<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/NCT03230448</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/17-0074</org_study_id>
    <secondary_id>2017-A00641-52</secondary_id>
    <nct_id>NCT03230448</nct_id>
  </id_info>
  <brief_title>Study of the Links Between Suicidal Intentionality and Acute Alcoholism</brief_title>
  <acronym>ISA</acronym>
  <official_title>Study of the Links Between Suicidal Intentionality and Acute Alcoholism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</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>
      There is a strong link between the alcohol consumption and the suicidal risk. Indeed there is&#xD;
      an increase of the risk of suicide in case of chronic or acute alcohol consumption. However&#xD;
      why the alcohol consumption increase the suicidal risk is unknown.&#xD;
&#xD;
      The hypothesis of this study is that the alcohol consumption induced disinhibition and&#xD;
      facilitates the suicide attempt without premeditation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      People hospitalized after a suicide attempt will answer to two questionnaires about the&#xD;
      suicide intentionality and the acute alcohol consumption.&#xD;
&#xD;
      There is 2 arms:&#xD;
&#xD;
      people doing suicide attempt and with positive level of alcohol (up to 0.1g.L) people doing&#xD;
      suicide attempt and with negative level of alcohol&#xD;
&#xD;
      110 patients will be included in this study so 55 in each arm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 29, 2017</start_date>
  <completion_date type="Actual">July 31, 2017</completion_date>
  <primary_completion_date type="Actual">July 31, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>compare the score of suicidal intentionality in patient presenting a positive or a negative alcohol level and doing suicide attempt</measure>
    <time_frame>15 minutes</time_frame>
    <description>patient will complete the PIERCE questionnaire about the suicidal intentionality</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">110</enrollment>
  <condition>Suicide, Attempted</condition>
  <arm_group>
    <arm_group_label>positive alcoholism</arm_group_label>
    <description>positive acute alcoholism had questionnaire about suicidal intentionality</description>
  </arm_group>
  <arm_group>
    <arm_group_label>negative alcoholism</arm_group_label>
    <description>negative acute alcoholism had questionnaire about suicidal intentionality</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire</intervention_name>
    <description>after the inclusion patient will answer to a questionnaire about the suicidal intentionality and a second about the alcool consumption</description>
    <arm_group_label>negative alcoholism</arm_group_label>
    <arm_group_label>positive alcoholism</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        people hospitalized in the emergency department after a suicide attempt by voluntary drug&#xD;
        intoxication&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient hospitalized in emergency department for a suicide attempt by voluntary drug&#xD;
             intoxication&#xD;
&#xD;
          -  speaking and understanding french&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who has used other psychoactive substances (attested by toxicological analyzes&#xD;
             and / or interrogation)&#xD;
&#xD;
          -  Known neurodegenerative pathology&#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>Juliette SALLES, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute alcoholism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Suicide</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/NCT03230448
org study id: RC31/17-0074
secondary id: 2017-A00641-52
nct id: NCT03230448
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is a strong link between the alcohol consumption and the suicidal risk. Indeed there is
      an increase of the risk of suicide in case of chronic or acute alcohol consumption. However
      why the alcohol consumption increase the suicidal risk is unknown.

      The hypothesis of this study is that the alcohol consumption induced disinhibition and
      facilitates the suicide attempt without premeditation
People hospitalized after a suicide attempt will answer to two questionnaires about the
      suicide intentionality and the acute alcohol consumption.

      There is 2 arms:

      people doing suicide attempt and with positive level of alcohol (up to 0.1g.L) people doing
      suicide attempt and with negative level of alcohol

      110 patients will be included in this study so 55 in each arm.
observational model: Other
time perspective: Prospective
measure: compare the score of suicidal intentionality in patient presenting a positive or a negative alcohol level and doing suicide attempt
time frame: 15 minutes
description: patient will complete the PIERCE questionnaire about the suicidal intentionality
arm group label: positive alcoholism
description: positive acute alcoholism had questionnaire about suicidal intentionality
arm group label: negative alcoholism
description: negative acute alcoholism had questionnaire about suicidal intentionality
intervention type: Other
intervention name: questionnaire
description: after the inclusion patient will answer to a questionnaire about the suicidal intentionality and a second about the alcool consumption
arm group label: negative alcoholism
arm group label: positive alcoholism
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Juliette SALLES, MD
role: Principal Investigator
affiliation: University Hospital of Toulouse
facility: 
country: France
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Suicide
mesh term: Suicide, Attempted
sharing ipd: No