Clinical trial NCT03235908: Copeptin in Outcome Prediction of an Acute Psychotic Episode
Official title: Copeptin - A Biomarker to Improve Outcome Prediction in Patients With an Acute Psychotic Episode
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Psychotic Episode
Schizophrenia Spectrum and Other Psychotic Disorders
Affective Disorder
Bipolar Disorder
Keywords: Copeptin
Outcome prediction
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are hospitalized with an acute psychotic episode within schizophrenia spectrum disorder, affective disorder and bipolar disorder.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Copeptin level
timeFrame: One year
Secondary outcomes:
measure: Change in copeptin levels
timeFrame: day 1 until day 30
measure: Recovery of psychotic episode
timeFrame: 1 year
measure: Discharge from hospital
timeFrame: one year
measure: Therapy Response assessed by symptom reduction of >30% in PANSS
timeFrame: 30 days
measure: Therapy Response measured by Global Assessment of Functioning (GAF) scale
timeFrame: 30 days
measure: Occurence of hyponatremia
timeFrame: 1 day
measure: Occurence of primary polydipsia
timeFrame: 1 day
measure: number of hospital re-admissions
timeFrame: 1 year
measure: social function after 12 months (functioning) after 12 months assessed by questionnaire
timeFrame: 1 year
measure: Severity of psychotic symptoms after 12 months compared to baseline assessed by questionnaire
timeFrame: 1 year
measure: psychological function (functioning) after 12 months compared to baseline assessed by questionnaire
timeFrame: 1 year
measure: operational function (functioning) after 12 months compared to baseline assessed by questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Mirjam Christ-Crain, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmidt A, Smieskova R, Aston J, Simon A, Allen P, Fusar-Poli P, McGuire PK, Riecher-Rossler A, Stephan KE, Borgwardt S. Brain connectivity abnormalities predating the onset of psychosis: correlation with the effect of medication. JAMA Psychiatry. 2013 Sep;70(9):903-12. doi: 10.1001/jamapsychiatry.2013.117.
citation: Balanescu S, Kopp P, Gaskill MB, Morgenthaler NG, Schindler C, Rutishauser J. Correlation of plasma copeptin and vasopressin concentrations in hypo-, iso-, and hyperosmolar States. J Clin Endocrinol Metab. 2011 Apr;96(4):1046-52. doi: 10.1210/jc.2010-2499. Epub 2011 Feb 2.
citation: Urwyler SA, Schuetz P, Sailer C, Christ-Crain M. Copeptin as a stress marker prior and after a written examination--the CoEXAM study. Stress. 2015 Jan;18(1):134-7. doi: 10.3109/10253890.2014.993966. Epub 2015 Jan 8.
citation: Siegenthaler J, Walti C, Urwyler SA, Schuetz P, Christ-Crain M. Copeptin concentrations during psychological stress: the PsyCo study. Eur J Endocrinol. 2014 Dec;171(6):737-42. doi: 10.1530/EJE-14-0405. Epub 2014 Sep 23.