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Completed

NCT Number: NCT03235908

Copeptin in Outcome Prediction of 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

observation only

Other

Observation only

Primary outcomes

  1. Copeptin level

    Time frame: One year

    Association of copeptin at inclusion with relapse rate of a psychotic episode within one year

Secondary outcomes

  1. Change in copeptin levels

    Time frame: day 1 until day 30

    Change in copeptin levels from day 1 until day 30

  2. Recovery of psychotic episode

    Time frame: 1 year

    Time until recovery from the Initial psychotic Episode assessed after 30 days and one year

  3. Discharge from hospital

    Time frame: one year

    Time until discharge from hospital assessed after 30 days and one year

  4. Therapy Response assessed by symptom reduction of >30% in PANSS

    Time frame: 30 days

    Therapy Response defined as symptom reduction of >30% in PANSS assessed after 30 days

  5. Therapy Response measured by Global Assessment of Functioning (GAF) scale

    Time frame: 30 days

    Therapy Response measured by Global Assessment of Functioning (GAF) scale assessed after 30 days

  6. Occurence of hyponatremia

    Time frame: 1 day

    Incidence of hyponatremia during an acute psychotic episode assessed at baseline

  7. Occurence of primary polydipsia

    Time frame: 1 day

    Incidence of primary polydipsia in patients with an acute psychotic episode assessed by reported amount of drinking at baseline

  8. number of hospital re-admissions

    Time frame: 1 year

    re-admission rate due to a psychotic episode observed over 1 year

  9. social function after 12 months (functioning) after 12 months assessed by questionnaire

    Time frame: 1 year

    social function after 12 months

  10. Severity of psychotic symptoms after 12 months compared to baseline assessed by questionnaire

    Time frame: 1 year

    Severity of psychotic symptoms (functioning) after 12 months

  11. psychological function (functioning) after 12 months compared to baseline assessed by questionnaire

    Time frame: 1 year

    psychological function (functioning) after 12 months

  12. operational function (functioning) after 12 months compared to baseline assessed by questionnaire

    Time frame: 1 year

    operational function (functioning) after 12 months

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: CoPsych

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 1, 2017
Registry last updated
Sep 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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