<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/NCT03287986</url>
  </required_header>
  <id_info>
    <org_study_id>LOCAL/2016/FJMW-01</org_study_id>
    <nct_id>NCT03287986</nct_id>
  </id_info>
  <brief_title>Brain Markers of Suicide Risk and Psychological Pain in Elderly Depressed Patients</brief_title>
  <acronym>SPAD-IRM</acronym>
  <official_title>Brain Markers of Suicide Risk and Psychological Pain in Elderly Depressed Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nīmes</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>
      The main objective of this study is to show MRI functional and structural differences between&#xD;
      depressed elderly patients with a history of attempted suicide compared to depressed elderly&#xD;
      patients with no history of attempted suicide and to elderly subjects with no personal&#xD;
      history of depression or attempted suicide (healthy controls).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 18, 2017</start_date>
  <completion_date type="Actual">December 13, 2019</completion_date>
  <primary_completion_date type="Actual">December 13, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Brain functional activity during unfairness</measure>
    <time_frame>Day 0</time_frame>
    <description>Contrast in BOLD signal measured by 3T-Magnetic Resonance Imaging (MRI) during the fair vs unfair trials of the Ultimatum Game</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brain structural volumes</measure>
    <time_frame>Day 0</time_frame>
    <description>T1 sequence measured by MRI in each participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain structural connectivity</measure>
    <time_frame>Day 0</time_frame>
    <description>Diffusion Tensor Imaging measured by MRI in each participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain functional connectivity</measure>
    <time_frame>Day 0</time_frame>
    <description>Resting state activity measured by MRI in each participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of MRI measures with psychological pain measures</measure>
    <time_frame>Day 0</time_frame>
    <description>Psychological pain will be measured by the Visual Analog Scale (Olié et al. 2010) in each participant</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Depressive Disorder</condition>
  <condition>Suicide, Attempted</condition>
  <arm_group>
    <arm_group_label>Suicide attempters</arm_group_label>
    <description>Depressed patients over 60 years of age with a personal history of suicide attempts scanned with MRI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient controls</arm_group_label>
    <description>depressed patients over 60 years of age without a personal history of suicide attempt scanned with MRI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <description>Healthy subjects over 60 years, not depressed and without personal history of severe mental illness or suicide attempts, scanned with MRI</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>Structural and functional sequences</description>
    <arm_group_label>Healthy Controls</arm_group_label>
    <arm_group_label>Patient controls</arm_group_label>
    <arm_group_label>Suicide attempters</arm_group_label>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      DNA, blood.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Elderly depressed patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient must have given their free and informed consent and signed the consent&#xD;
             form&#xD;
&#xD;
          -  be a member or beneficiary of a health insurance plan&#xD;
&#xD;
          -  aged 60 years-old or more&#xD;
&#xD;
          -  must be right-handed&#xD;
&#xD;
          -  with a diagnosis of a current major depressive episode of moderate to severe severity&#xD;
             according to diagnostic criteria.&#xD;
&#xD;
          -  with or without a personal history of attempted suicide during life&#xD;
&#xD;
          -  hospitalized or followed by a consultant in the department of Psychiatry of Nîmes&#xD;
             University Hospital or in the Sophoras private clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject is participating in an interventional study, or is in a period of&#xD;
             exclusion determined by a previous study&#xD;
&#xD;
          -  under safeguard of justice&#xD;
&#xD;
          -  refuses to sign the consent&#xD;
&#xD;
          -  It is impossible to give the subject informed information&#xD;
&#xD;
          -  Current psychotic symptoms.&#xD;
&#xD;
          -  Bipolar disorder.&#xD;
&#xD;
          -  The subject presents an acute somatic decompensation incompatible with the realization&#xD;
             of this study.&#xD;
&#xD;
          -  The patient presents a mental confusion or a known Mini Mental State Examination score&#xD;
             &lt;24.&#xD;
&#xD;
          -  Central neurological disease known in particular degenerative pathology, severe&#xD;
             cranial trauma and severe cerebrovascular disease.&#xD;
&#xD;
          -  Schizophrenia and other known psychotic disorders.&#xD;
&#xD;
          -  Electroconvulsive therapy in the 12 months prior to study&#xD;
&#xD;
          -  Inability to perform neuropsychological tests because of a language problem, poor&#xD;
             understanding, a major tremor, inability to sit still, a major sight problem that&#xD;
             cannot be corrected, or other severe cognitive impairment&#xD;
&#xD;
          -  Contra-indication to magnetic resonance imaging (MRI): ferromagnetic implant in the&#xD;
             body, piercing, claustrophobia, inability to remain elongated for 45 minutes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fabrice Jollant, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Nîmes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Nimes</name>
      <address>
        <city>Nîmes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>April 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>March 6, 2020</last_update_submitted>
  <last_update_submitted_qc>March 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Elderly</keyword>
  <keyword>MRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</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/NCT03287986
org study id: LOCAL/2016/FJMW-01
nct id: NCT03287986
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of this study is to show MRI functional and structural differences between
      depressed elderly patients with a history of attempted suicide compared to depressed elderly
      patients with no history of attempted suicide and to elderly subjects with no personal
      history of depression or attempted suicide (healthy controls).
observational model: Case-Control
time perspective: Cross-Sectional
measure: Brain functional activity during unfairness
time frame: Day 0
description: Contrast in BOLD signal measured by 3T-Magnetic Resonance Imaging (MRI) during the fair vs unfair trials of the Ultimatum Game
measure: Brain structural volumes
time frame: Day 0
description: T1 sequence measured by MRI in each participant
measure: Brain structural connectivity
time frame: Day 0
description: Diffusion Tensor Imaging measured by MRI in each participant
measure: Brain functional connectivity
time frame: Day 0
description: Resting state activity measured by MRI in each participant
measure: Correlation of MRI measures with psychological pain measures
time frame: Day 0
description: Psychological pain will be measured by the Visual Analog Scale (Olié et al. 2010) in each participant
arm group label: Suicide attempters
description: Depressed patients over 60 years of age with a personal history of suicide attempts scanned with MRI
arm group label: Patient controls
description: depressed patients over 60 years of age without a personal history of suicide attempt scanned with MRI
arm group label: Healthy Controls
description: Healthy subjects over 60 years, not depressed and without personal history of severe mental illness or suicide attempts, scanned with MRI
intervention type: Other
intervention name: MRI
description: Structural and functional sequences
arm group label: Healthy Controls
arm group label: Patient controls
arm group label: Suicide attempters
DNA, blood.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Fabrice Jollant, MD PhD
role: Principal Investigator
affiliation: CHU Nîmes
facility: 
country: France
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Suicide
mesh term: Suicide, Attempted
sharing ipd: No