<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03235908</url>
  </required_header>
  <id_info>
    <org_study_id>2016-02198</org_study_id>
    <nct_id>NCT03235908</nct_id>
  </id_info>
  <brief_title>Copeptin in Outcome Prediction of an Acute Psychotic Episode</brief_title>
  <acronym>CoPsych</acronym>
  <official_title>Copeptin - A Biomarker to Improve Outcome Prediction in Patients With an Acute Psychotic Episode</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      An acute psychotic episode is a severe psychiatric syndrome which might occur in different&#xD;
      psychiatric diagnoses.&#xD;
&#xD;
      The outcome prediction of relapse rate of a psychotic episode within a certain time frame is&#xD;
      difficult and depends on many factors. More and better predictors are required to improve the&#xD;
      outcome prediction in order to adjust therapy and follow-up if patients suffer from this&#xD;
      acute disease.&#xD;
&#xD;
      Copeptin, a surrogate marker for vasopressin, has been proven helpful in the prediction of&#xD;
      the outcome in serious somatic diseases. Additionally, a rise of copeptin due to&#xD;
      psychological stress was shown.&#xD;
&#xD;
      The aim of this study is to investigate the association of the neuroendocrine biomarker&#xD;
      copeptin and the prediction of the onset of psychotic episode within one year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An acute psychotic episode is a severe psychiatric syndrome characterised by symptoms like&#xD;
      delusions, hallucinations, and perceptual disturbances. A psychotic episode might occur in&#xD;
      different psychiatric diagnoses, such as schizophrenia spectrum disorders and affective&#xD;
      disorders (depression and bipolar).&#xD;
&#xD;
      The outcome prediction of relapse rate of a psychotic episode within a certain time frame is&#xD;
      difficult and depends on many factors. More and better predictors are required to improve the&#xD;
      outcome prediction in order to adjust therapy and follow-up if patients suffer from this&#xD;
      acute disease.&#xD;
&#xD;
      Copeptin, a surrogate marker for vasopressin, has been proven helpful in the prediction of&#xD;
      the outcome in serious somatic diseases such as stroke, myocardial infarction, and pneumonia.&#xD;
      Additionally, a rise of copeptin due to psychological stress was shown.&#xD;
&#xD;
      Some studies have shown an increase in vasopressin levels during acute psychosis, no study&#xD;
      has been performed using copeptin.&#xD;
&#xD;
      The aim of this study is to investigate the association of the neuroendocrine biomarker&#xD;
      copeptin and the prediction of the onset of psychotic episode within one year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">July 31, 2020</completion_date>
  <primary_completion_date type="Actual">July 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Copeptin level</measure>
    <time_frame>One year</time_frame>
    <description>Association of copeptin at inclusion with relapse rate of a psychotic episode within one year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in copeptin levels</measure>
    <time_frame>day 1 until day 30</time_frame>
    <description>Change in copeptin levels from day 1 until day 30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery of psychotic episode</measure>
    <time_frame>1 year</time_frame>
    <description>Time until recovery from the Initial psychotic Episode assessed after 30 days and one year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discharge from hospital</measure>
    <time_frame>one year</time_frame>
    <description>Time until discharge from hospital assessed after 30 days and one year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapy Response assessed by symptom reduction of &gt;30% in PANSS</measure>
    <time_frame>30 days</time_frame>
    <description>Therapy Response defined as symptom reduction of &gt;30% in PANSS assessed after 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapy Response measured by Global Assessment of Functioning (GAF) scale</measure>
    <time_frame>30 days</time_frame>
    <description>Therapy Response measured by Global Assessment of Functioning (GAF) scale assessed after 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of hyponatremia</measure>
    <time_frame>1 day</time_frame>
    <description>Incidence of hyponatremia during an acute psychotic episode assessed at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of primary polydipsia</measure>
    <time_frame>1 day</time_frame>
    <description>Incidence of primary polydipsia in patients with an acute psychotic episode assessed by reported amount of drinking at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of hospital re-admissions</measure>
    <time_frame>1 year</time_frame>
    <description>re-admission rate due to a psychotic episode observed over 1 year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>social function after 12 months (functioning) after 12 months assessed by questionnaire</measure>
    <time_frame>1 year</time_frame>
    <description>social function after 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of psychotic symptoms after 12 months compared to baseline assessed by questionnaire</measure>
    <time_frame>1 year</time_frame>
    <description>Severity of psychotic symptoms (functioning) after 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>psychological function (functioning) after 12 months compared to baseline assessed by questionnaire</measure>
    <time_frame>1 year</time_frame>
    <description>psychological function (functioning) after 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>operational function (functioning) after 12 months compared to baseline assessed by questionnaire</measure>
    <time_frame>1 year</time_frame>
    <description>operational function (functioning) after 12 months</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">73</enrollment>
  <condition>Acute Psychotic Episode</condition>
  <condition>Schizophrenia Spectrum and Other Psychotic Disorders</condition>
  <condition>Affective Disorder</condition>
  <condition>Bipolar Disorder</condition>
  <arm_group>
    <arm_group_label>Patients with an acute psychosis</arm_group_label>
    <description>Acute psychosis in schizophrenia spectrum disorder, affective disorder and bipolar disorder; Observation only</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation only</intervention_name>
    <description>Observation only</description>
    <arm_group_label>Patients with an acute psychosis</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Copeptin, Cortisol, Serum Sodium, Urinary sodium and urinary osmolality in case&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are hospitalized with an acute psychotic episode within schizophrenia spectrum&#xD;
        disorder, affective disorder and bipolar disorder.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-55 years&#xD;
&#xD;
          -  Acute psychotic episode&#xD;
&#xD;
          -  Informed consent as documented by signature&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Limited discernment due to psychiatric disorder to give informed consent&#xD;
&#xD;
          -  Acute psychotic Episode due to any organic reason&#xD;
&#xD;
          -  Psychotic Episode due to psychotropic substances&#xD;
&#xD;
          -  Severe somatic disease (acute myocardial infarction, acute sepsis, acute stroke)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mirjam Christ-Crain, MD-PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Basel, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>23824230</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>21289257</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>25472823</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>25249697</PMID>
  </results_reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>September 18, 2020</last_update_submitted>
  <last_update_submitted_qc>September 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Copeptin</keyword>
  <keyword>Outcome prediction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Insipidus</mesh_term>
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Mood Disorders</mesh_term>
    <mesh_term>Schizophrenia Spectrum and Other Psychotic Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03235908
org study id: 2016-02198
nct id: NCT03235908
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Copeptin level
time frame: One year
description: Association of copeptin at inclusion with relapse rate of a psychotic episode within one year
measure: Change in copeptin levels
time frame: day 1 until day 30
description: Change in copeptin levels from day 1 until day 30
measure: Recovery of psychotic episode
time frame: 1 year
description: Time until recovery from the Initial psychotic Episode assessed after 30 days and one year
measure: Discharge from hospital
time frame: one year
description: Time until discharge from hospital assessed after 30 days and one year
measure: Therapy Response assessed by symptom reduction of >30% in PANSS
time frame: 30 days
description: Therapy Response defined as symptom reduction of >30% in PANSS assessed after 30 days
measure: Therapy Response measured by Global Assessment of Functioning (GAF) scale
time frame: 30 days
description: Therapy Response measured by Global Assessment of Functioning (GAF) scale assessed after 30 days
measure: Occurence of hyponatremia
time frame: 1 day
description: Incidence of hyponatremia during an acute psychotic episode assessed at baseline
measure: Occurence of primary polydipsia
time frame: 1 day
description: Incidence of primary polydipsia in patients with an acute psychotic episode assessed by reported amount of drinking at baseline
measure: number of hospital re-admissions
time frame: 1 year
description: re-admission rate due to a psychotic episode observed over 1 year
measure: social function after 12 months (functioning) after 12 months assessed by questionnaire
time frame: 1 year
description: social function after 12 months
measure: Severity of psychotic symptoms after 12 months compared to baseline assessed by questionnaire
time frame: 1 year
description: Severity of psychotic symptoms (functioning) after 12 months
measure: psychological function (functioning) after 12 months compared to baseline assessed by questionnaire
time frame: 1 year
description: psychological function (functioning) after 12 months
measure: operational function (functioning) after 12 months compared to baseline assessed by questionnaire
time frame: 1 year
description: operational function (functioning) after 12 months
arm group label: Patients with an acute psychosis
description: Acute psychosis in schizophrenia spectrum disorder, affective disorder and bipolar disorder; Observation only
intervention type: Other
intervention name: Observation only
description: Observation only
arm group label: Patients with an acute psychosis
Copeptin, Cortisol, Serum Sodium, Urinary sodium and urinary osmolality in case
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Mirjam Christ-Crain, MD-PhD
role: Principal Investigator
affiliation: University Hospital, Basel, Switzerland
facility: 
country: Switzerland
citation: 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: 23824230
citation: 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: 21289257
citation: 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: 25472823
citation: 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: 25249697
responsible party type: Sponsor
mesh term: Diabetes Insipidus
mesh term: Schizophrenia
mesh term: Bipolar Disorder
mesh term: Mental Disorders
mesh term: Psychotic Disorders
mesh term: Mood Disorders
mesh term: Schizophrenia Spectrum and Other Psychotic Disorders
sharing ipd: Undecided