<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/NCT03758105</url>
  </required_header>
  <id_info>
    <org_study_id>RC17_0493</org_study_id>
    <nct_id>NCT03758105</nct_id>
  </id_info>
  <brief_title>Transcranial Direct Current Stimulation (tDCS) Cost-utility-analysis in Medical Care on Depressive Episode With One Drug Therapy Failure.</brief_title>
  <acronym>DISCO</acronym>
  <official_title>Transcranial Direct Current Stimulation (tDCS) Cost-utility-analysis in Medical Care on Depressive Episode With One Drug Therapy Failure.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</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 purpose of this study is to determine the transcranial direct current stimulation (tDCS)&#xD;
      cost-utility in the depression therapy.&#xD;
&#xD;
      This is a 3 years medico-economics study with 1 year follow-up period involving patients with&#xD;
      1 or 2 depression treatment(s) failed.&#xD;
&#xD;
      Eligible subject will be randomized in 2 groups, usual care with tDCS cure (arm A) or only&#xD;
      usual care (arm B).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Transcranial direct current stimulation is a non-invasive brain neuromodulation technique.&#xD;
      tDCS can be a new therapy in depression.&#xD;
&#xD;
      This study focuses on tDCS cost-utility-analysis. Each patient is following during 12 months.&#xD;
      Patients are randomized in 2 arms. Arm A usual care with tDCS cure or arm B usual care&#xD;
      without tDCS.&#xD;
&#xD;
      Patient in arm A get a initial tDCS cure one week after randomization. If these patients are&#xD;
      answering to the treatment, they can have a new cure in case of relapse. This new cure can&#xD;
      start from the second month following initial treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Anticipated">November 11, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 11, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cost-utility ratio, according to collective perspective of tDCS use in depression compared to usual care without active tDCS.</measure>
    <time_frame>12 months</time_frame>
    <description>The utility will be measured by :&#xD;
Quality Adjusted Life Year (QALYs) as estimated from responses to the Euroqol-5 Dimensions (EQ-5D) health-related quality of life questionnaire. The questionnaire focuses on 5 dimensions: mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression. For each of these dimensions, 5 answers are possible.&#xD;
The costs will be measured by the addition of the following costs:&#xD;
Drugs dispensing via Health insurance database &quot;National system of information of the French health insurance&quot; (SNIIRAM), hospitalizations, work stoppages and care consumption collected in a declarative patient questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Budget impact analysis of spreading the most efficient strategy for using tDCS</measure>
    <time_frame>5 years</time_frame>
    <description>Comparison of intervention costs on the study sample and projection of these costs over 5 years, from the health insurance and hospital perspectives</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate</measure>
    <time_frame>at baseline, at the end of each tDCS cure (for Arm A patients) through study completion (12 months) and at 12 months for all patients</time_frame>
    <description>Response is defined as follows: decrease of the MADRS score by at least 50% compared to baseline score. MADRS stands for Montgomery-Asberg Depression Rating Scale. It is used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. A score from 0 to 6 being normal/symptom absent and a score &gt;34 being severe depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission rate</measure>
    <time_frame>12 months</time_frame>
    <description>Remission rate is defined as follows: MADRS score &lt; 10 (see detailed description of MADRS in outcome 3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse-free survival</measure>
    <time_frame>12 months</time_frame>
    <description>Number of patients with no relapse. Relapse is defined as follows: MADRS ≥ 20 (see detailed description of MADRS in outcome 3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MADRS score</measure>
    <time_frame>At Baseline, one month, 2 months, 6 months and 12 months.</time_frame>
    <description>MADRS score (see detailed description of MADRS in outcome 3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory (BDI) score</measure>
    <time_frame>At Baseline, one month, 2 months, 6 months and 12 months.</time_frame>
    <description>The BDI is 13-item multiple-choice self-report inventory, for measuring the severity of depression. The global score is an addition of each item's score and ranges from 0 (minimal depression) to 39 (severe depression).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression (CGI) score</measure>
    <time_frame>At Baseline, one month, 2 months, 6 months and 12 months.</time_frame>
    <description>The Clinical Global Impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. Each scale is rated from 0 to 7. 0 being the best level and 7 the worst level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MOCA Score (Montreal Cognitive Assessment)</measure>
    <time_frame>At Baseline, one month, 2 months, 6 months and 12 months.</time_frame>
    <description>Thirty items assessing multiple cognitive domains are contained in the MoCA: short-term memory (5 points); visuospatial abilities via clock drawing (3 points), and a cube copy task (1 point); executive functioning via an adaptation of Trail Making Test Part B (1 point), phonemic fluency (1 point), and verbal abstraction (2 points); attention, concentration, and working memory via target detection (1 point), serial subtraction (3 points), digits forward (1 point), and digits backward (1 point); language via confrontation naming with low-familiarity animals (3 points), and repetition of complex sentences (2 points); and orientation to time and place (6 points)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events linked to the medical treatment for depression</measure>
    <time_frame>12 months</time_frame>
    <description>Number and types of adverse events linked to the medical treatment for depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of suicide attempts</measure>
    <time_frame>12 months</time_frame>
    <description>number of suicide attempts per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of suicides</measure>
    <time_frame>12 months</time_frame>
    <description>number of suicides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment(s) switch(es)</measure>
    <time_frame>At Baseline, one month, 2 months, 6 months and 12 months.</time_frame>
    <description>Number of treatment switches per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment(s) dose increase</measure>
    <time_frame>At Baseline, one month, 2 months, 6 months and 12 months.</time_frame>
    <description>Number of drug(s) dose(s) increases prescribed to the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatments combination(s)</measure>
    <time_frame>at Baseline, one month, 2 months, 6 months and 12 months.</time_frame>
    <description>List of drugs (name) prescribed to the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Declarative drug compliance via the MARS (Medication Adherence Report Scale)</measure>
    <time_frame>at baseline and at 12 months</time_frame>
    <description>MARS is the Medication Adherence Report Scale, including 10 questions, the global score ranges from 0 to 10, 0 corresponds to the worst drug compliance and 10 to an excellent drug compliance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Declarative drug compliance via the CRS (Clinician Rating Scale)</measure>
    <time_frame>at baseline and at 12 months</time_frame>
    <description>CRS is the Clinician Rating Scale , including 7 questions, the global score ranges from 1 to 7, 7 being the worst level of drug compliance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of tDCS sessions</measure>
    <time_frame>12 months</time_frame>
    <description>total number of tDCS sessions per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days between the successive tDCS cures</measure>
    <time_frame>12 months</time_frame>
    <description>Number of days between end of tDCS cure X and beginning of cure X+1, for each patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events linked to tDCS</measure>
    <time_frame>12 months</time_frame>
    <description>Number and types of adverse events linked to the tDCS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance with tDCS</measure>
    <time_frame>12 months</time_frame>
    <description>number of missed sessions over the number of planned sessions, per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient acceptability of the tDCS technique: Analog Visual Scale</measure>
    <time_frame>at the end of the first tDCS cure (up to one month)</time_frame>
    <description>Analog Visual Scale of acceptability of the tDCS completed by the patient, ranging from 0 to 10. 0 being &quot;not acceptable&quot; and 10 being &quot;totally acceptable&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>professional status</measure>
    <time_frame>At baseline</time_frame>
    <description>patient's professional status (active, unemployed, retired...)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of the implementation of the tDCS on the organization of care</measure>
    <time_frame>12 months</time_frame>
    <description>The organizational impact of the tDCS will be evaluated from the point of view of doctors, nurse and patients: staff, equipment, maintenance, location and mobilization time of these resources, using a specific questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">214</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Usual care and tDCS (Arm A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm A patient receives a first tDCS treatment in association with usual care (medication, psychotherapy...). If the patient is responding to tDCS, he can have other tDCS treatments in case of relapse.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care without tDCS (Arm B)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm B patient receives usual care: medication management and psychotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>tDCS associated with usual care</intervention_name>
    <description>A tDCS cure will be given to the group &quot;tDCS&quot;, one week after their randomization.&#xD;
This will be done in association with usual care: medication and psychotherapy Parameters: Anodal stimulation on dorso-lateral prefrontal cortex left, 2mA current.&#xD;
Treatment will consist of 15 days with 30 minutes stimulation per day, 5 days a week for 3 weeks.</description>
    <arm_group_label>Usual care and tDCS (Arm A)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Medication and psychotherapy as prescribed in usual care</description>
    <arm_group_label>Usual care without tDCS (Arm B)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Depression according to Diagnostic and Statistical Manual of Mental Disorders, Fifth&#xD;
             Edition (DSM-V) with 1 or 2 failed antidepressant treatments for the current episode.&#xD;
&#xD;
          -  MADRS score superior or equal to 15.&#xD;
&#xD;
          -  Patient agreeing to participate in the study&#xD;
&#xD;
          -  Patient able to answer questionnaires and able to go at research center for follow-up&#xD;
             visit.&#xD;
&#xD;
          -  Patient with social insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Electroconvulsive therapy or repetitive transcranial magnetic stimulation for current&#xD;
             depressive episode.&#xD;
&#xD;
          -  Depressive episode with psychotic symptoms or mixed.&#xD;
&#xD;
          -  Schizophrenia or addiction to another substance than nicotine&#xD;
&#xD;
          -  Severe neurological disorder (like epilepsy, neurological affect, neurological&#xD;
             disease)&#xD;
&#xD;
          -  Severe and / or progressive somatic pathology (leave to the investigator judgment)&#xD;
             preventing from participation in the study.&#xD;
&#xD;
          -  tDCS specific contraindications (intracerebral metallic implant, pacemaker)&#xD;
&#xD;
          -  Pregnancy or breast feeding.&#xD;
&#xD;
          -  Woman of childbearing age without contraception (hormonal or with medical device).&#xD;
&#xD;
          -  Participation in another interventional clinical trial&#xD;
&#xD;
          -  legal protection&#xD;
&#xD;
          -  Persons incarcerated or in obligation of treatment / medical treatment order.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU d'Angers</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Mirambeau</name>
      <address>
        <city>Anglet</city>
        <zip>64600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Besançon</name>
      <address>
        <city>Besançon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Clermont Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Dijon</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu de Lyon</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nantes University Hospital</name>
      <address>
        <city>Nantes</city>
        <zip>44100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aphp Hopital Saint Antoine</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Henri Laborit (Poitiers)</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier Guillaume Regnier Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH du Rouvray - Rouen</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Tours / CHRU de Tours</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>February 24, 2023</last_update_submitted>
  <last_update_submitted_qc>February 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>psychiatry</keyword>
  <keyword>health economics</keyword>
  <keyword>Neurostimulation</keyword>
  <keyword>tDCS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <!-- 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/NCT03758105
org study id: RC17_0493
nct id: NCT03758105
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the transcranial direct current stimulation (tDCS)
      cost-utility in the depression therapy.

      This is a 3 years medico-economics study with 1 year follow-up period involving patients with
      1 or 2 depression treatment(s) failed.

      Eligible subject will be randomized in 2 groups, usual care with tDCS cure (arm A) or only
      usual care (arm B).
Transcranial direct current stimulation is a non-invasive brain neuromodulation technique.
      tDCS can be a new therapy in depression.

      This study focuses on tDCS cost-utility-analysis. Each patient is following during 12 months.
      Patients are randomized in 2 arms. Arm A usual care with tDCS cure or arm B usual care
      without tDCS.

      Patient in arm A get a initial tDCS cure one week after randomization. If these patients are
      answering to the treatment, they can have a new cure in case of relapse. This new cure can
      start from the second month following initial treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cost-utility ratio, according to collective perspective of tDCS use in depression compared to usual care without active tDCS.
time frame: 12 months
description: The utility will be measured by :
Quality Adjusted Life Year (QALYs) as estimated from responses to the Euroqol-5 Dimensions (EQ-5D) health-related quality of life questionnaire. The questionnaire focuses on 5 dimensions: mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression. For each of these dimensions, 5 answers are possible.
The costs will be measured by the addition of the following costs:
Drugs dispensing via Health insurance database "National system of information of the French health insurance" (SNIIRAM), hospitalizations, work stoppages and care consumption collected in a declarative patient questionnaire.
measure: Budget impact analysis of spreading the most efficient strategy for using tDCS
time frame: 5 years
description: Comparison of intervention costs on the study sample and projection of these costs over 5 years, from the health insurance and hospital perspectives
measure: Response rate
time frame: at baseline, at the end of each tDCS cure (for Arm A patients) through study completion (12 months) and at 12 months for all patients
description: Response is defined as follows: decrease of the MADRS score by at least 50% compared to baseline score. MADRS stands for Montgomery-Asberg Depression Rating Scale. It is used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. A score from 0 to 6 being normal/symptom absent and a score >34 being severe depression.
measure: Remission rate
time frame: 12 months
description: Remission rate is defined as follows: MADRS score < 10 (see detailed description of MADRS in outcome 3)
measure: Relapse-free survival
time frame: 12 months
description: Number of patients with no relapse. Relapse is defined as follows: MADRS ≥ 20 (see detailed description of MADRS in outcome 3)
measure: MADRS score
time frame: At Baseline, one month, 2 months, 6 months and 12 months.
description: MADRS score (see detailed description of MADRS in outcome 3)
measure: Beck Depression Inventory (BDI) score
time frame: At Baseline, one month, 2 months, 6 months and 12 months.
description: The BDI is 13-item multiple-choice self-report inventory, for measuring the severity of depression. The global score is an addition of each item's score and ranges from 0 (minimal depression) to 39 (severe depression).
measure: Clinical Global Impression (CGI) score
time frame: At Baseline, one month, 2 months, 6 months and 12 months.
description: The Clinical Global Impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. Each scale is rated from 0 to 7. 0 being the best level and 7 the worst level.
measure: MOCA Score (Montreal Cognitive Assessment)
time frame: At Baseline, one month, 2 months, 6 months and 12 months.
description: Thirty items assessing multiple cognitive domains are contained in the MoCA: short-term memory (5 points); visuospatial abilities via clock drawing (3 points), and a cube copy task (1 point); executive functioning via an adaptation of Trail Making Test Part B (1 point), phonemic fluency (1 point), and verbal abstraction (2 points); attention, concentration, and working memory via target detection (1 point), serial subtraction (3 points), digits forward (1 point), and digits backward (1 point); language via confrontation naming with low-familiarity animals (3 points), and repetition of complex sentences (2 points); and orientation to time and place (6 points)
measure: Adverse events linked to the medical treatment for depression
time frame: 12 months
description: Number and types of adverse events linked to the medical treatment for depression
measure: Rate of suicide attempts
time frame: 12 months
description: number of suicide attempts per patient
measure: Rate of suicides
time frame: 12 months
description: number of suicides
measure: Treatment(s) switch(es)
time frame: At Baseline, one month, 2 months, 6 months and 12 months.
description: Number of treatment switches per patient
measure: Treatment(s) dose increase
time frame: At Baseline, one month, 2 months, 6 months and 12 months.
description: Number of drug(s) dose(s) increases prescribed to the patient
measure: Treatments combination(s)
time frame: at Baseline, one month, 2 months, 6 months and 12 months.
description: List of drugs (name) prescribed to the patient
measure: Declarative drug compliance via the MARS (Medication Adherence Report Scale)
time frame: at baseline and at 12 months
description: MARS is the Medication Adherence Report Scale, including 10 questions, the global score ranges from 0 to 10, 0 corresponds to the worst drug compliance and 10 to an excellent drug compliance
measure: Declarative drug compliance via the CRS (Clinician Rating Scale)
time frame: at baseline and at 12 months
description: CRS is the Clinician Rating Scale , including 7 questions, the global score ranges from 1 to 7, 7 being the worst level of drug compliance.
measure: Total number of tDCS sessions
time frame: 12 months
description: total number of tDCS sessions per patient
measure: Number of days between the successive tDCS cures
time frame: 12 months
description: Number of days between end of tDCS cure X and beginning of cure X+1, for each patient
measure: Adverse events linked to tDCS
time frame: 12 months
description: Number and types of adverse events linked to the tDCS
measure: Compliance with tDCS
time frame: 12 months
description: number of missed sessions over the number of planned sessions, per patient
measure: Patient acceptability of the tDCS technique: Analog Visual Scale
time frame: at the end of the first tDCS cure (up to one month)
description: Analog Visual Scale of acceptability of the tDCS completed by the patient, ranging from 0 to 10. 0 being "not acceptable" and 10 being "totally acceptable"
measure: professional status
time frame: At baseline
description: patient's professional status (active, unemployed, retired...)
measure: Impact of the implementation of the tDCS on the organization of care
time frame: 12 months
description: The organizational impact of the tDCS will be evaluated from the point of view of doctors, nurse and patients: staff, equipment, maintenance, location and mobilization time of these resources, using a specific questionnaire
arm group label: Usual care and tDCS (Arm A)
arm group type: Experimental
description: Arm A patient receives a first tDCS treatment in association with usual care (medication, psychotherapy...). If the patient is responding to tDCS, he can have other tDCS treatments in case of relapse.
arm group label: Usual care without tDCS (Arm B)
arm group type: Active Comparator
description: Arm B patient receives usual care: medication management and psychotherapy.
intervention type: Other
intervention name: tDCS associated with usual care
description: A tDCS cure will be given to the group "tDCS", one week after their randomization.
This will be done in association with usual care: medication and psychotherapy Parameters: Anodal stimulation on dorso-lateral prefrontal cortex left, 2mA current.
Treatment will consist of 15 days with 30 minutes stimulation per day, 5 days a week for 3 weeks.
arm group label: Usual care and tDCS (Arm A)
intervention type: Other
intervention name: Usual care
description: Medication and psychotherapy as prescribed in usual care
arm group label: Usual care without tDCS (Arm B)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: France
responsible party type: Sponsor
mesh term: Depression