<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/NCT03841019</url>
  </required_header>
  <id_info>
    <org_study_id>201840269</org_study_id>
    <nct_id>NCT03841019</nct_id>
  </id_info>
  <brief_title>Predict MDE Outcomes After MST</brief_title>
  <official_title>Research on the Prediction of Clinical Response to Magnetic Seizure Therapy for Patients With Major Depression Episode</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Mental Health Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Mental Health Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This trial attempts to explore the treatment outcome of magnetic seizure therapy (MST) for&#xD;
      major depressive episode. Half of the participants will receive MST, while the other half&#xD;
      will receive electroconvulsive therapy (ECT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Magnetic seizure therapy (MST) is likely to be an alternative options to electroconvulsive&#xD;
      therapy (ECT).&#xD;
&#xD;
      Widespread stimulation of cortical and subcortical regions is inevitable for ECT since the&#xD;
      substantial impedance of the scalp and skull shuts most of the electrical stimulus away from&#xD;
      the brain. Nevertheless, magnetic pulses are capable to focus the stimulus to a specific area&#xD;
      of the brain because they can pass the scalp and skull without resistance. In Addition,&#xD;
      electric current will penetrate into deeper structures, while magnetic stimulus are only&#xD;
      capable to reach a depth of a few centimeters. As a consequence, MST are able to generate&#xD;
      focus stimuli on superficial regions of the cortex while ECT can't, which may give MST the&#xD;
      capability to produce comparable therapeutic benefits with the absence of apparent cognitive&#xD;
      side effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 31, 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in the 17-item Hamilton Depression Rating Scale (HAMD-17)</measure>
    <time_frame>At baseline and 4-week follow-up</time_frame>
    <description>The HAMD-17 score ranges from 0 to 52. A higher score indicates a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)</measure>
    <time_frame>At baseline and 4-week follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in the spectral power of the electroencephalogram (EEG) in square microvolt during resting state</measure>
    <time_frame>At baseline and 4-week follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in the spectral power of the electroencephalogram (EEG) in square microvolt during the auditory mismatch negativity task</measure>
    <time_frame>At baseline and 4-week follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in the spectral power of the electroencephalogram (EEG) in square microvolt during the facial recognition task.</measure>
    <time_frame>At baseline and 4-week follow-up</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Major Depressive Episode</condition>
  <arm_group>
    <arm_group_label>magnetic seizure therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 treatment sessions of MST, three times per week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>electroconvulsive therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 treatment sessions of ECT, three times per week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Magpro X100 + Option</intervention_name>
    <description>In addition to treatment as usual (TAU), participants were supposed to receive twelve sessions of MST in four weeks (three sessions per week)</description>
    <arm_group_label>magnetic seizure therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ThymatronSystem Ⅳ Electroconvulsive System</intervention_name>
    <description>In addition to treatment as usual (TAU), participants were supposed to receive twelve sessions of ECT in four weeks (three sessions per week)</description>
    <arm_group_label>electroconvulsive therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. DSM-5 diagnosis of major depressive episode;&#xD;
&#xD;
          2. convulsive therapy clinically indicated, such as severe psychomotor excitement or&#xD;
             retardation, attempts of suicide, being highly aggressive, pharmacotherapy&#xD;
             intolerance, and ineffectiveness of antipsychotics;&#xD;
&#xD;
          3. the HAMD-17 ≥ 24;&#xD;
&#xD;
          4. informed consent in written form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. primary diagnosis of other mental disorders;&#xD;
&#xD;
          2. severe physical diseases, such as stroke, heart failure, liver failure, neoplasm, and&#xD;
             immune deficiency;&#xD;
&#xD;
          3. present with a laboratory abnormality that could impact on efficacy of treatments or&#xD;
             safety of participants;&#xD;
&#xD;
          4. failure to respond to an adequate trial of ECT lifetime;&#xD;
&#xD;
          5. are pregnant or intend to get pregnant during the study;&#xD;
&#xD;
          6. Unremovable metal implants.&#xD;
&#xD;
          7. other conditions that investigators consider to be inappropriate to participate in&#xD;
             this trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianhua Sheng, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Mental Health Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jianhua Sheng, PHD</last_name>
    <phone>86-21-34773759</phone>
    <email>shengjianhua66@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Mental Health Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianhua Sheng, PHD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 22, 2022</last_update_submitted>
  <last_update_submitted_qc>February 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03841019
org study id: 201840269
nct id: NCT03841019
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This trial attempts to explore the treatment outcome of magnetic seizure therapy (MST) for
      major depressive episode. Half of the participants will receive MST, while the other half
      will receive electroconvulsive therapy (ECT).
Magnetic seizure therapy (MST) is likely to be an alternative options to electroconvulsive
      therapy (ECT).

      Widespread stimulation of cortical and subcortical regions is inevitable for ECT since the
      substantial impedance of the scalp and skull shuts most of the electrical stimulus away from
      the brain. Nevertheless, magnetic pulses are capable to focus the stimulus to a specific area
      of the brain because they can pass the scalp and skull without resistance. In Addition,
      electric current will penetrate into deeper structures, while magnetic stimulus are only
      capable to reach a depth of a few centimeters. As a consequence, MST are able to generate
      focus stimuli on superficial regions of the cortex while ECT can't, which may give MST the
      capability to produce comparable therapeutic benefits with the absence of apparent cognitive
      side effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: changes in the 17-item Hamilton Depression Rating Scale (HAMD-17)
time frame: At baseline and 4-week follow-up
description: The HAMD-17 score ranges from 0 to 52. A higher score indicates a worse outcome.
measure: changes in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
time frame: At baseline and 4-week follow-up
measure: changes in the spectral power of the electroencephalogram (EEG) in square microvolt during resting state
time frame: At baseline and 4-week follow-up
measure: changes in the spectral power of the electroencephalogram (EEG) in square microvolt during the auditory mismatch negativity task
time frame: At baseline and 4-week follow-up
measure: changes in the spectral power of the electroencephalogram (EEG) in square microvolt during the facial recognition task.
time frame: At baseline and 4-week follow-up
arm group label: magnetic seizure therapy
arm group type: Experimental
description: 12 treatment sessions of MST, three times per week.
arm group label: electroconvulsive therapy
arm group type: Active Comparator
description: 12 treatment sessions of ECT, three times per week.
intervention type: Device
intervention name: Magpro X100 + Option
description: In addition to treatment as usual (TAU), participants were supposed to receive twelve sessions of MST in four weeks (three sessions per week)
arm group label: magnetic seizure therapy
intervention type: Device
intervention name: ThymatronSystem Ⅳ Electroconvulsive System
description: In addition to treatment as usual (TAU), participants were supposed to receive twelve sessions of ECT in four weeks (three sessions per week)
arm group label: electroconvulsive therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jianhua Sheng, PHD
role: Principal Investigator
affiliation: Shanghai Mental Health Center
last name: Jianhua Sheng, PHD
phone: 86-21-34773759
email: shengjianhua66@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
sharing ipd: No