Copeptin in Outcome Prediction of an Acute Psychotic Episode | NCT03235908

Studies
Copeptin in Outcome Prediction of an Acute Psychotic Episode

NCT03235908

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Sep 21, 2020Actual

Enrollment

73Actual

Phase

Not provided

Conditions

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

Interventions

Observation only

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2017Actual

Primary Completion Date

Jul 31, 2020Actual

Completion Date

Jul 31, 2020Actual

First Submitted Date

Jul 25, 2017

First Submission Date that Met QC Criteria

Jul 27, 2017

First Posted Date

Aug 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2020

Last Update Posted Date

Sep 21, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

73Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with an acute psychosis		Acute psychosis in schizophrenia spectrum disorder, affective disorder and bipolar disorder; Observation only	Other: Observation only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation only	Other	Observation only	Patients with an acute psychosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Copeptin level	Association of copeptin at inclusion with relapse rate of a psychotic episode within one year	One year

Secondary Outcomes

Measure	Description	Time Frame
Change in copeptin levels	Change in copeptin levels from day 1 until day 30	day 1 until day 30
Recovery of psychotic episode	Time until recovery from the Initial psychotic Episode assessed after 30 days and one year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mirjam Christ-Crain, MD-PhD	University Hospital, Basel, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Basel		Basel		4031	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23824230	Result	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.
21289257	Result

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D019964	Mood Disorders
D001714	Bipolar Disorder
D003919	Diabetes Insipidus

ID	Term
D001523	Mental Disorders
D000068105	Bipolar and Related Disorders
D007674	Kidney Diseases
D014570	Urologic Diseases