Copeptin in Outcome Prediction of an Acute Psychotic Episode (CoPsych)

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar Disorder; Acute Psychotic Episode; Affective Disorder
• Intervention / Treatment: Other: Observation only

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.

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with an acute psychosis; Acute psychosis in schizophrenia spectrum disorder, affective disorder and bipolar disorder; Observation only	Other: Observation only; Observation only

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Mirjam Christ-Crain, MD-PhD, University Hospital, Basel, Switzerland

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Outcome prediction; Copeptin
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Bipolar and Related Disorders; Pituitary Diseases; Schizophrenia; Disease; Psychotic Disorders; Mental Disorders; Bipolar Disorder; Mood Disorders; Diabetes Insipidus; Schizophrenia Spectrum and Other Psychotic Disorders
• Other Study ID Numbers: 2016-02198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No