<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/NCT03012724</url>
  </required_header>
  <id_info>
    <org_study_id>CTP-0001-01</org_study_id>
    <nct_id>NCT03012724</nct_id>
  </id_info>
  <brief_title>Efficacy of H7-Coil DTMS Compared to H1-Coil DTMS in Subjects With Major Depression Disorder (MDD)</brief_title>
  <official_title>A Prospective Multicenter Double Blind Randomized Controlled Trial to Demonstrate That the Efficacy of the H7-Coil is as Good as the Efficacy of the H1-Coil Deep Transcranial Magnetic Stimulation (DTMS) in Subjects With Major Depression Disorder (MDD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brainsway</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brainsway</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to demonstrate that the efficacy and safety of deep brain rTMS,&#xD;
      (Transcranial Magnetic Stimulation) H7-Coil treatment as add on treatment, is as good as the&#xD;
      FDA cleared, H1-Coil, in subjects with major depressive disorder that have been previously&#xD;
      unsuccessfully treated with antidepressant medications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, 6 week, double blind, randomized, controlled, multi-center trial. The&#xD;
      study will explore the safety and efficacy of deep brain rTMS (Transcranial Magnetic&#xD;
      Stimulation) H7-Coil treatment and demonstrate that it is as good as the FDA cleared, H1-Coil&#xD;
      treatment as add-on for a treatment with antidepressant drugs (a bi-therapeutic treatment )&#xD;
      in subjects with major depressive disorder that have been previously unsuccessfully treated&#xD;
      with antidepressant medication.&#xD;
&#xD;
      Approximately 146 subjects will be enrolled in the study. The study population consists of&#xD;
      subjects with MDD who have failed adequate medication treatment and who are in a current&#xD;
      depressive episode.&#xD;
&#xD;
      The patients will be of all racial, ethnic and gender categories, ranging from 22 to 68 years&#xD;
      of age, and have HDRS-21≥20. Outpatients will be recruited from both academic and private&#xD;
      research centers.&#xD;
&#xD;
      The study duration is 8 weeks, with a 2 week period of screening and baseline, followed by 4&#xD;
      weeks of 5 daily treatments and 2 weeks of biweekly treatments. Mood and mental state will be&#xD;
      carefully monitored through standard psychological scales and assessments during the&#xD;
      screening and baseline and throughout treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 30, 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HDRS-21 Score Change From Baseline</measure>
    <time_frame>Week 6 post randomization</time_frame>
    <description>Change from baseline in HDRS-21 scores at week 6 post-randomization in the H7 group compared to the H1 group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response Rate in HDRS-21</measure>
    <time_frame>Week 6 post randomization</time_frame>
    <description>Percentage of patients with reduction in HDRS-21 score from baseline in the H7 group compared to the H1 group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission Rate</measure>
    <time_frame>Week 6 post randomization</time_frame>
    <description>Percentage of patients in remission, at week 6 post-randomization assessment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">106</enrollment>
  <condition>Major Depressive Disorder (MDD)</condition>
  <arm_group>
    <arm_group_label>H1-Coil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Device: Brainsway H1-Coil Deep TMS System. An FDA cleared deep transcranial magnetic stimulation device. The coil is designed to allow deeper brain stimulation in the lateral prefrontal cortex, including the anterior cingulated cortex without a significant increase of electric fields induced in superficial cortical regions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>H7-Coil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device: Brainsway H7-Coil Deep TMS System. A deep transcranial magnetic stimulation device. The coil is designed to allow deeper brain stimulation in the medial prefrontal cortex, including the anterior cingulated cortex without a significant increase of electric fields induced in superficial cortical regions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>H7-Coil</intervention_name>
    <description>Deep transcranial magnetic stimulation for the treatment of major dispersion disorder with the H7-Coil</description>
    <arm_group_label>H7-Coil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>H1-Coil</intervention_name>
    <description>Deep transcranial magnetic stimulation for the treatment of major depression disorder with the FDA cleared H1-Coil</description>
    <arm_group_label>H1-Coil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Outpatients&#xD;
&#xD;
          -  Men and women 22-68 years of age&#xD;
&#xD;
          -  Primary DSM-IV diagnosis of Major Depression, single or recurrent episode.&#xD;
&#xD;
          -  Current depressive episode is less than 5 years duration&#xD;
&#xD;
          -  The patient did not respond to at least one but not more than four antidepressant&#xD;
             treatments in the current episode or Patients who have not completed antidepressant&#xD;
             trials due to intolerance to therapy of 2 or more anti-depressant medications in the&#xD;
             current episode&#xD;
&#xD;
          -  Satisfactory safety screening questionnaire for transcranial magnetic stimulation&#xD;
&#xD;
          -  Patients not suffering from hypo or hyper-thyroidism based on pre-study TSH level or&#xD;
             medically stabilized&#xD;
&#xD;
          -  Capable and willing to provide informed consent and able to adhere to the treatment&#xD;
             schedule&#xD;
&#xD;
          -  Patient is stable on medication for 2 month and is not expected to change medication&#xD;
             during all study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals diagnosed by the Investigator with the following conditions (current&#xD;
             unless otherwise stated):&#xD;
&#xD;
               -  Depression secondary to a general medical condition, or substance-induced&#xD;
&#xD;
               -  History of substance abuse or dependence within the past 6 month (except nicotine&#xD;
                  and caffeine)&#xD;
&#xD;
               -  Any psychotic disorder (lifetime), including schizoaffective disorder, or major&#xD;
                  depression with psychotic features, Bipolar disorder, Eating disorder, Obsessive&#xD;
                  compulsive disorder&#xD;
&#xD;
               -  Post-traumatic stress disorder (current or within the past year)&#xD;
&#xD;
               -  Current generalized anxiety disorder, panic disorder or social anxiety disorder&#xD;
&#xD;
               -  Presence of a personality disorder (such as antisocial, schizotypal, histrionic,&#xD;
                  borderline, narcissistic)&#xD;
&#xD;
          -  Individuals with a significant neurological disorder or insult including, but not&#xD;
             limited to:&#xD;
&#xD;
               -  Any condition likely to be associated with increased intracranial pressure&#xD;
&#xD;
               -  Space occupying brain lesion&#xD;
&#xD;
               -  Any history of seizure EXCEPT those therapeutically induced by ECT&#xD;
&#xD;
               -  History of cerebrovascular accident&#xD;
&#xD;
               -  Transient ischemic attack within two years&#xD;
&#xD;
               -  Cerebral aneurysm&#xD;
&#xD;
               -  Dementia&#xD;
&#xD;
               -  Mini Mental State Exam score of less than or equal to 24&#xD;
&#xD;
               -  Parkinson's disease&#xD;
&#xD;
               -  Huntington's chorea&#xD;
&#xD;
               -  Multiple sclerosis&#xD;
&#xD;
               -  Increased risk of seizure for any reason&#xD;
&#xD;
               -  Individuals with hearing loss&#xD;
&#xD;
          -  ECT treatment within 3 months prior to the screening visit&#xD;
&#xD;
          -  History of treatment with Vagus Nerve Stimulation (VNS)&#xD;
&#xD;
          -  History of treatment with Deep Brain Stimulation (DBS)&#xD;
&#xD;
          -  Use of any investigational drug within 4 weeks of the randomization visit&#xD;
&#xD;
          -  Use of any prohibited study medication(s)&#xD;
&#xD;
          -  Present suicidal risk as assessed by the investigator or significant suicide risk&#xD;
&#xD;
          -  Any self-inflicted harm in the past 3 months not in the context of suicidal ideation&#xD;
&#xD;
          -  Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable&#xD;
             cardiac disease&#xD;
&#xD;
          -  Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or&#xD;
             electrodes) or any other metal object within or near the head, excluding the mouth,&#xD;
             that cannot be safely removed&#xD;
&#xD;
          -  Implanted neurostimulators&#xD;
&#xD;
          -  History of abnormal MRI&#xD;
&#xD;
          -  Known or suspected pregnancy&#xD;
&#xD;
          -  If participating in psychotherapy, must have been in stable treatment for at least 3&#xD;
             months prior to entry into the study, with no anticipation of change in the frequency&#xD;
             of therapeutic sessions, or the therapeutic focus over the duration of the rTMS trial&#xD;
&#xD;
          -  Clinically significant laboratory abnormality, in the opinion of the Investigator&#xD;
             based on CBC and biochemistry&#xD;
&#xD;
          -  Women of childbearing potential and not using a medically accepted form of&#xD;
             contraception when engaging in sexual intercourse&#xD;
&#xD;
          -  Women: if pregnant, planning on becoming pregnant, or currently nursing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>68 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Amit Ezra</last_name>
    <phone>+972-503103134</phone>
    <email>amite@brainsway.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kadima Neuropsychiatry</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cheryl Jacobson</last_name>
      <phone>858-412-4130</phone>
      <email>clinicaltrials@kadimanp.com</email>
    </contact>
    <investigator>
      <last_name>David Feifel, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CalNeuro Research Group</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90024</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christina Fosteson</last_name>
      <phone>310-208-7144</phone>
      <email>cfosteson@calneuroresearch.com</email>
    </contact>
    <investigator>
      <last_name>Alexander Bystritsky</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Advanced Mental Health Care Inc. - Juno Beach</name>
      <address>
        <city>Juno Beach</city>
        <state>Florida</state>
        <zip>33408</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elyssa Sisko</last_name>
      <phone>561-267-8876</phone>
      <email>elyssasisko@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Aron Tendler, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Advanced Mental Health Care Inc. - Palm Beach</name>
      <address>
        <city>Palm Beach</city>
        <state>Florida</state>
        <zip>33480</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elyssa Sisko</last_name>
      <phone>561-333-8884</phone>
    </contact>
    <contact_backup>
      <phone>561-386-1600</phone>
    </contact_backup>
    <investigator>
      <last_name>Aron Tendler</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Advanced Mental Health Care Inc. - Royal Palm Beach</name>
      <address>
        <city>Royal Palm Beach</city>
        <state>Florida</state>
        <zip>33411</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elyssa Sisko</last_name>
      <phone>561-267-8876</phone>
      <email>elyssasisko@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Aron Tendler, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Morgan Dancy, BsC</last_name>
      <email>maddoxm@musc.edu</email>
    </contact>
    <investigator>
      <last_name>Mark George, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Greenbrook TMS NeuroHealth Centers</name>
      <address>
        <city>McLean</city>
        <state>Virginia</state>
        <zip>22102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jessica Oleksik</last_name>
      <phone>703-356-1568</phone>
      <email>joleksik@greenbrooktms.com</email>
    </contact>
    <contact_backup>
      <last_name>Kirsten Burke</last_name>
      <phone>703-356-1568</phone>
    </contact_backup>
    <investigator>
      <last_name>Geoffrey Grammer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Center for Addiction &amp; Mental Health (CAMH)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6J 1H4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shobha Mehta</last_name>
      <phone>416-5358501</phone>
      <phone_ext>33662</phone_ext>
      <email>Shobha.Mehta@camh.ca</email>
    </contact>
    <investigator>
      <last_name>Daniel Blumberger, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dr. Hadar Shalev</name>
      <address>
        <city>Be'er Sheva'</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tali Gulevsky</last_name>
      <phone>+972-8-6479180</phone>
      <email>gulevsky@post.bgu.ac.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Israel</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TMS</keyword>
  <keyword>Deep Transcranial Magnetic Stimulation</keyword>
  <keyword>MDD</keyword>
  <keyword>Major Depressive Disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</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/NCT03012724
org study id: CTP-0001-01
nct id: NCT03012724
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The purpose of the study is to demonstrate that the efficacy and safety of deep brain rTMS,
      (Transcranial Magnetic Stimulation) H7-Coil treatment as add on treatment, is as good as the
      FDA cleared, H1-Coil, in subjects with major depressive disorder that have been previously
      unsuccessfully treated with antidepressant medications.
This is a prospective, 6 week, double blind, randomized, controlled, multi-center trial. The
      study will explore the safety and efficacy of deep brain rTMS (Transcranial Magnetic
      Stimulation) H7-Coil treatment and demonstrate that it is as good as the FDA cleared, H1-Coil
      treatment as add-on for a treatment with antidepressant drugs (a bi-therapeutic treatment )
      in subjects with major depressive disorder that have been previously unsuccessfully treated
      with antidepressant medication.

      Approximately 146 subjects will be enrolled in the study. The study population consists of
      subjects with MDD who have failed adequate medication treatment and who are in a current
      depressive episode.

      The patients will be of all racial, ethnic and gender categories, ranging from 22 to 68 years
      of age, and have HDRS-21≥20. Outpatients will be recruited from both academic and private
      research centers.

      The study duration is 8 weeks, with a 2 week period of screening and baseline, followed by 4
      weeks of 5 daily treatments and 2 weeks of biweekly treatments. Mood and mental state will be
      carefully monitored through standard psychological scales and assessments during the
      screening and baseline and throughout treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: HDRS-21 Score Change From Baseline
time frame: Week 6 post randomization
description: Change from baseline in HDRS-21 scores at week 6 post-randomization in the H7 group compared to the H1 group
measure: Response Rate in HDRS-21
time frame: Week 6 post randomization
description: Percentage of patients with reduction in HDRS-21 score from baseline in the H7 group compared to the H1 group
measure: Remission Rate
time frame: Week 6 post randomization
description: Percentage of patients in remission, at week 6 post-randomization assessment
arm group label: H1-Coil
arm group type: Active Comparator
description: Device: Brainsway H1-Coil Deep TMS System. An FDA cleared deep transcranial magnetic stimulation device. The coil is designed to allow deeper brain stimulation in the lateral prefrontal cortex, including the anterior cingulated cortex without a significant increase of electric fields induced in superficial cortical regions.
arm group label: H7-Coil
arm group type: Experimental
description: Device: Brainsway H7-Coil Deep TMS System. A deep transcranial magnetic stimulation device. The coil is designed to allow deeper brain stimulation in the medial prefrontal cortex, including the anterior cingulated cortex without a significant increase of electric fields induced in superficial cortical regions.
intervention type: Device
intervention name: H7-Coil
description: Deep transcranial magnetic stimulation for the treatment of major dispersion disorder with the H7-Coil
arm group label: H7-Coil
intervention type: Device
intervention name: H1-Coil
description: Deep transcranial magnetic stimulation for the treatment of major depression disorder with the FDA cleared H1-Coil
arm group label: H1-Coil
criteria: 
gender: All
minimum age: 22 Years
maximum age: 68 Years
healthy volunteers: No
last name: Amit Ezra
phone: +972-503103134
email: amite@brainsway.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: Canada
country: Israel
country: United States
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major