Acute Psychotic EpisodeCoPsychNCT03235908
Copeptin in Outcome Prediction of an Acute Psychotic Episode
An observational study of Acute Psychotic Episode and Schizophrenia Spectrum and Other Psychotic Disorders, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Acute Psychotic Episode, Schizophrenia Spectrum and Other Psychotic Disorders, Affective Disorder
- What is being tested?
- Observation only
- How many people
- 73 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2017to 31 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients who are hospitalized with an acute psychotic episode within schizophrenia spectrum disorder, affective disorder and bipolar disorder.
Who may be able to join
- Age 18-55 years
- Acute psychotic episode
- Informed consent as documented by signature
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Copeptin - A Biomarker to Improve Outcome Prediction in Patients With 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.
Read more
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.
Read the 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.
- Conditions
- Acute Psychotic Episode, Schizophrenia Spectrum and Other Psychotic Disorders, Affective Disorder, Bipolar Disorder
- Being tested
- Observation only
- Keywords
- Copeptin, Outcome prediction
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders, Mood Disorders, Bipolar Disorder, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation onlyOther
Observation only
| Study group | Role | What they receive |
|---|---|---|
| Patients with an acute psychosis | Acute psychosis in schizophrenia spectrum disorder, affective disorder and bipolar disorder; Observation only Receives: Other: Observation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Copeptin level
Association of copeptin at inclusion with relapse rate of a psychotic episode within one year
Measured: One year
Secondary outcomes (12)
Change in copeptin levels
Change in copeptin levels from day 1 until day 30
Measured: day 1 until day 30
Recovery of psychotic episode
Time until recovery from the Initial psychotic Episode assessed after 30 days and one year
Measured: 1 year
Discharge from hospital
Time until discharge from hospital assessed after 30 days and one year
Measured: one year
Therapy Response assessed by symptom reduction of >30% in PANSS
Therapy Response defined as symptom reduction of >30% in PANSS assessed after 30 days
Measured: 30 days
Therapy Response measured by Global Assessment of Functioning (GAF) scale
Therapy Response measured by Global Assessment of Functioning (GAF) scale assessed after 30 days
Measured: 30 days
Occurence of hyponatremia
Incidence of hyponatremia during an acute psychotic episode assessed at baseline
Measured: 1 day
Occurence of primary polydipsia
Incidence of primary polydipsia in patients with an acute psychotic episode assessed by reported amount of drinking at baseline
Measured: 1 day
number of hospital re-admissions
re-admission rate due to a psychotic episode observed over 1 year
Measured: 1 year
social function after 12 months (functioning) after 12 months assessed by questionnaire
social function after 12 months
Measured: 1 year
Severity of psychotic symptoms after 12 months compared to baseline assessed by questionnaire
Severity of psychotic symptoms (functioning) after 12 months
Measured: 1 year
psychological function (functioning) after 12 months compared to baseline assessed by questionnaire
psychological function (functioning) after 12 months
Measured: 1 year
operational function (functioning) after 12 months compared to baseline assessed by questionnaire
operational function (functioning) after 12 months
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start1 May 2017
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Psychotic EpisodeStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirjam Christ-Crain, MD-PhD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235908
- Sponsor's protocol ID
- 2016-02198
- Other IDs
- 2016
- Acronym
- CoPsych
- Status last verified
- Sep 2020
- First submitted
- 25 Jul 2017
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23824230Balanescu 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.
PubMed 21289257Urwyler 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.
PubMed 25472823Siegenthaler 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.
PubMed 25249697
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copeptin - A Biomarker to Improve Outcome Prediction in Patients With an Acute Psychotic Episode
- ClinicalTrials.gov ID
- NCT03235908
- Acronym / sponsor ID
- CoPsych / 2016-02198
- Conditions
- Acute Psychotic Episode, Schizophrenia Spectrum and Other Psychotic Disorders, Affective Disorder, Bipolar Disorder
- Keywords
- Copeptin, Outcome prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with an acute psychosis | – | Other: Observation onlyAcute psychosis in schizophrenia spectrum disorder, affective disorder and bipolar disorder; Observation only |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who are hospitalized with an acute psychotic episode within schizophrenia spectrum disorder, affective disorder and bipolar disorder.
Key inclusion criteria (3 listed)
- Age 18-55 years
- Acute psychotic episode
- Informed consent as documented by signature
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation onlyObservation only | Other | Patients with an acute psychosis |
Primary outcome
Copeptin level
Time frame: One year
Association of copeptin at inclusion with relapse rate of a psychotic episode within one year
12 secondary outcomes
Change in copeptin levels
Time frame: day 1 until day 30
Recovery of psychotic episode
Time frame: 1 year
Discharge from hospital
Time frame: one year
Therapy Response assessed by symptom reduction of >30% in PANSS
Time frame: 30 days
Therapy Response measured by Global Assessment of Functioning (GAF) scale
Time frame: 30 days
Occurence of hyponatremia
Time frame: 1 day
Occurence of primary polydipsia
Time frame: 1 day
number of hospital re-admissions
Time frame: 1 year
social function after 12 months (functioning) after 12 months assessed by questionnaire
Time frame: 1 year
Severity of psychotic symptoms after 12 months compared to baseline assessed by questionnaire
Time frame: 1 year
psychological function (functioning) after 12 months compared to baseline assessed by questionnaire
Time frame: 1 year
operational function (functioning) after 12 months compared to baseline assessed by questionnaire
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Results publication: PubMed 23824230Schmidt 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.
- Results publication: PubMed 21289257Balanescu 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.
- Results publication: PubMed 25472823Urwyler 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.
- Results publication: PubMed 25249697Siegenthaler 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirjam Christ-Crain, MD-PhD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Psychotic Episode and Schizophrenia Spectrum and Other Psychotic Disorders, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Copeptin level (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03235908, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.