<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/NCT03304600</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A01983-48</org_study_id>
    <nct_id>NCT03304600</nct_id>
  </id_info>
  <brief_title>tDCS for Treatment Resistant Obsessive Compulsive Disorder</brief_title>
  <acronym>tDCS-TOC</acronym>
  <official_title>Transcranial Direct Current Stimulation (tDCS) to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Henri Laborit</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      It's a multicentric, randomized, controlled study concerning 100 patients with&#xD;
      treatment-resistant obsessive compulsive disorders (OCD). The aim of this study is to&#xD;
      evaluate the effect of transcranial direct current stimulation (tDCS) on OCD patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 3, 2017</start_date>
  <completion_date type="Actual">February 24, 2022</completion_date>
  <primary_completion_date type="Actual">February 24, 2022</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Yale Brown Obsessive Compulsive Scale (YBOCS) score</measure>
    <time_frame>2 weeks</time_frame>
    <description>The primary objective of the study is to compare the change in Yale Brown Obsessive Compulsive Scale (YBOCS) scores from baseline to the week 2 (post-tDCS treatment) visit, between the two treatments groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Yale Brown Obsessive Compulsive Scale (YBOCS)</measure>
    <time_frame>Month 1</time_frame>
    <description>i. Change from baseline to month 1 in Yale Brown Obsessive Compulsive Scale (YBOCS) scores, between treatment groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Yale Brown Obsessive Compulsive Scale (YBOCS),</measure>
    <time_frame>Month 3</time_frame>
    <description>ii. Response rate at month 3 in Yale Brown Obsessive Compulsive Scale (YBOCS) score from baseline, between treatment groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression (CGI)</measure>
    <time_frame>Month 1</time_frame>
    <description>Change from baseline to month 1 in above scales between treatment groups;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression (CGI)</measure>
    <time_frame>Month 3</time_frame>
    <description>Change from baseline to month 3 in above scales between treatment groups;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brown Assessment of Beliefs Scale (BABS)</measure>
    <time_frame>Month 1</time_frame>
    <description>Change from baseline to month 1 in above scales between treatment groups;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brown Assessment of Beliefs Scale (BABS)</measure>
    <time_frame>Month 3</time_frame>
    <description>Change from baseline to month 3 in above scales between treatment groups;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Anxiety Scale (BAS)</measure>
    <time_frame>Month 1</time_frame>
    <description>Change from baseline to month 1 in above scales between treatment groups;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Anxiety Scale (BAS)</measure>
    <time_frame>Month 3</time_frame>
    <description>Change from baseline to month 3 in above scales between treatment groups;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montgomery and Asberg Depression Rating Scale (MADRS)</measure>
    <time_frame>Month 1</time_frame>
    <description>Change from baseline to month 1 in above scales between treatment groups;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montgomery and Asberg Depression Rating Scale (MADRS)</measure>
    <time_frame>Month 3</time_frame>
    <description>Change from baseline to month 3 in above scales between treatment groups;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression scale (HAD)</measure>
    <time_frame>Month 1</time_frame>
    <description>Change from baseline to month 1 in above scales between treatment groups;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression scale (HAD)</measure>
    <time_frame>Month 3</time_frame>
    <description>Change from baseline to month 3 in above scales between treatment groups;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sheehan Disability Scale, (SDS)</measure>
    <time_frame>Month 1</time_frame>
    <description>Change from baseline to month 1 in above scales between treatment groups;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sheehan Disability Scale, (SDS)</measure>
    <time_frame>Month 3</time_frame>
    <description>Change from baseline to month 3 in above scales between treatment groups;</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>3 Month</time_frame>
    <description>Safety of the tDCS treatment :&#xD;
assessed by physical examination during each tDCS session&#xD;
any other adverse events (AEs)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">83</enrollment>
  <condition>Obsessive-Compulsive Disorder</condition>
  <arm_group>
    <arm_group_label>Active stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 sessions (1 per day during 2 week) of active tDCS stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>10 sessions (1 per day during 2 week) of sham stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active stimulation</intervention_name>
    <description>Patients will receive a tDCS stimulation during 30 mn with an intensity of 2 milliampere (mA).</description>
    <arm_group_label>Active stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham stimulation</intervention_name>
    <description>Patients will receive a Sham stimulation during 30 mn</description>
    <arm_group_label>Sham Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meets criteria for obsessive compulsive disorder according to Diagnostic and&#xD;
             Statistical Manual (DSM IV) with a &quot;good insight&quot; (BABS)&#xD;
&#xD;
          -  No current depressive and suicidal risks&#xD;
&#xD;
          -  No epileptic pathology&#xD;
&#xD;
          -  Age: Participants will be both males and females, 18-70 years of age included.&#xD;
&#xD;
          -  Chronic Obsessive compulsive disorder ( Total Y-BOCS&gt;20 or Y-BOCS one subscale &gt; 15)&#xD;
&#xD;
          -  Obsessive compulsive disorder resistant to pharmacology treatment :&#xD;
&#xD;
               1. at least 2 antidepressants (IRS type) (&gt; 12 weeks)&#xD;
&#xD;
               2. cognitive and comportment therapy since at least one year&#xD;
&#xD;
          -  Treatment stability (antidepressants) for more than 12 weeks without significant&#xD;
             improvement.&#xD;
&#xD;
          -  Affiliation to a social security system (recipient or assignee),&#xD;
&#xD;
          -  Signed written inform consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female subject who is pregnant, or of child-bearing age, sexually active and not using&#xD;
             reliable contraception or who is nursing,&#xD;
&#xD;
          -  Patient under curators&#xD;
&#xD;
          -  Patient hospitalized under duress&#xD;
&#xD;
          -  Meets another diagnosis of axe 1 of DSM-IV&#xD;
&#xD;
          -  Current depressive or suicidal risks&#xD;
&#xD;
          -  Patient with any form of metal in the cranium, a pacemaker, skull defects, or skin&#xD;
             lesions to the scalp (cuts, abrasions, rash)&#xD;
&#xD;
          -  Epileptic patient&#xD;
&#xD;
          -  Patient with a medical history of cranial trauma&#xD;
&#xD;
          -  Patient unable to give his or hers informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Damien HEIT, MD</last_name>
    <role>Study Director</role>
    <affiliation>Centre Hospitalier Henri Laborit</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospices Civils De Lyon</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Henri Laborit</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.H. Guillaume Regnier</name>
      <address>
        <city>Rennes</city>
        <zip>35703</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>April 21, 2022</last_update_submitted>
  <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>OCD</keyword>
  <keyword>tDCS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Compulsive Personality Disorder</mesh_term>
    <mesh_term>Obsessive-Compulsive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03304600
org study id: 2016-A01983-48
nct id: NCT03304600
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It's a multicentric, randomized, controlled study concerning 100 patients with
      treatment-resistant obsessive compulsive disorders (OCD). The aim of this study is to
      evaluate the effect of transcranial direct current stimulation (tDCS) on OCD patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Yale Brown Obsessive Compulsive Scale (YBOCS) score
time frame: 2 weeks
description: The primary objective of the study is to compare the change in Yale Brown Obsessive Compulsive Scale (YBOCS) scores from baseline to the week 2 (post-tDCS treatment) visit, between the two treatments groups
measure: Yale Brown Obsessive Compulsive Scale (YBOCS)
time frame: Month 1
description: i. Change from baseline to month 1 in Yale Brown Obsessive Compulsive Scale (YBOCS) scores, between treatment groups.
measure: Yale Brown Obsessive Compulsive Scale (YBOCS),
time frame: Month 3
description: ii. Response rate at month 3 in Yale Brown Obsessive Compulsive Scale (YBOCS) score from baseline, between treatment groups.
measure: Clinical Global Impression (CGI)
time frame: Month 1
description: Change from baseline to month 1 in above scales between treatment groups;
measure: Clinical Global Impression (CGI)
time frame: Month 3
description: Change from baseline to month 3 in above scales between treatment groups;
measure: Brown Assessment of Beliefs Scale (BABS)
time frame: Month 1
description: Change from baseline to month 1 in above scales between treatment groups;
measure: Brown Assessment of Beliefs Scale (BABS)
time frame: Month 3
description: Change from baseline to month 3 in above scales between treatment groups;
measure: Brief Anxiety Scale (BAS)
time frame: Month 1
description: Change from baseline to month 1 in above scales between treatment groups;
measure: Brief Anxiety Scale (BAS)
time frame: Month 3
description: Change from baseline to month 3 in above scales between treatment groups;
measure: Montgomery and Asberg Depression Rating Scale (MADRS)
time frame: Month 1
description: Change from baseline to month 1 in above scales between treatment groups;
measure: Montgomery and Asberg Depression Rating Scale (MADRS)
time frame: Month 3
description: Change from baseline to month 3 in above scales between treatment groups;
measure: Hospital Anxiety and Depression scale (HAD)
time frame: Month 1
description: Change from baseline to month 1 in above scales between treatment groups;
measure: Hospital Anxiety and Depression scale (HAD)
time frame: Month 3
description: Change from baseline to month 3 in above scales between treatment groups;
measure: Sheehan Disability Scale, (SDS)
time frame: Month 1
description: Change from baseline to month 1 in above scales between treatment groups;
measure: Sheehan Disability Scale, (SDS)
time frame: Month 3
description: Change from baseline to month 3 in above scales between treatment groups;
measure: Number of adverse events
time frame: 3 Month
description: Safety of the tDCS treatment :
assessed by physical examination during each tDCS session
any other adverse events (AEs)
arm group label: Active stimulation
arm group type: Experimental
description: 10 sessions (1 per day during 2 week) of active tDCS stimulation
arm group label: Sham Stimulation
arm group type: Sham Comparator
description: 10 sessions (1 per day during 2 week) of sham stimulation
intervention type: Device
intervention name: Active stimulation
description: Patients will receive a tDCS stimulation during 30 mn with an intensity of 2 milliampere (mA).
arm group label: Active stimulation
intervention type: Device
intervention name: Sham stimulation
description: Patients will receive a Sham stimulation during 30 mn
arm group label: Sham Stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Damien HEIT, MD
role: Study Director
affiliation: Centre Hospitalier Henri Laborit
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder
sharing ipd: Undecided