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Trial record 17 of 1444 for:    Prediction | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03235908
Recruitment Status : Recruiting
First Posted : August 1, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.


Condition or disease Intervention/treatment
Acute Psychotic Episode Schizophrenia Spectrum and Other Psychotic Disorders Affective Disorder Bipolar Disorder 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
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Copeptin - A Biomarker to Improve Outcome Prediction in Patients With an Acute Psychotic Episode
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019


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




Primary Outcome Measures :
  1. Copeptin level [ Time Frame: One year ]
    Association of copeptin at inclusion with relapse rate of a psychotic episode within one year


Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Copeptin, Cortisol, Serum Sodium, Urinary sodium and urinary osmolality in case


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235908


Contacts
Contact: Clara O. Sailer +41 61 328 55 20 clara.sailer@usb.ch
Contact: Jennifer Küster jennifer.kuester@upkbs.ch

Locations
Switzerland
University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Clara Sailer         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Mirjam Christ-Crain, MD-PhD University Hospital, Basel, Switzerland

Publications of Results:
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03235908     History of Changes
Other Study ID Numbers: 2016-02198
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Basel, Switzerland:
Copeptin
Outcome prediction

Additional relevant MeSH terms:
Disease
Schizophrenia
Bipolar Disorder
Mental Disorders
Psychotic Disorders
Mood Disorders
Diabetes Insipidus
Schizophrenia Spectrum and Other Psychotic Disorders
Pathologic Processes
Bipolar and Related Disorders
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs