<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/NCT03026387</url>
  </required_header>
  <id_info>
    <org_study_id>UF 9681</org_study_id>
    <secondary_id>2016-A00845-46</secondary_id>
    <nct_id>NCT03026387</nct_id>
  </id_info>
  <brief_title>Evaluation of the Risk Associated With Impulsivity and Other Neuropsychological Factors on Suicidal Relapse Within Hospital Emergencies</brief_title>
  <acronym>SUI-PREDICT</acronym>
  <official_title>Evaluation of the Risk Associated With Impulsivity and Other Neuropsychological Factors on Suicidal Relapse Within Hospital Emergencies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Health and Medical Research 1061, Montpellier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Suicidal behavior (SB) is a major public health problem in France, with over 10,000 suicides&#xD;
      (6th in the EU28) and 220,000 suicide attempts (SA) per year. These data seem underestimated&#xD;
      by 20%. A large percentage of men (6%) and women (9%) in France made at least one lifetime&#xD;
      SA. In addition, SBs are common among young people and are the second leading cause of death&#xD;
      among 15-44 year-olds. The interaction of multiple factors in SB complicates the creation of&#xD;
      predictive models. These are currently imprecise and prevent the development of consensual&#xD;
      recommendations for the management of suicidal patients.&#xD;
&#xD;
      Most suicide attempters are evaluated in the emergency room where it is imperative to&#xD;
      identify people with a high risk of relapse. Risk assessment is generally based on the&#xD;
      experience of the practitioner who uses psychometric scales as support for clinical&#xD;
      decisions. This assessment could be improved and supplemented by other sources of&#xD;
      information. Thus, we aim to develop a short and specific tool that combines:&#xD;
&#xD;
        1. Neurocognitive measures carried out using computer software on domains strongly&#xD;
           associated with SB: impulsivity, affective dysregulation, alterations in decision-making&#xD;
           (risky choices), selective attention and verbal fluency.&#xD;
&#xD;
        2. Clinical and psychological assessment including the most predictive items of future SA:&#xD;
           life events (environment) and personality traits (vulnerability). Suicide attempters&#xD;
           will be assessed for SB and suicidal ideation in the emergency department. These&#xD;
           measures will be repeated during a 12-month follow-up. We will use the data obtained to&#xD;
           provide a more accurate measure of risk.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over 65 months, 5 emergency departments (Montpellier, Nimes, Uzès, Nice, Marseille) will&#xD;
      recruit a total of 650 patients who attempted suicide.&#xD;
&#xD;
        -  First visit: clinical and neuropsychological assessment&#xD;
&#xD;
        -  Second and third visits at 6 and 12 months: assessment of SBs and suicidal relapse,&#xD;
           clinical and neuropsychological assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 5, 2017</start_date>
  <completion_date type="Anticipated">October 2024</completion_date>
  <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of suicidal relapse according to aggressive impulsivity.</measure>
    <time_frame>12 months</time_frame>
    <description>aggressive impulsivity will be assessed by the capacity to inhibit responses during a Continuous Performance Task (CPT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Score of a short scale of suicidal risk assessment</measure>
    <time_frame>12 months</time_frame>
    <description>We aim to identify predictive factors of the occurrence of suicidal behavior in a non-psychotic suicidal population, in order to develop a battery of short-term tests applicable to emergencies. This short term tests will allow to establish a multidimensional score for the prediction of the risk of relapse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of suicidal ideation assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>12 months</time_frame>
    <description>We aim to identify predictive factors of the occurrence of suicidal behavior in a non-psychotic suicidal population, in order to develop a battery of short-term tests applicable to emergencies. This short term tests will allow to establish a multidimensional score for the prediction of the risk of relapse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of suicidal behaviors assessed by Columbia Suicide History Form and the Columbia Suicide Severity Rating Scale</measure>
    <time_frame>12 months</time_frame>
    <description>We aim to identify predictive factors of the occurrence of suicidal behavior in a non-psychotic suicidal population, in order to develop a battery of short-term tests applicable to emergencies. This short term tests will allow to establish a multidimensional score for the prediction of the risk of relapse</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">650</enrollment>
  <condition>Suicide Attempt</condition>
  <arm_group>
    <arm_group_label>Neuropsychological battery tests</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All participants performed the same evaluation: clinical and neuropsychological assessment.&#xD;
All of them are suicide attempters without psychotic features</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Neuropsychological battery tests</intervention_name>
    <description>The neuropsychological battery tests is composed with: Continuous Performance Test, Iowa Gambling Test, Verbal fluency (animals), Emotional stroop, Self-injury implicit association test and N-back test.&#xD;
The neuropsychological battery assesses domains heavily involved in suicidal behavior: impulsivity, affective dysregulation, alterations in decision-making (risky choices), selective attention,verbal fluidity and working memory.</description>
    <arm_group_label>Neuropsychological battery tests</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being at least 18 years old&#xD;
&#xD;
          -  Have committed a suicide attempt within 7 days prior to inclusion&#xD;
&#xD;
          -  Receive minimal treatment (assessed by the clinician)&#xD;
&#xD;
          -  Sign the informed consent&#xD;
&#xD;
          -  Be able to understand the nature, the aims and the methodology of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with an actual or past history of psychotic disorder&#xD;
&#xD;
          -  Patient not affiliated to a French social security system.&#xD;
&#xD;
          -  Patient deprived of liberty (judicial or administrative decision)&#xD;
&#xD;
          -  Patient aged 65 years or older with an MMSE score &lt;24 at baseline.&#xD;
&#xD;
          -  Patient in exclusion period after participation in another project&#xD;
&#xD;
          -  Patient who has already achieved 4500€ of annual research allowances&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jorge LOPEZ-CASTROMAN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Nīmes</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jorge LOPEZ-CASTROMAN, MD</last_name>
    <phone>+33 4 66 68 34 26</phone>
    <email>jorge.lopezcastroman@chu-nimes.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Montpellier University Hospital</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine GENTY, MD</last_name>
      <phone>+33 4 67 99 61 45 75</phone>
      <email>c-genty@chu-montpellier.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>September 26, 2022</last_update_submitted>
  <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Suicidal behavior</keyword>
  <keyword>Suicide attempt</keyword>
  <keyword>Emergency department</keyword>
  <keyword>Psychometrics</keyword>
  <keyword>Neuropsychological tests</keyword>
  <keyword>Suicidal ideation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Suicide</mesh_term>
    <mesh_term>Impulsive Behavior</mesh_term>
    <mesh_term>Suicide, Attempted</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03026387
org study id: UF 9681
secondary id: 2016-A00845-46
nct id: NCT03026387
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Suicidal behavior (SB) is a major public health problem in France, with over 10,000 suicides
      (6th in the EU28) and 220,000 suicide attempts (SA) per year. These data seem underestimated
      by 20%. A large percentage of men (6%) and women (9%) in France made at least one lifetime
      SA. In addition, SBs are common among young people and are the second leading cause of death
      among 15-44 year-olds. The interaction of multiple factors in SB complicates the creation of
      predictive models. These are currently imprecise and prevent the development of consensual
      recommendations for the management of suicidal patients.

      Most suicide attempters are evaluated in the emergency room where it is imperative to
      identify people with a high risk of relapse. Risk assessment is generally based on the
      experience of the practitioner who uses psychometric scales as support for clinical
      decisions. This assessment could be improved and supplemented by other sources of
      information. Thus, we aim to develop a short and specific tool that combines:

        1. Neurocognitive measures carried out using computer software on domains strongly
           associated with SB: impulsivity, affective dysregulation, alterations in decision-making
           (risky choices), selective attention and verbal fluency.

        2. Clinical and psychological assessment including the most predictive items of future SA:
           life events (environment) and personality traits (vulnerability). Suicide attempters
           will be assessed for SB and suicidal ideation in the emergency department. These
           measures will be repeated during a 12-month follow-up. We will use the data obtained to
           provide a more accurate measure of risk.
Over 65 months, 5 emergency departments (Montpellier, Nimes, Uzès, Nice, Marseille) will
      recruit a total of 650 patients who attempted suicide.

        -  First visit: clinical and neuropsychological assessment

        -  Second and third visits at 6 and 12 months: assessment of SBs and suicidal relapse,
           clinical and neuropsychological assessment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Frequency of suicidal relapse according to aggressive impulsivity.
time frame: 12 months
description: aggressive impulsivity will be assessed by the capacity to inhibit responses during a Continuous Performance Task (CPT)
measure: Score of a short scale of suicidal risk assessment
time frame: 12 months
description: We aim to identify predictive factors of the occurrence of suicidal behavior in a non-psychotic suicidal population, in order to develop a battery of short-term tests applicable to emergencies. This short term tests will allow to establish a multidimensional score for the prediction of the risk of relapse.
measure: Intensity of suicidal ideation assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: 12 months
description: We aim to identify predictive factors of the occurrence of suicidal behavior in a non-psychotic suicidal population, in order to develop a battery of short-term tests applicable to emergencies. This short term tests will allow to establish a multidimensional score for the prediction of the risk of relapse
measure: Characteristics of suicidal behaviors assessed by Columbia Suicide History Form and the Columbia Suicide Severity Rating Scale
time frame: 12 months
description: We aim to identify predictive factors of the occurrence of suicidal behavior in a non-psychotic suicidal population, in order to develop a battery of short-term tests applicable to emergencies. This short term tests will allow to establish a multidimensional score for the prediction of the risk of relapse
arm group label: Neuropsychological battery tests
arm group type: Other
description: All participants performed the same evaluation: clinical and neuropsychological assessment.
All of them are suicide attempters without psychotic features
intervention type: Behavioral
intervention name: Neuropsychological battery tests
description: The neuropsychological battery tests is composed with: Continuous Performance Test, Iowa Gambling Test, Verbal fluency (animals), Emotional stroop, Self-injury implicit association test and N-back test.
The neuropsychological battery assesses domains heavily involved in suicidal behavior: impulsivity, affective dysregulation, alterations in decision-making (risky choices), selective attention,verbal fluidity and working memory.
arm group label: Neuropsychological battery tests
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jorge LOPEZ-CASTROMAN, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Nīmes
last name: Jorge LOPEZ-CASTROMAN, MD
phone: +33 4 66 68 34 26
email: jorge.lopezcastroman@chu-nimes.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Suicide
mesh term: Impulsive Behavior
mesh term: Suicide, Attempted
sharing ipd: No