<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/NCT02184221</url>
  </required_header>
  <id_info>
    <org_study_id>DMS-2010</org_study_id>
    <nct_id>NCT02184221</nct_id>
  </id_info>
  <brief_title>Deep-brain Magnetic Stimulation (DMS) in the Treatment of Major Depressive Disorder</brief_title>
  <acronym>DTMS</acronym>
  <official_title>The Effectiveness of Deep-brain Magnetic Stimulation in the Treatment of Major Depressive Disorder：a Preliminary Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Capital Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Capital Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Transcranial magnetic stimulation (TMS) is an effective alternative for pharmacotherapy in&#xD;
      major depressive disorder, but the effectiveness is not clear due to stimulated region,&#xD;
      frequency and intensity of magnet field. Standard TMS techniques only can stimulate&#xD;
      superficial cortical areas as the electric field decreases rapidly as a function of tissue&#xD;
      depth，while depression is also interconnected with deeper neuronal regions. Deep-brain&#xD;
      magnetic stimulation (DSM, or deep TMS, DTMS) allows stimulation of deeper cortical regions.&#xD;
      Previous research has demonstrated that alpha frequency (8-13 Hz) EEG activity may have&#xD;
      particular relevance to the response to antidepressants, and reduction of alpha frequency&#xD;
      (8-13 Hz) could lead to negative symptoms. It has been reported that both alpha frequency and&#xD;
      low-field magnetic stimulation could improve depressive symptoms.&#xD;
&#xD;
      The objective of this study is to compare the effectiveness of the two different parameters&#xD;
      of DMS in the treatment of major depressive disorder. The changes of brain derived&#xD;
      neurotropic factor (BDNF) are also investigated to make a relevant analysis of the&#xD;
      improvement of depressive symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is designed as randomized, double-blinded, active-controlled trial in major&#xD;
      depressive disorder.&#xD;
&#xD;
      Patients will be male or female, 18 to 60 years of age, right-handed, outpatient or inpatient&#xD;
      status, with diagnosis of major depressive episode (single or recurrent) by DSM-IV. The&#xD;
      HAMD-17 total score is no less than 18 at enrollment. The patients should be drug free at&#xD;
      least 30 days before entering the trial. The eligible patients are randomized to one of the&#xD;
      two treatment groups using a 1:1 ratio for the alpha frequency (high frequency) and 0.5Hz&#xD;
      (low frequency) groups.&#xD;
&#xD;
      Throughout the course of the study, DMS sessions are administered by trained physicians for&#xD;
      20 minutes at a time, with 5 sessions per week, during 6 consecutive weeks. Raters who are&#xD;
      blinded to the treatment arm perform evaluations. The effective outcome is assessed by the&#xD;
      HAMD-17 and HAMA every two weeks including randomization. Serum BDNF level are also tested at&#xD;
      each visits (Week 0, 2, 4 and 6). The safety in this study will be assessed by adverse event&#xD;
      reporting, clinical laboratory measurements and physical examinations.&#xD;
&#xD;
      Primary efficacy measure will be assessed based on the decrease of HAMD-17 from randomization&#xD;
      to endpoint (Week 6).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">April 2011</completion_date>
  <primary_completion_date type="Actual">January 2011</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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement of Depression</measure>
    <time_frame>From randomization to endpoint(Week 6)</time_frame>
    <description>the Change of 17-item Hamilton Depression Scale (HAMD-17) total score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of Anxiety</measure>
    <time_frame>From randomization to endpoint (Week 6)</time_frame>
    <description>the Change of Hamilton Anxiety Scale (HAMA) total score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission rate</measure>
    <time_frame>From randomization to endpoint (Week 6)</time_frame>
    <description>The proportion of subjects at endpoint with HAMD-17≤7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate</measure>
    <time_frame>From randomization to endpoint (Week 6)</time_frame>
    <description>The proportion of subjects at endpoint with the reduction of HAMD-17 total score&gt;=50%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety outcome 1</measure>
    <time_frame>From enrollment to endpoint (Week 6)</time_frame>
    <description>The incidence and nature of adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety outcome 2</measure>
    <time_frame>From randomization to endpoint (Week 6)</time_frame>
    <description>The number of subject withdrawal due to adverse events</description>
  </secondary_outcome>
  <other_outcome>
    <measure>BDNF change</measure>
    <time_frame>From randomization to endpoint (Week 6)</time_frame>
    <description>Change of serum BDNF level</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>High frequency stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>alpha burst, 8~12Hz, run 2 seconds, rest 8 seconds, lasts 20 minutes each time</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low frequency stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0.5Hz, run 0.5 seconds, rest 1.5 seconds, lasts 20 minutes each time</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High frequency stimulation</intervention_name>
    <description>The parameter of DMS: alpha frequency</description>
    <arm_group_label>High frequency stimulation</arm_group_label>
    <other_name>Alpha frequency stimulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Low frequency stimulation</intervention_name>
    <description>The parameter of DMS: 0.5Hz</description>
    <arm_group_label>Low frequency stimulation</arm_group_label>
    <other_name>0.5Hz stimulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has given written informed consent.&#xD;
&#xD;
          -  Aged from 18 to 60 years old.&#xD;
&#xD;
          -  Has a diagnosis of major depressive disorder by DSM-IV criteria.&#xD;
&#xD;
          -  HAMD-17 ≥ 18.&#xD;
&#xD;
          -  Right-handed.&#xD;
&#xD;
          -  Be drug free at least 30 days at randomization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current Axis I primary psychiatric diagnosis other than major depressive disorder.&#xD;
&#xD;
          -  Organic mental disease, including mental retardation.&#xD;
&#xD;
          -  History of clinically significant disease, including any cardiovascular, hepatic,&#xD;
             renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically&#xD;
             significant laboratory abnormality that is not stabilized or is anticipated to require&#xD;
             treatment during the study.&#xD;
&#xD;
          -  Subjects receiving an investigational agent (including different formulation and&#xD;
             generic agents of investigational drug) in the previous 3 months prior to screening.&#xD;
&#xD;
          -  Women in pregnancy or lactation, or female of child bearing potential without&#xD;
             appropriate birth control measures.&#xD;
&#xD;
          -  Has received ECT or MECT within 3 months prior to screening.&#xD;
&#xD;
          -  Significant risk of suicidal and/or self-harm behaviors.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gang Wang, M.D., Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Anding Hospital, Capital Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Anding Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100088</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>June 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Capital Medical University</investigator_affiliation>
    <investigator_full_name>Gang Wang, MD</investigator_full_name>
    <investigator_title>Head of Depression Center, Vice-principal of</investigator_title>
  </responsible_party>
  <keyword>Deep-brain magnetic stimulation</keyword>
  <keyword>Brain derived neurotropic factor</keyword>
  <keyword>Effectiveness</keyword>
  <keyword>Safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <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/NCT02184221
org study id: DMS-2010
nct id: NCT02184221
lead sponsor: 
has dmc: Yes
Transcranial magnetic stimulation (TMS) is an effective alternative for pharmacotherapy in
      major depressive disorder, but the effectiveness is not clear due to stimulated region,
      frequency and intensity of magnet field. Standard TMS techniques only can stimulate
      superficial cortical areas as the electric field decreases rapidly as a function of tissue
      depth，while depression is also interconnected with deeper neuronal regions. Deep-brain
      magnetic stimulation (DSM, or deep TMS, DTMS) allows stimulation of deeper cortical regions.
      Previous research has demonstrated that alpha frequency (8-13 Hz) EEG activity may have
      particular relevance to the response to antidepressants, and reduction of alpha frequency
      (8-13 Hz) could lead to negative symptoms. It has been reported that both alpha frequency and
      low-field magnetic stimulation could improve depressive symptoms.

      The objective of this study is to compare the effectiveness of the two different parameters
      of DMS in the treatment of major depressive disorder. The changes of brain derived
      neurotropic factor (BDNF) are also investigated to make a relevant analysis of the
      improvement of depressive symptoms.
The study is designed as randomized, double-blinded, active-controlled trial in major
      depressive disorder.

      Patients will be male or female, 18 to 60 years of age, right-handed, outpatient or inpatient
      status, with diagnosis of major depressive episode (single or recurrent) by DSM-IV. The
      HAMD-17 total score is no less than 18 at enrollment. The patients should be drug free at
      least 30 days before entering the trial. The eligible patients are randomized to one of the
      two treatment groups using a 1:1 ratio for the alpha frequency (high frequency) and 0.5Hz
      (low frequency) groups.

      Throughout the course of the study, DMS sessions are administered by trained physicians for
      20 minutes at a time, with 5 sessions per week, during 6 consecutive weeks. Raters who are
      blinded to the treatment arm perform evaluations. The effective outcome is assessed by the
      HAMD-17 and HAMA every two weeks including randomization. Serum BDNF level are also tested at
      each visits (Week 0, 2, 4 and 6). The safety in this study will be assessed by adverse event
      reporting, clinical laboratory measurements and physical examinations.

      Primary efficacy measure will be assessed based on the decrease of HAMD-17 from randomization
      to endpoint (Week 6).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Improvement of Depression
time frame: From randomization to endpoint(Week 6)
description: the Change of 17-item Hamilton Depression Scale (HAMD-17) total score
measure: Improvement of Anxiety
time frame: From randomization to endpoint (Week 6)
description: the Change of Hamilton Anxiety Scale (HAMA) total score
measure: Remission rate
time frame: From randomization to endpoint (Week 6)
description: The proportion of subjects at endpoint with HAMD-17≤7
measure: Response rate
time frame: From randomization to endpoint (Week 6)
description: The proportion of subjects at endpoint with the reduction of HAMD-17 total score>=50%
measure: Safety outcome 1
time frame: From enrollment to endpoint (Week 6)
description: The incidence and nature of adverse events
measure: Safety outcome 2
time frame: From randomization to endpoint (Week 6)
description: The number of subject withdrawal due to adverse events
measure: BDNF change
time frame: From randomization to endpoint (Week 6)
description: Change of serum BDNF level
arm group label: High frequency stimulation
arm group type: Experimental
description: alpha burst, 8~12Hz, run 2 seconds, rest 8 seconds, lasts 20 minutes each time
arm group label: Low frequency stimulation
arm group type: Active Comparator
description: 0.5Hz, run 0.5 seconds, rest 1.5 seconds, lasts 20 minutes each time
intervention type: Device
intervention name: High frequency stimulation
description: The parameter of DMS: alpha frequency
arm group label: High frequency stimulation
other name: Alpha frequency stimulation
intervention type: Device
intervention name: Low frequency stimulation
description: The parameter of DMS: 0.5Hz
arm group label: Low frequency stimulation
other name: 0.5Hz stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Gang Wang, M.D., Ph.D
role: Principal Investigator
affiliation: Beijing Anding Hospital, Capital Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Capital Medical University
investigator full name: Gang Wang, MD
investigator title: Head of Depression Center, Vice-principal of
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major