Copeptin - A Biomarker to Improve Outcome Prediction in Patients With an Acute Psychotic Episode
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Copeptin level
研究概览
简要总结
An acute psychotic episode is a severe psychiatric syndrome which might occur in different psychiatric diagnoses.
The outcome prediction of relapse rate of a psychotic episode within a certain time frame is difficult and depends on many factors. More and better predictors are required to improve the outcome prediction in order to adjust therapy and follow-up if patients suffer from this acute disease.
Copeptin, a surrogate marker for vasopressin, has been proven helpful in the prediction of the outcome in serious somatic diseases. Additionally, a rise of copeptin due to psychological stress was shown.
The aim of this study is to investigate the association of the neuroendocrine biomarker copeptin and the prediction of the onset of psychotic episode within one year.
详细描述
An acute psychotic episode is a severe psychiatric syndrome characterised by symptoms like delusions, hallucinations, and perceptual disturbances. A psychotic episode might occur in different psychiatric diagnoses, such as schizophrenia spectrum disorders and affective disorders (depression and bipolar).
The outcome prediction of relapse rate of a psychotic episode within a certain time frame is difficult and depends on many factors. More and better predictors are required to improve the outcome prediction in order to adjust therapy and follow-up if patients suffer from this acute disease.
Copeptin, a surrogate marker for vasopressin, has been proven helpful in the prediction of the outcome in serious somatic diseases such as stroke, myocardial infarction, and pneumonia. Additionally, a rise of copeptin due to psychological stress was shown.
Some studies have shown an increase in vasopressin levels during acute psychosis, no study has been performed using copeptin.
The aim of this study is to investigate the association of the neuroendocrine biomarker copeptin and the prediction of the onset of psychotic episode within one year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-55 years
- •Acute psychotic episode
- •Informed consent as documented by signature
排除标准
- •Limited discernment due to psychiatric disorder to give informed consent
- •Acute psychotic Episode due to any organic reason
- •Psychotic Episode due to psychotropic substances
- •Severe somatic disease (acute myocardial infarction, acute sepsis, acute stroke)
结局指标
主要结局
Copeptin level
时间窗: One year
Association of copeptin at inclusion with relapse rate of a psychotic episode within one year
次要结局
- Recovery of psychotic episode(1 year)
- Discharge from hospital(one year)
- Occurence of primary polydipsia(1 day)
- Severity of psychotic symptoms after 12 months compared to baseline assessed by questionnaire(1 year)
- operational function (functioning) after 12 months compared to baseline assessed by questionnaire(1 year)
- Change in copeptin levels(day 1 until day 30)
- Therapy Response assessed by symptom reduction of >30% in PANSS(30 days)
- Therapy Response measured by Global Assessment of Functioning (GAF) scale(30 days)
- number of hospital re-admissions(1 year)
- Occurence of hyponatremia(1 day)
- social function after 12 months (functioning) after 12 months assessed by questionnaire(1 year)
- psychological function (functioning) after 12 months compared to baseline assessed by questionnaire(1 year)