Copeptin in Outcome Prediction of an Acute Psychotic Episode
- Conditions
- Bipolar DisorderSchizophrenia Spectrum and Other Psychotic DisordersAffective DisorderAcute Psychotic Episode
- Interventions
- Other: Observation only
- Registration Number
- NCT03235908
- Lead Sponsor
- University Hospital, Basel, Switzerland
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
- Age 18-55 years
- Acute psychotic episode
- Informed consent as documented by signature
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with an acute psychosis Observation only Acute psychosis in schizophrenia spectrum disorder, affective disorder and bipolar disorder; Observation only
- Primary Outcome Measures
Name Time Method Copeptin level One year Association of copeptin at inclusion with relapse rate of a psychotic episode within one year
- Secondary Outcome Measures
Name Time Method Recovery of psychotic episode 1 year Time until recovery from the Initial psychotic Episode assessed after 30 days and one year
Discharge from hospital one year Time until discharge from hospital assessed after 30 days and one year
Occurence of primary polydipsia 1 day Incidence of primary polydipsia in patients with an acute psychotic episode assessed by reported amount of drinking at baseline
Severity of psychotic symptoms after 12 months compared to baseline assessed by questionnaire 1 year Severity of psychotic symptoms (functioning) after 12 months
operational function (functioning) after 12 months compared to baseline assessed by questionnaire 1 year operational function (functioning) after 12 months
Change in copeptin levels day 1 until day 30 Change in copeptin levels from day 1 until day 30
Therapy Response assessed by symptom reduction of >30% in PANSS 30 days Therapy Response defined as symptom reduction of \>30% in PANSS assessed after 30 days
Therapy Response measured by Global Assessment of Functioning (GAF) scale 30 days Therapy Response measured by Global Assessment of Functioning (GAF) scale assessed after 30 days
number of hospital re-admissions 1 year re-admission rate due to a psychotic episode observed over 1 year
Occurence of hyponatremia 1 day Incidence of hyponatremia during an acute psychotic episode assessed at baseline
social function after 12 months (functioning) after 12 months assessed by questionnaire 1 year social function after 12 months
psychological function (functioning) after 12 months compared to baseline assessed by questionnaire 1 year psychological function (functioning) after 12 months
Trial Locations
- Locations (1)
University Hospital Basel
🇨🇭Basel, Switzerland