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Copeptin in Outcome Prediction of an Acute Psychotic Episode

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03235908
Acronym
CoPsych
Enrollment
73
Registered
2017-08-01
Start date
2017-05-01
Completion date
2020-07-31
Last updated
2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Copeptin, Outcome prediction

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.

Interventions

OTHERObservation only

Observation only

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Copeptin levelOne yearAssociation of copeptin at inclusion with relapse rate of a psychotic episode within one year

Secondary

MeasureTime frameDescription
Recovery of psychotic episode1 yearTime until recovery from the Initial psychotic Episode assessed after 30 days and one year
Discharge from hospitalone yearTime until discharge from hospital assessed after 30 days and one year
Therapy Response assessed by symptom reduction of >30% in PANSS30 daysTherapy Response defined as symptom reduction of \>30% in PANSS assessed after 30 days
Therapy Response measured by Global Assessment of Functioning (GAF) scale30 daysTherapy Response measured by Global Assessment of Functioning (GAF) scale assessed after 30 days
Occurence of hyponatremia1 dayIncidence of hyponatremia during an acute psychotic episode assessed at baseline
Change in copeptin levelsday 1 until day 30Change in copeptin levels from day 1 until day 30
number of hospital re-admissions1 yearre-admission rate due to a psychotic episode observed over 1 year
social function after 12 months (functioning) after 12 months assessed by questionnaire1 yearsocial function after 12 months
Severity of psychotic symptoms after 12 months compared to baseline assessed by questionnaire1 yearSeverity of psychotic symptoms (functioning) after 12 months
psychological function (functioning) after 12 months compared to baseline assessed by questionnaire1 yearpsychological function (functioning) after 12 months
operational function (functioning) after 12 months compared to baseline assessed by questionnaire1 yearoperational function (functioning) after 12 months
Occurence of primary polydipsia1 dayIncidence of primary polydipsia in patients with an acute psychotic episode assessed by reported amount of drinking at baseline

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026