Copeptin in Outcome Prediction of an Acute Psychotic Episode

NCT ID: NCT03235908

Last Updated: 2020-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2020-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with an acute psychosis

Acute psychosis in schizophrenia spectrum disorder, affective disorder and bipolar disorder; Observation only

Observation only

Intervention Type OTHER

Observation only

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Observation only

Observation only

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mirjam Christ-Crain, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Basel

Basel, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 23824230 (View on PubMed)

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.

Reference Type RESULT
PMID: 21289257 (View on PubMed)

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.

Reference Type RESULT
PMID: 25472823 (View on PubMed)

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.

Reference Type RESULT
PMID: 25249697 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016-02198

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Depakote ER in Bipolar Depression
NCT00186186 COMPLETED PHASE4