xml: <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/NCT06009523</url>
    </required_header>
    <id_info>
      <org_study_id>2022-A01454-39</org_study_id>
      <nct_id>NCT06009523</nct_id>
    </id_info>
    <brief_title>Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation</brief_title>
    <acronym>tDCS-IDSDEP</acronym>
    <official_title>Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation in Treatment-resistant Depression : a Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Henri Laborit</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Henri Laborit</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 demonstrate that 15 transcranial direct current&#xD;
        stimulation (tDCS) sessions of 30 minutes at 2 mA intensity are effective to reduce suicidal&#xD;
        ideation&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After being informed about the study and potential risks, all patients giving written&#xD;
        informed consent will undergo a screening visit to determine eligibility for study entry.&#xD;
        Patient who meet the eligibility requirements be able to start the 15 tDCS sessions at the&#xD;
        rate of one session per day. After the last session, patients will perform three follow-up&#xD;
        visits on D19, D49 and D79&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2026</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from Baseline in suicidal ideation on the Scale for Suicide Ideation (SSI) at &quot;Day 19&quot;</measure>
      <time_frame>Baseline and &quot;Day 19&quot;</time_frame>
      <description>The main judgment criterion is the evolution of suicidal ideation which is evaluated by the Beck Scale for Suicide Ideation (SSI) between Baseline and &quot;Day 19&quot;</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at &quot;Day 19&quot; post-tDCS sessions</measure>
      <time_frame>Baseline and &quot;Day 19&quot;</time_frame>
      <description>The Montgomery-Åsberg Depression Rating Scale (MADRS) was developed to provide an assay of depressive symptom severity for use in the investigation of treatment response to antidepressant medication. The MADRS takes 20-60 minutes to be completed by interview. MADRS-S has 9 items , and each item is scored between 0 (minimum) and 6 (maximum). The scores for all 9 items were added, and cutoff scores for the MADRS-S were defined for level of depression (depression: 0-12 = minimal, 13-19 = mild, 20-34 = moderate, ≥ 35 = severe).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at &quot;Day 49&quot; post-tDCS sessions</measure>
      <time_frame>Baseline and &quot;Day 49&quot;</time_frame>
      <description>The Montgomery-Åsberg Depression Rating Scale (MADRS) was developed to provide an assay of depressive symptom severity for use in the investigation of treatment response to antidepressant medication. The MADRS takes 20-60 minutes to be completed by interview. MADRS-S has 9 items , and each item is scored between 0 (minimum) and 6 (maximum). The scores for all 9 items were added, and cutoff scores for the MADRS-S were defined for level of depression (depression: 0-12 = minimal, 13-19 = mild, 20-34 = moderate, ≥ 35 = severe).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at &quot;Day 79&quot; post-tDCS sessions</measure>
      <time_frame>Baseline and &quot;Day 79&quot;</time_frame>
      <description>The Montgomery-Åsberg Depression Rating Scale (MADRS) was developed to provide an assay of depressive symptom severity for use in the investigation of treatment response to antidepressant medication. The MADRS takes 20-60 minutes to be completed by interview. MADRS-S has 9 items , and each item is scored between 0 (minimum) and 6 (maximum). The scores for all 9 items were added, and cutoff scores for the MADRS-S were defined for level of depression (depression: 0-12 = minimal, 13-19 = mild, 20-34 = moderate, ≥ 35 = severe).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in suicidal ideation assessed by the implicit association test at &quot;Day 19&quot; post-tDCS sessions</measure>
      <time_frame>Baseline and &quot;Day 19&quot;</time_frame>
      <description>The Implicit Association Test (IAT) is a computer-based test measuring implicit mental associations between two concepts. The IAT uses reaction times to categorize stimuli that appear in the middle of the screen into two target categories, in our study: &quot;Death&quot; (suicide, dies, funeral, lifeless, deceased) and &quot;Life&quot;. (survive, grow, breathe, alive, live) and/or in two attribute categories &quot;Me&quot; (me, myself, my, mine, I) and &quot;Not Me&quot; (them, they, their, his, others) . and subjects rapidly classify them by pressing one of two keys (the category of right (by pressing the I key) or left (by pressing the E key). According to the logic of the IAT, &quot;D positive&quot; scores represent a strong implicit association between &quot;Me&quot; and &quot;Death&quot;. We will use Greenwald's improved algorithm to analyze responses.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in suicidal ideation assessed by the implicit association test at &quot;Day 49&quot; post-tDCS sessions</measure>
      <time_frame>Baseline and &quot;Day 49&quot;</time_frame>
      <description>The Implicit Association Test (IAT) is a computer-based test measuring implicit mental associations between two concepts. The IAT uses reaction times to categorize stimuli that appear in the middle of the screen into two target categories, in our study: &quot;Death&quot; (suicide, dies, funeral, lifeless, deceased) and &quot;Life&quot;. (survive, grow, breathe, alive, live) and/or in two attribute categories &quot;Me&quot; (me, myself, my, mine, I) and &quot;Not Me&quot; (them, they, their, his, others) . and subjects rapidly classify them by pressing one of two keys (the category of right (by pressing the I key) or left (by pressing the E key). According to the logic of the IAT, &quot;D positive&quot; scores represent a strong implicit association between &quot;Me&quot; and &quot;Death&quot;. We will use Greenwald's improved algorithm to analyze responses.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in suicidal ideation assessed by the implicit association test at &quot;Day 79&quot; post-tDCS sessions</measure>
      <time_frame>Baseline and &quot;Day 79&quot;</time_frame>
      <description>The Implicit Association Test (IAT) is a computer-based test measuring implicit mental associations between two concepts. The IAT uses reaction times to categorize stimuli that appear in the middle of the screen into two target categories, in our study: &quot;Death&quot; (suicide, dies, funeral, lifeless, deceased) and &quot;Life&quot;. (survive, grow, breathe, alive, live) and/or in two attribute categories &quot;Me&quot; (me, myself, my, mine, I) and &quot;Not Me&quot; (them, they, their, his, others) . and subjects rapidly classify them by pressing one of two keys (the category of right (by pressing the I key) or left (by pressing the E key). According to the logic of the IAT, &quot;D positive&quot; scores represent a strong implicit association between &quot;Me&quot; and &quot;Death&quot;. We will use Greenwald's improved algorithm to analyze responses.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at &quot;Day 19&quot; post-tDCS sessions</measure>
      <time_frame>Baseline and &quot;Day 19&quot;</time_frame>
      <description>The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) is an indicator of overall health status. The SF-36 is validated and has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100, so that the lowest and highest possible scores are 0 and 100, respectively. Lower scores = more disability, higher scores = less disability. Sections : vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning, mental health.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at &quot;Day 49&quot; post-tDCS sessions</measure>
      <time_frame>Baseline and &quot;Day 49&quot;</time_frame>
      <description>The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) is an indicator of overall health status. The SF-36 is validated and has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100, so that the lowest and highest possible scores are 0 and 100, respectively. Lower scores = more disability, higher scores = less disability. Sections : vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning, mental health.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at &quot;Day 79&quot; post-tDCS sessions</measure>
      <time_frame>Baseline and &quot;Day 79&quot;</time_frame>
      <description>The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) is an indicator of overall health status. The SF-36 is validated and has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100, so that the lowest and highest possible scores are 0 and 100, respectively. Lower scores = more disability, higher scores = less disability. Sections : vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning, mental health.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Depression and Suicide</condition>
    <arm_group>
      <arm_group_label>Active tDCS</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants received an active tdcs: transcranial direct current with an intensity of 2 mA for 30 minutes</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcranial direct current stimulation</intervention_name>
      <description>1 stimulation per day during 15 days.</description>
      <arm_group_label>Active tDCS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age over 18 years&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
            -  Diagnosis of recurrent or isolated depressive episode according to DSM IV criteria&#xD;
               (A.P.A. 1994).&#xD;
  &#xD;
            -  Stable antidepressant treatment for 3 weeks&#xD;
  &#xD;
            -  MADRS score ≥ 20&#xD;
  &#xD;
            -  SSI score &gt; 3&#xD;
  &#xD;
            -  Subject affiliated to a health insurance system&#xD;
  &#xD;
            -  Woman with effective contraception and agreeing to maintain it throughout the study&#xD;
               period.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Depression with psychotic features Axis I (DSM IV) co-morbid diagnosis of&#xD;
               schizophrenia, alcohol and/or other substance dependence (or abuse) (lifetime)&#xD;
  &#xD;
            -  Patient who has already undergone an electroconvulsive therapy course for the current&#xD;
               episode and does not respond to this treatment&#xD;
  &#xD;
            -  Patient deprived of liberty&#xD;
  &#xD;
            -  Patient with high suicide risk (item 10 MADRS &gt; 4) in the absence of hospitalization&#xD;
  &#xD;
            -  Contraindication to tDCS: intracerebral metallic implant (with the exception of dental&#xD;
               implants), cardiac pacemaker, active or non-implanted devices in the region of the&#xD;
               head, acute eczema in the planned stimulation area&#xD;
  &#xD;
            -  Pregnant, parturient or breastfeeding woman&#xD;
  &#xD;
            -  Simultaneous participation in another interventional research&#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_contact>
      <last_name>Ghina Harika-Germaneau</last_name>
      <phone>05.16.52.61.18</phone>
      <email>ghina.harika-germaneau@ch-poitiers.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Centre Hospitalier Nord-Deux-Sèvres</name>
        <address>
          <city>Faye-l'abbesse</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Issa Wassouf</last_name>
        <email>wassouf.issa@chnds.fr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Centre Hospitalier Henri Laborit</name>
        <address>
          <city>Poitiers</city>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>tDCS</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
      <mesh_term>Suicide</mesh_term>
      <mesh_term>Suicidal Ideation</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06009523
  org study id: 2022-A01454-39
  nct id: NCT06009523
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The main objective of this study is to demonstrate that 15 transcranial direct current
        stimulation (tDCS) sessions of 30 minutes at 2 mA intensity are effective to reduce suicidal
        ideation
  After being informed about the study and potential risks, all patients giving written
        informed consent will undergo a screening visit to determine eligibility for study entry.
        Patient who meet the eligibility requirements be able to start the 15 tDCS sessions at the
        rate of one session per day. After the last session, patients will perform three follow-up
        visits on D19, D49 and D79
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change from Baseline in suicidal ideation on the Scale for Suicide Ideation (SSI) at "Day 19"
  time frame: Baseline and "Day 19"
  description: The main judgment criterion is the evolution of suicidal ideation which is evaluated by the Beck Scale for Suicide Ideation (SSI) between Baseline and "Day 19"
  measure: Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at "Day 19" post-tDCS sessions
  time frame: Baseline and "Day 19"
  description: The Montgomery-Åsberg Depression Rating Scale (MADRS) was developed to provide an assay of depressive symptom severity for use in the investigation of treatment response to antidepressant medication. The MADRS takes 20-60 minutes to be completed by interview. MADRS-S has 9 items , and each item is scored between 0 (minimum) and 6 (maximum). The scores for all 9 items were added, and cutoff scores for the MADRS-S were defined for level of depression (depression: 0-12 = minimal, 13-19 = mild, 20-34 = moderate, ≥ 35 = severe).
  measure: Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at "Day 49" post-tDCS sessions
  time frame: Baseline and "Day 49"
  description: The Montgomery-Åsberg Depression Rating Scale (MADRS) was developed to provide an assay of depressive symptom severity for use in the investigation of treatment response to antidepressant medication. The MADRS takes 20-60 minutes to be completed by interview. MADRS-S has 9 items , and each item is scored between 0 (minimum) and 6 (maximum). The scores for all 9 items were added, and cutoff scores for the MADRS-S were defined for level of depression (depression: 0-12 = minimal, 13-19 = mild, 20-34 = moderate, ≥ 35 = severe).
  measure: Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at "Day 79" post-tDCS sessions
  time frame: Baseline and "Day 79"
  description: The Montgomery-Åsberg Depression Rating Scale (MADRS) was developed to provide an assay of depressive symptom severity for use in the investigation of treatment response to antidepressant medication. The MADRS takes 20-60 minutes to be completed by interview. MADRS-S has 9 items , and each item is scored between 0 (minimum) and 6 (maximum). The scores for all 9 items were added, and cutoff scores for the MADRS-S were defined for level of depression (depression: 0-12 = minimal, 13-19 = mild, 20-34 = moderate, ≥ 35 = severe).
  measure: Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 19" post-tDCS sessions
  time frame: Baseline and "Day 19"
  description: The Implicit Association Test (IAT) is a computer-based test measuring implicit mental associations between two concepts. The IAT uses reaction times to categorize stimuli that appear in the middle of the screen into two target categories, in our study: "Death" (suicide, dies, funeral, lifeless, deceased) and "Life". (survive, grow, breathe, alive, live) and/or in two attribute categories "Me" (me, myself, my, mine, I) and "Not Me" (them, they, their, his, others) . and subjects rapidly classify them by pressing one of two keys (the category of right (by pressing the I key) or left (by pressing the E key). According to the logic of the IAT, "D positive" scores represent a strong implicit association between "Me" and "Death". We will use Greenwald's improved algorithm to analyze responses.
  measure: Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 49" post-tDCS sessions
  time frame: Baseline and "Day 49"
  description: The Implicit Association Test (IAT) is a computer-based test measuring implicit mental associations between two concepts. The IAT uses reaction times to categorize stimuli that appear in the middle of the screen into two target categories, in our study: "Death" (suicide, dies, funeral, lifeless, deceased) and "Life". (survive, grow, breathe, alive, live) and/or in two attribute categories "Me" (me, myself, my, mine, I) and "Not Me" (them, they, their, his, others) . and subjects rapidly classify them by pressing one of two keys (the category of right (by pressing the I key) or left (by pressing the E key). According to the logic of the IAT, "D positive" scores represent a strong implicit association between "Me" and "Death". We will use Greenwald's improved algorithm to analyze responses.
  measure: Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 79" post-tDCS sessions
  time frame: Baseline and "Day 79"
  description: The Implicit Association Test (IAT) is a computer-based test measuring implicit mental associations between two concepts. The IAT uses reaction times to categorize stimuli that appear in the middle of the screen into two target categories, in our study: "Death" (suicide, dies, funeral, lifeless, deceased) and "Life". (survive, grow, breathe, alive, live) and/or in two attribute categories "Me" (me, myself, my, mine, I) and "Not Me" (them, they, their, his, others) . and subjects rapidly classify them by pressing one of two keys (the category of right (by pressing the I key) or left (by pressing the E key). According to the logic of the IAT, "D positive" scores represent a strong implicit association between "Me" and "Death". We will use Greenwald's improved algorithm to analyze responses.
  measure: Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at "Day 19" post-tDCS sessions
  time frame: Baseline and "Day 19"
  description: The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) is an indicator of overall health status. The SF-36 is validated and has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100, so that the lowest and highest possible scores are 0 and 100, respectively. Lower scores = more disability, higher scores = less disability. Sections : vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning, mental health.
  measure: Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at "Day 49" post-tDCS sessions
  time frame: Baseline and "Day 49"
  description: The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) is an indicator of overall health status. The SF-36 is validated and has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100, so that the lowest and highest possible scores are 0 and 100, respectively. Lower scores = more disability, higher scores = less disability. Sections : vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning, mental health.
  measure: Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at "Day 79" post-tDCS sessions
  time frame: Baseline and "Day 79"
  description: The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) is an indicator of overall health status. The SF-36 is validated and has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100, so that the lowest and highest possible scores are 0 and 100, respectively. Lower scores = more disability, higher scores = less disability. Sections : vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning, mental health.
  arm group label: Active tDCS
  arm group type: Experimental
  description: Participants received an active tdcs: transcranial direct current with an intensity of 2 mA for 30 minutes
  intervention type: Device
  intervention name: Transcranial direct current stimulation
  description: 1 stimulation per day during 15 days.
  arm group label: Active tDCS
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ghina Harika-Germaneau
  phone: 05.16.52.61.18
  email: ghina.harika-germaneau@ch-poitiers.fr
  facility: 
  contact: 
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Depression
  mesh term: Suicide
  mesh term: Suicidal Ideation