Predictive Models of Clinical Efficacy and Adverse Reactions of Antipsychotic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Insulin level
研究概览
简要总结
The goal of this clinical trial is to explore the potential of metformin in managing olanzapine-induced metabolic disturbance and hyperprolactinemia in patients with schizophrenia. The main questions it aims to answer are:
- The effect of metformin on olanzapine-induced metabolic disturbance
- The effect of metformin on olanzapine-induced hyperprolactinemia
Participants will receive metformin 1500 mg/day for 8 weeks and assessments every 2 weeks.
详细描述
The study was conducted in an inpatient setting, with the dosage of olanzapine remaining consistent throughout the study duration. All participants were administered 1500 mg/day of metformin for eight weeks. Vital signs were measured daily. Physical and neurological examinations were carried out on a weekly basis. Every two weeks, all participants underwent an assessment for general psychopathology. Blood samples were collected in the morning after an overnight fast at the beginning of the study and then every two weeks following the commencement of metformin treatment. Serum prolactin levels were determined through electrochemiluminescence immunoassays. Fasting serum levels of glucose, total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglycerides were measured using enzymatic colorimetric assays. Serum insulin and leptin levels were measured using electrochemiluminescence immunoassay kits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 18 and 60 years
- •diagnosed with schizophrenia under the Diagnostic and Statistical Manual of Mental Disorders-fourth edition criteria
- •had been consistently treated with a stable dose of olanzapine for a minimum of three months
排除标准
- •Exclusion criteria encompassed any mental disorder other than schizophrenia, ongoing substance abuse, and medical conditions that could interfere with glucoregulatory and endocrine assessment such as diabetes mellitus and other endocrine disorders. Additionally, severe cardiovascular, hepatic, or renal diseases, malignancy, epilepsy, and pregnancy were also reasons for exclusion.
研究组 & 干预措施
metformin intervention
All participants were administered 1500 mg/day of metformin for eight weeks.
干预措施: Metformin (Drug)
结局指标
主要结局
Insulin level
时间窗: 8 weeks
insulin level was measured every 2 weeks
Glucose level
时间窗: 8 weeks
Glucose level was measured every 2 weeks.
prolactin level
时间窗: 8 weeks
Prolactin level was assessed every 2 weeks.
cholesterol level
时间窗: 8 weeks
cholesterol level was measured every 2 weeks
triglycerides level
时间窗: 8 weeks
triglycerides level was measured every 2 weeks
leptin level
时间窗: 8 weeks
leptin level was measured every 2 weeks
low-density lipoprotein cholesterol (LDL-C) level
时间窗: 8 weeks
LDL-C level was measured every 2 weeks
high-density lipoprotein cholesterol (HDL-C) level
时间窗: 8 weeks
HDL-C level was measured every 2 weeks
次要结局
- Clinical Global Impression scale(8 weeks)