<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/NCT02213016</url>
  </required_header>
  <id_info>
    <org_study_id>141-2011</org_study_id>
    <nct_id>NCT02213016</nct_id>
  </id_info>
  <brief_title>Effectiveness of Repetitive Transcranial Magnetic Stimulation in Depressed Patients</brief_title>
  <official_title>Evaluation of the Efficacy of Repetitive Transcranial Magnetic Stimulation on Cognitive, Anxiety and Depressive Symptoms in Patients Diagnosed With Major Depressive Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Nacional Autonoma de Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Nacional Autonoma de Mexico</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate clinical efficacy (affective and cognitive) in&#xD;
      patients with moderate depression between TMS over the left Dorsolateral Prefrontal Cortex&#xD;
      (DLPFC) with simulated TMS, as well as clinical response when 5 sessions / week are applied&#xD;
      vs. 2 sessions / week. All patients will receive 15 TMS sessions as initial treatment (active&#xD;
      or sham) and respondents will participate in an TMS follow-up on the left DLPFC for three&#xD;
      months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blinded, placebo-controlled, parallel group clinical trial to&#xD;
      evaluate the efficacy of two Transcranial Magnetic Stimulation (TMS) protocols in patients&#xD;
      with major depressive disorder (MDD). 70 ambulatory patients with a MDD diagnosis from the&#xD;
      Clinic at the Department of Psychiatry and Mental Health at the Universidad Nacional Autónoma&#xD;
      de México (UNAM) will be included. All Patients will complete a total of 15 sessions of&#xD;
      treatment in any of four groups: A group of patients will be randomly assigned to receive&#xD;
      either 5 active TMS sessions or 2 sessions per week. Sham controls will also be randomly&#xD;
      assigned to receive either 5 TMS sessions or 2 sessions per week. Afterwards, all&#xD;
      participants will receive 2 sessions per month for a 3 month period. Depressive and anxiety&#xD;
      symptoms will be evaluated at baseline, and every 5 TMS sessions during the acute treatment&#xD;
      phase, and once at the end of a 3-month follow up. In addition, neuropsychological&#xD;
      evaluations will be applied at baseline and at the end of the 15 session's treatment.&#xD;
      Sessions will be applied with a MAG pro x 100 transcranial magnetic stimulator. Motor&#xD;
      threshold will be set. Sessions will be applied over the left DLPFC at 5 Hz, 30 trains, 100%.&#xD;
      Categorical variables will be described by percentages and frequencies. Continuous variables&#xD;
      will be described by means and standard deviations. Treatment groups will be compared using&#xD;
      Student's T test. Cognitive, anxiety and depressive symptom scale scores between treatment&#xD;
      groups will be compared using repeated measures ANOVA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2013</start_date>
  <completion_date type="Anticipated">February 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2016</primary_completion_date>
  <phase>Phase 4</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>Total scores on the Hamilton depression scale depression</measure>
    <time_frame>After 15 sessions of treatment and at 3 months follow up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Performance on the Wisconsin card sorting test</measure>
    <time_frame>After 15 sessions of treatment and at 3 months follow-up</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Performance on stop signal task</measure>
    <time_frame>After 15 sessions of treatment and at 3 months follow-up</time_frame>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Major Depression</condition>
  <arm_group>
    <arm_group_label>Transcranial magnetic stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham repetitive Transcranial magnetic stimulation, 5 Hz, 5 sessions per week for three weeks: Total of 15 sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transcraneal magnetic stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active repetitive Transcranial magnetic stimulation, 5 Hz, 5 sessions per week for three weeks: Total of 15 sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Comparator</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham repetitive Transcranial magnetic stimulation, 5 Hz, 2 sessions per week for 7 1/2 weeks: Total of 15 sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active repetitive Transcranial magnetic stimulation, 5 Hz, 2 sessions per week for 7 1/2 weeks: Total of 15 sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial Magnetic Stimulation</intervention_name>
    <arm_group_label>Active Comparator</arm_group_label>
    <arm_group_label>Transcraneal magnetic stimulation</arm_group_label>
    <other_name>TMS device MagVenture model MagPro 100</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Transcranial Magnetic Stimulation</intervention_name>
    <arm_group_label>Sham Comparator</arm_group_label>
    <arm_group_label>Transcranial magnetic stimulation</arm_group_label>
    <other_name>TMS device Magventure, model MagPro 100. COIL COOL-B65.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of major depressive disorder&#xD;
&#xD;
          -  Having a greater or equal score to 18 points in the Ham-D scale at the moment of the&#xD;
             initial evaluation&#xD;
&#xD;
          -  Treatment free patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Epilepsy or seizure risk record&#xD;
&#xD;
          -  Carry metallic objects in the head (such as arterial clips, plates, screws), eye or&#xD;
             brain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Gabriela Armas-Castañeda, MD</last_name>
    <phone>+525556228222</phone>
    <phone_ext>43139</phone_ext>
    <email>drgaba1@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Psychiatry and Mental Health, Faculty of Medicine, UNAM</name>
      <address>
        <city>Mexico</city>
        <state>Mexico City</state>
        <zip>04510</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gabriela Armas, MD</last_name>
      <phone>+5255 56228222</phone>
      <phone_ext>43139</phone_ext>
      <email>drgaba1@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Francisco Romo, MD</last_name>
      <phone>+5255 56228222</phone>
      <phone_ext>43137</phone_ext>
      <email>franciscoromo@yahoo.com</email>
    </contact_backup>
    <investigator>
      <last_name>Gabriela Armas, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>Unable to connect to PubMed to validate , last attempt on May 29, 2014 at 3:25 PM EDT</citation>
  </reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>August 8, 2014</last_update_submitted>
  <last_update_submitted_qc>August 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Nacional Autonoma de Mexico</investigator_affiliation>
    <investigator_full_name>Gabriela Armas Castañeda</investigator_full_name>
    <investigator_title>Technical academic</investigator_title>
  </responsible_party>
  <keyword>Stimulation magnetic transcranial, major depression, cognitive impairment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</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/NCT02213016
org study id: 141-2011
nct id: NCT02213016
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate clinical efficacy (affective and cognitive) in
      patients with moderate depression between TMS over the left Dorsolateral Prefrontal Cortex
      (DLPFC) with simulated TMS, as well as clinical response when 5 sessions / week are applied
      vs. 2 sessions / week. All patients will receive 15 TMS sessions as initial treatment (active
      or sham) and respondents will participate in an TMS follow-up on the left DLPFC for three
      months.
This is a randomized, double-blinded, placebo-controlled, parallel group clinical trial to
      evaluate the efficacy of two Transcranial Magnetic Stimulation (TMS) protocols in patients
      with major depressive disorder (MDD). 70 ambulatory patients with a MDD diagnosis from the
      Clinic at the Department of Psychiatry and Mental Health at the Universidad Nacional Autónoma
      de México (UNAM) will be included. All Patients will complete a total of 15 sessions of
      treatment in any of four groups: A group of patients will be randomly assigned to receive
      either 5 active TMS sessions or 2 sessions per week. Sham controls will also be randomly
      assigned to receive either 5 TMS sessions or 2 sessions per week. Afterwards, all
      participants will receive 2 sessions per month for a 3 month period. Depressive and anxiety
      symptoms will be evaluated at baseline, and every 5 TMS sessions during the acute treatment
      phase, and once at the end of a 3-month follow up. In addition, neuropsychological
      evaluations will be applied at baseline and at the end of the 15 session's treatment.
      Sessions will be applied with a MAG pro x 100 transcranial magnetic stimulator. Motor
      threshold will be set. Sessions will be applied over the left DLPFC at 5 Hz, 30 trains, 100%.
      Categorical variables will be described by percentages and frequencies. Continuous variables
      will be described by means and standard deviations. Treatment groups will be compared using
      Student's T test. Cognitive, anxiety and depressive symptom scale scores between treatment
      groups will be compared using repeated measures ANOVA.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Total scores on the Hamilton depression scale depression
time frame: After 15 sessions of treatment and at 3 months follow up
measure: Performance on the Wisconsin card sorting test
time frame: After 15 sessions of treatment and at 3 months follow-up
measure: Performance on stop signal task
time frame: After 15 sessions of treatment and at 3 months follow-up
arm group label: Transcranial magnetic stimulation
arm group type: Sham Comparator
description: Sham repetitive Transcranial magnetic stimulation, 5 Hz, 5 sessions per week for three weeks: Total of 15 sessions.
arm group label: Transcraneal magnetic stimulation
arm group type: Active Comparator
description: Active repetitive Transcranial magnetic stimulation, 5 Hz, 5 sessions per week for three weeks: Total of 15 sessions.
arm group label: Sham Comparator
arm group type: Sham Comparator
description: Sham repetitive Transcranial magnetic stimulation, 5 Hz, 2 sessions per week for 7 1/2 weeks: Total of 15 sessions.
arm group label: Active Comparator
arm group type: Active Comparator
description: Active repetitive Transcranial magnetic stimulation, 5 Hz, 2 sessions per week for 7 1/2 weeks: Total of 15 sessions.
intervention type: Device
intervention name: Transcranial Magnetic Stimulation
arm group label: Active Comparator
arm group label: Transcraneal magnetic stimulation
other name: TMS device MagVenture model MagPro 100
intervention type: Device
intervention name: Sham Transcranial Magnetic Stimulation
arm group label: Sham Comparator
arm group label: Transcranial magnetic stimulation
other name: TMS device Magventure, model MagPro 100. COIL COOL-B65.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Gabriela Armas-Castañeda, MD
phone: +525556228222
phone ext: 43139
email: drgaba1@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Mexico
citation: Unable to connect to PubMed to validate , last attempt on May 29, 2014 at 3:25 PM EDT
responsible party type: Principal Investigator
investigator affiliation: Universidad Nacional Autonoma de Mexico
investigator full name: Gabriela Armas Castañeda
investigator title: Technical academic
mesh term: Depression
mesh term: Depressive Disorder, Major