Prolactin Change and Its Effectors in Chinese Patients With Schizophrenia After Antipsychotics Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,363
- 试验地点
- 1
- 主要终点
- prolactin level at first 1-month antipsychotic treatment
研究概览
简要总结
Objective:
Hyperprolactinemia(HPRL) which can result in a series of prolactin-related symptoms is a frequent adverse effect of antipsychotics. The investigators are interested to explicate the characteristics of serum prolactin level change after taking different antipsychotics and related factors.
Method:
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Review of electronic medical records of schizophrenia patients who were brought to Shanghai Mental Health Center since January 1, 2007.
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The investigators collect their information, and then
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set serum prolactin level after first 1-month antipsychotic treatment as primary outcome. Secondary outcomes are prolactin levels tested at other time points.
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Variables will range from antipsychotic kinds, dosage, treatment duration and blood concentration to demographic information, to disease history, to clinical treatment on hyperprolactinemia, to laboratory test results, such as blood routine examination, biochemistry, sex hormone levels and so on.
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After data cleaning and management, we will apply logistic regression, cox regression, Receiver Operating Characteristic curve (ROC) and machine learning to
- analyze factors of prolactin level;
- establish a model of prolactin change with time;
- propose optimal monitoring time of prolactin according to prolactin change with time;
- analyze correlation among antipsychotics, prolactin and clinical characters, for the purpose to supply objective evidence for antipsychotic treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed as schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders(DSM)-5;
- •were taking or going to take antipsychotics;
- •have the results of serum prolactin level.
排除标准
- •other mental disorder;
- •suffered endocrinic diseases of pituitary or thyroid gland;
- •suffered other organic brain diseases;
- •have the history of tobacco or alcohol abuse, or psychoactive drug substance abuse.
结局指标
主要结局
prolactin level at first 1-month antipsychotic treatment
时间窗: at first 1-month antipsychotic treatment
Serum prolactin level may change significantly after one month antipsychotic treatment.
次要结局
- prolactin level at other time points(after 2-month, 3-month and half a year treatment with antipsychotics)
研究者
LI, Huafang
Director and Clinical Professor
Shanghai Mental Health Center