Copeptin in Outcome Prediction of an Acute Psychotic Episode

Bipolar Disorder Clinical Trial

— CoPsych  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03235908
• Other study ID #: 2016-02198
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: July 31, 2020

Study information

• Verified date: September 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Psychotic Episode
• Affective Disorder
• Bipolar Disorder
• Diabetes Insipidus
• Disease
• Mental Disorders
• Mood Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophrenia Spectrum and Other Psychotic Disorders

Intervention

Other:
• Observation only
Observation only

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

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 — View Citation

Schmidt A, Smieskova R, Aston J, Simon A, Allen P, Fusar-Poli P, McGuire PK, Riecher-Rössler A, Stephan KE, Borgwardt S. Brain connectivity abnormalities predating the onset of psychosis: correlation with the effect of medication. JAMA Psychiatry. 2013 Se — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Copeptin level	Association of copeptin at inclusion with relapse rate of a psychotic episode within one year	One year
Secondary	Change in copeptin levels	Change in copeptin levels from day 1 until day 30	day 1 until day 30
Secondary	Recovery of psychotic episode	Time until recovery from the Initial psychotic Episode assessed after 30 days and one year	1 year
Secondary	Discharge from hospital	Time until discharge from hospital assessed after 30 days and one year	one year
Secondary	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
Secondary	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
Secondary	Occurence of hyponatremia	Incidence of hyponatremia during an acute psychotic episode assessed at baseline	1 day
Secondary	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
Secondary	number of hospital re-admissions	re-admission rate due to a psychotic episode observed over 1 year	1 year
Secondary	social function after 12 months (functioning) after 12 months assessed by questionnaire	social function after 12 months	1 year
Secondary	Severity of psychotic symptoms after 12 months compared to baseline assessed by questionnaire	Severity of psychotic symptoms (functioning) after 12 months	1 year
Secondary	psychological function (functioning) after 12 months compared to baseline assessed by questionnaire	psychological function (functioning) after 12 months	1 year
Secondary	operational function (functioning) after 12 months compared to baseline assessed by questionnaire	operational function (functioning) after 12 months	1 year