Phase 4 Study of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- change of weight
研究概览
简要总结
The purpose of this study is the evaluation of effect of metformin on obesity and metabolic disturbance in patients taking clozapine.
详细描述
In this study, the investigators are going to examine the effect of metformin on obesity and metabolic disturbance in patients with schizophrenia who have taken clozapine.The metformin 500mg will be administrated per oral twice a day for 24 weeks and for control group, placebo will be given same route and process.
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
- •Age: 18 ~ 65
- •Patient with schizophrenia according to DSM-IV criteria
- •Patient have signed on the informed consent, and well understood the objective and procedure of this study.
- •Patient taking clozapine 3months or more
- •Patient increased in weight more than 10 % of that of before antipsychotics use
排除标准
- •Patient taking other antipsychotics with clozapine
- •Patient in treatment of diabetes
- •Patient in treatment of dyslipidemia
- •Allergy or hypersensitivity to metformin
- •Pregnant or breast-feeding female patient.
- •Patient with severe medical condition
研究组 & 干预措施
Metformin group
Metformin 500mg 1 tablet p.o. bid
干预措施: Metformin (Drug)
Placebo group
1 tablet p.o. bid
干预措施: Placebo (for metformin) (Drug)
结局指标
主要结局
change of weight
时间窗: baseline, 12 weeks, 24 weeks
change of weight after 12-week, 24-week. calculation; (weight of 12-week - weight of baseline)/baseline weight (weight of 24-week - weight of baseline)/baseline weight
次要结局
- Liverpool University Neuroleptic Side Effect Rating Scale(LUNSERS)(baseline, 12 weeks, 24 weeks)
- World Health Organization Quality of Life-BREF (WHOQOL-BREF)(baseline, 12 weeks, 24 weeks)
- Positive and Negative Symptom Scale(PANSS)(baseline, 12 weeks, 24 weeks)
- MADRS(montgomery asberg depression rating scale)(baseline, 12 weeks, 24 weeks)
- Clinical Global Impression-severity(CGI-S)(baseline, 6 weeks, 24 weeks)
- Clinical Global Impression-improvement(CGI-I)(baseline, 12 weeks, 24 weeks)
- Beck's Depression Inventory(BDI)(baseline, 12 weeks, 24 weeks)
- Short form(36) Health survey (SF-36)(baseline, 12 weeks, 24 weeks)
- abdominal fat amount CT(baseline, 12 weeks, 24 weeks)
- change of prevalence of metabolic syndrome(baseline, 12 weeks, 24 weeks)
研究者
Yong Min Ahn
professor
Seoul National University Hospital