NCT03235908

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

3.3 years

First QC Date

July 25, 2017

Last Update Submit

September 18, 2020

Conditions

Acute Psychotic EpisodeSchizophrenia Spectrum and Other Psychotic DisordersAffective DisorderBipolar Disorder

Keywords

CopeptinOutcome prediction

Outcome Measures

Primary Outcomes (1)

  • Copeptin level

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

    One year

Secondary Outcomes (12)

  • Change in copeptin levels

    day 1 until day 30

  • Recovery of psychotic episode

    1 year

  • Discharge from hospital

    one year

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

    30 days

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

    30 days

  • +7 more secondary outcomes

Study Arms (1)

Patients with an acute psychosis

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

Other: Observation only

Interventions

Observation onlyOTHER

Observation only

Patients with an acute psychosis

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who are hospitalized with an acute psychotic episode within schizophrenia spectrum disorder, affective disorder and bipolar disorder.

You may qualify if:

  • Age 18-55 years
  • Acute psychotic episode
  • Informed consent as documented by signature

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (4)

  • 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.

    PMID: 23824230RESULT

  • 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.

    PMID: 21289257RESULT

  • 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.

    PMID: 25472823RESULT

  • 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.

    PMID: 25249697RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Copeptin, Cortisol, Serum Sodium, Urinary sodium and urinary osmolality in case

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic DisordersMood DisordersBipolar DisorderDiabetes Insipidus

Condition Hierarchy (Ancestors)

Mental DisordersBipolar and Related DisordersKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Study Officials

  • Mirjam Christ-Crain, MD-PhD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2017

First Posted

August 1, 2017

Study Start

May 1, 2017

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

September 21, 2020

Record last verified: 2020-09

Locations

CH(1)