Efficacy and Safety of Metformin in Preventing Patients With Risperidone From Weight Gain and Amenorrhea:a 24-week, Randomized, Placebo-controlled, Double-blind, Fixed-dose Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change from Baseline in weight at 24 weeks
研究概览
简要总结
Some previous studies has demonstrated that Metformin can improve the weight gain which caused by antipsychotics. An our study, which will be published, also found that Metformin can improve the amenorrhea for patients with antipsychotics, approximately 60% patients recovery period. So the present study was designed to investigate the efficacy and safety of Metformin in preventing patients with Risperidone from weight gain and amenorrhea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age 18-40 years.
- •diagnosis of schizophrenia (naive first-episode) as defined in DSM-IV axis I.
- •At screening, patients were required to have total score ≥60 on Positive and Negative Syndrome Scale (PANSS) and ≥4 on the Clinical Global Impression-severity scale (CGI-S).
- •treat with Risperidone.
- •Never participate in a diet control nor in other weight loss programs, and have a normal Period.
- •Written informed consents could be obtained from patients(or their Legal guardian).
排除标准
- •Female patients, those who were in the period of pregnancy and lactation, or plan pregnancy, were excluded.
- •Patients with serious physical disease patients, just like Epilepsy, liver and kidney dysfunction, diabetes, blood diseases, etc were excluded.
- •At screening, patients with abnormal results in physical examination, laboratory test, or electrocardiogram (ECG) were excluded.
- •Patients were also excluded if they met primary DSM-IV axis I psychiatric disorders other than schizophrenia, or ever used psychoactive substance.
研究组 & 干预措施
efficacy and safety
To investigate the efficacy and safety of Metformin in preventing patients with Risperidone from weight gain and amenorrhea.
干预措施: Metformin (Drug)
placebo comparator
To investigate whether plcebo also could preventing patients with Risperidone from weight gain and amenorrhea.
干预措施: Starch tablets (Other)
结局指标
主要结局
Change from Baseline in weight at 24 weeks
时间窗: baseline, 8 week, 16 week, 24 week
The data will be presented
次要结局
- Change from Baseline in menstruation at 24 weeks(baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week)
研究者
Jing-Ping Zhao
Professor,Deputy Director of Mental Health Institute of The Second Xiangya Hospital
Central South University