitis), malignancy, organ transplantation, blood dyscrasia, central nervous system demyelinating disorder, and any other known autoimmune or inflammatory condition pregnancy or breastfeeding.
研究组 & 干预措施
Berberine group
Berberine 300mg（three times a day） plus Metformin simulant 250mg（three times a day）agent plus any atypical antipsychotic drug
Metformin simulant were matched to metformin in shape, smell and colour were sealed in identical bottles
干预措施: Berberine (Drug)
Metformin group
Metformin 250mg（three times a day） plus Berberine simulant 250mg（three times a day）agent plus any atypical antipsychotic drug
Berberine simulant were matched to Berberine in shape, smell and colour were sealed in identical bottles
干预措施: Metformin (Drug)
结局指标
主要结局
Changes of Fasting blood samples for Fasting blood glucose(FBG)
时间窗: 0, 4, 8,12 weeks
The main objective is to compare Berberine with Metformin on the effect of reducing the levels of FBG in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment
Changes of Triglyceride(TG)
时间窗: 0, 4, 8,12 weeks
The main objective is to compare Berberine with Metformin on the effect of reducing the levels of TG in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment
Changes of High-Density Lipoprotein (HDL)
时间窗: 0, 4, 8,12 weeks
The main objective is to compare Berberine with Metformin on the effect of reducing the levels of HDL in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment
Changes of Waist circumference(WC)
时间窗: 0, 4, 8,12 weeks
The main objective is to compare Berberine with Metformin on the effect of reducing the levels of WC in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment
Changes of Blood pressure (BP)，including systolic and diastolic pressure
时间窗: 0, 4, 8,12 weeks
The main objective is to compare Berberine with Metformin on the effect of reducing the levels of systolic or diastolic pressure in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment
次要结局
- Changes of Positive and Negative Syndrome Scale（PANSS）scores(0, 4, 8,12 weeks)
- Changes of Total Cholesterol(TC)(0, 4, 8,12 weeks)
- Changes of C reactive protein(0, 4, 8,12 weeks)
- Changes of Interleukin-1β,Interleukin-6,tumor necrosis factor(TNF-α)(0, 4, 8,12 weeks)
- Changes of Body mass index(BMI)(0, 4, 8,12 weeks)