Copeptin in Outcome Prediction of an Acute Psychotic Episode

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Copeptin - A Biomarker to Improve Outcome Prediction in Patients With an Acute Psychotic Episode

Conditions
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Acute Psychotic Episode, Schizophrenia Spectrum and Other Psychotic Disorders, Affective Disorder, Bipolar Disorder

Intervention / Treatment
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* Other: Observation only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-55 years Acute psychotic episode Informed consent as documented by signature Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with an acute psychosis<br>Acute psychosis in schizophrenia spectrum disorder, affective disorder and bipolar disorder; Observation only | Other: Observation only<br>* Observation only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Copeptin level | Association of copeptin at inclusion with relapse rate of a psychotic episode within one year | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in copeptin levels | Change in copeptin levels from day 1 until day 30 | day 1 until day 30 | 
| Recovery of psychotic episode | Time until recovery from the Initial psychotic Episode assessed after 30 days and one year | 1 year | 
| Discharge from hospital | Time until discharge from hospital assessed after 30 days and one year | one year | 
| Therapy Response assessed by symptom reduction of >30% in PANSS | Therapy Response defined as symptom reduction of >30% in PANSS assessed after 30 days | 30 days | 
| Therapy Response measured by Global Assessment of Functioning (GAF) scale | Therapy Response measured by Global Assessment of Functioning (GAF) scale assessed after 30 days | 30 days | 
| Occurence of hyponatremia | Incidence of hyponatremia during an acute psychotic episode assessed at baseline | 1 day | 
| Occurence of primary polydipsia | Incidence of primary polydipsia in patients with an acute psychotic episode assessed by reported amount of drinking at baseline | 1 day | 
| number of hospital re-admissions | re-admission rate due to a psychotic episode observed over 1 year | 1 year | 
| social function after 12 months (functioning) after 12 months assessed by questionnaire | social function after 12 months | 1 year | 
| Severity of psychotic symptoms after 12 months compared to baseline assessed by questionnaire | Severity of psychotic symptoms (functioning) after 12 months | 1 year | 
| psychological function (functioning) after 12 months compared to baseline assessed by questionnaire | psychological function (functioning) after 12 months | 1 year | 
| operational function (functioning) after 12 months compared to baseline assessed by questionnaire | operational function (functioning) after 12 months | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Copeptin, Outcome prediction