xml: <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/NCT05964023</url>
    </required_header>
    <id_info>
      <org_study_id>CPLMDDDLV5cm</org_study_id>
      <nct_id>NCT05964023</nct_id>
    </id_info>
    <brief_title>pBFS Guided VS &quot;5-cm Rule&quot; rTMS Over DLPFC for MDD</brief_title>
    <official_title>Personalized Brain Functional Sector-guided rTMS Therapy Targeting DLPFC VS &quot;5-centimeter Rule&quot; for Major Depression</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Changping Laboratory</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Changping Laboratory</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>
        The investigators aim to investigate whether the intervention effect of pBFS-guided rTMS&#xD;
        therapy targeting DLPFC is superior to the intervention effect of the traditional &quot;5 cm-rule&quot;&#xD;
        guided rTMS therapy in patients with depressive disorders.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After being informed about the study and potential risks. All patients giving written&#xD;
        informed consent will undergo a screening period to determine eligibility for study entry. At&#xD;
        week 0, patients who meet the eligibility requirements will be randomized in a blind manner&#xD;
        in a 1:1 ratio to the pBFS group, or 5-cm rule group. Then all participants will undergo a&#xD;
        21-day rTMS modulation and 7-day, 14-day, and 45-day post-treatment follow-up visits.&#xD;
        Participants will not take any other treatment during the intervention and the 7-day and&#xD;
        14-day post-treatment visits.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 20, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2024</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores</measure>
      <time_frame>Baseline and Day 21</time_frame>
      <description>The MADRS is a validated instrument stratifying the severity of depressive episodes in adults. The MADRS has an overall score ranging from 0 (no depression) to 60 (worst depression).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>changes in MADRS</measure>
      <time_frame>Baseline, Day 7, Day 14, Day 21 (immediate post-treatment), 7-day post-treatment, 14-day post-treatment, 45-day post-treatment</time_frame>
      <description>The MADRS is a validated instrument stratifying the severity of depressive episodes in adults. The MADRS has an overall score ranging from 0 (no depression) to 60 (worst depression).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>changes in HAMD</measure>
      <time_frame>Baseline, Day 7, Day 14, Day 21 (immediate post-treatment), 7-day post-treatment, 14-day post-treatment, 45-day post-treatment</time_frame>
      <description>The Hamilton Depression Rating Scale (HAMD) is the most widely used clinician-administered depression assessment scale. The HAMD-17 version consists of 17 items，and has an overall score ranging from 0 (no depression) to 52 (worst depression). Higher scores represent higher depression severity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>cognitive change in Digit Symbol Substitution Test (DSST)</measure>
      <time_frame>Baseline, Day 21 (Immediate Post-treatment)</time_frame>
      <description>Cognitive scores are measured using Chinese brief cognitive test (C-BCT), the DSST equires a subject to match symbols to numbers according to a key located on the top of the page</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>cognitive change in continuous performance test (CPT)</measure>
      <time_frame>Baseline, Day 21 (Immediate Post-treatment)</time_frame>
      <description>CPT from the C-BCT measures a person's sustained and selective attention</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>cognitive change in Trail-Making Test (TMT)</measure>
      <time_frame>Baseline, Day 21 (Immediate Post-treatment)</time_frame>
      <description>The TMT test from the C-BCT can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>cognitive change in Digit Span Test (DST)</measure>
      <time_frame>Baseline, Day 21 (Immediate Post-treatment)</time_frame>
      <description>DST from the C-BCT is a measure of verbal short term and working memory that can be used in two formats, Forward Digit Span and Reverse Digit Span</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Major Depression</condition>
    <condition>MDD</condition>
    <arm_group>
      <arm_group_label>pBFS rTMS</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>3 sessions of active rTMS would be delivered to the pBFS-guided left DLPFC daily, with a session of 1800 pulse.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>5-cm rTMS</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>3 sessions of active rTMS would be delivered to the &quot;5-cm rule&quot; guided left DLPFC daily, with a session of 1800 pulse.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>pBFS rTMS</intervention_name>
      <description>Participants will receive 3 sessions per day of 1800 pulses per session, lasting for 21 days. Individualized targets will be generated using the pBFS method.</description>
      <arm_group_label>pBFS rTMS</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>5-cm rTMS</intervention_name>
      <description>Participants will receive 3 sessions per day of 1800 pulses per session, lasting for 21 days. Individualized targets will be localized by &quot;5-cm rule&quot;.</description>
      <arm_group_label>5-cm rTMS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Meet the diagnostic criteria of DSM-5(Diagnostic and Statistical Manual of Mental&#xD;
               Disorders, Fifth Edition) for the depression disorder without psychotic symptoms, and&#xD;
               currently experiencing recurrence episodes.&#xD;
  &#xD;
            -  Inpatients or outpatients aged 18-65 years (inclusive), male or female.&#xD;
  &#xD;
            -  Total HAMD-17 score ≥20 before randomization.Total MADRS score ≥25 before&#xD;
               randomization.&#xD;
  &#xD;
            -  Inadequate response to at least one antidepressant trial of adequate doses and&#xD;
               duration.&#xD;
  &#xD;
            -  Currently not taking any antidepressant medication. If previously medicated, a washout&#xD;
               period of 7 days is required.&#xD;
  &#xD;
            -  Voluntarily participate in the trial and sign informed consent. Able to comply with&#xD;
               the planned visit, examination and treatment plan, and other study procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Meet DSM-5 diagnostic criteria for other mental disorders (such as schizophrenia&#xD;
               spectrum disorders, bipolar and related disorders, neurodevelopmental disorders,&#xD;
               neurocognitive disorders, or depressive disorders due to substances and/or&#xD;
               medications, depressive disorders due to other medical problems, etc.);&#xD;
  &#xD;
            -  Patients with a cardiac pacemaker, cochlear implant, or other metal foreign body and&#xD;
               any electronic equipment implanted in the body, patients with claustrophobia and other&#xD;
               contraindications to magnetic resonance scanning, and patients with contraindications&#xD;
               to rTMS treatment;&#xD;
  &#xD;
            -  Patients with serious or unstable diseases of the cardiovascular, liver, kidney,&#xD;
               blood, endocrine, neurological system, and other systems or organs, especially those&#xD;
               with organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain&#xD;
               tumor, etc.) and a history of severe brain trauma as judged by the researcher;&#xD;
  &#xD;
            -  History of epilepsy (presence of at least 2 uninduced seizures more than 24 hours&#xD;
               apart, or diagnosis of the epileptic syndrome, or seizures within the past 12 months);&#xD;
               Or currently received medications or other treatments that will lower the seizure&#xD;
               threshold;&#xD;
  &#xD;
            -  History of ECT, rTMS, VNS, DBS, tDCS, light therapy, or other physical therapy related&#xD;
               to mental illness within 3 months;&#xD;
  &#xD;
            -  Currently receiving or planning to start formal cognitive or behavioral therapy, or&#xD;
               systemic psychological therapy (interpersonal therapy, dynamic therapy, cognitive&#xD;
               behavioral therapy, etc.) during the trial.&#xD;
  &#xD;
            -  Substance abuse or dependence (including alcohol, drugs, and other psychoactive&#xD;
               substances) in the past 1 year;&#xD;
  &#xD;
            -  The female of childbearing potential plans to become pregnant during the trial and the&#xD;
               female that is pregnant or breastfeeding.&#xD;
  &#xD;
            -  Patients in any clinical trials of other drugs or physical therapy within 1 month&#xD;
               before the screening.&#xD;
  &#xD;
            -  First-degree relatives have bipolar affective disorder.&#xD;
  &#xD;
            -  There is a significant risk of suicide (MADRS item 10 ≥ 5).&#xD;
  &#xD;
            -  Difficulty or inability to engage in normal communication, understand or follow&#xD;
               instructions, and cooperate with treatment and evaluators.&#xD;
  &#xD;
            -  Investigators think that was inappropriate to participate.&#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>Hesheng Liu, Ph.D.</last_name>
      <role>Study Chair</role>
      <affiliation>Changping Laboratory</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Meiling Li, Ph.D.</last_name>
      <phone>010-80726688</phone>
      <email>meilingli@cpl.ac.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hebei Mental Health Center</name>
        <address>
          <city>Baoding</city>
          <state>Hebei</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Bing Li</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Henan Mental Hospital</name>
        <address>
          <city>Xinxiang</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yongfeng Yang, M.D</last_name>
        <phone>15836109413</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Tianjin general hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>chunshui yu</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hangzhou Seventh People's Hospital</name>
        <address>
          <city>Hanzhou</city>
          <state>Zhejiang</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Wei Deng</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Major Depression, MDD</keyword>
    <keyword>pBFS,</keyword>
    <keyword>5cm rule</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>
  
  
text: 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/NCT05964023
  org study id: CPLMDDDLV5cm
  nct id: NCT05964023
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators aim to investigate whether the intervention effect of pBFS-guided rTMS
        therapy targeting DLPFC is superior to the intervention effect of the traditional "5 cm-rule"
        guided rTMS therapy in patients with depressive disorders.
  After being informed about the study and potential risks. All patients giving written
        informed consent will undergo a screening period to determine eligibility for study entry. At
        week 0, patients who meet the eligibility requirements will be randomized in a blind manner
        in a 1:1 ratio to the pBFS group, or 5-cm rule group. Then all participants will undergo a
        21-day rTMS modulation and 7-day, 14-day, and 45-day post-treatment follow-up visits.
        Participants will not take any other treatment during the intervention and the 7-day and
        14-day post-treatment visits.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores
  time frame: Baseline and Day 21
  description: The MADRS is a validated instrument stratifying the severity of depressive episodes in adults. The MADRS has an overall score ranging from 0 (no depression) to 60 (worst depression).
  measure: changes in MADRS
  time frame: Baseline, Day 7, Day 14, Day 21 (immediate post-treatment), 7-day post-treatment, 14-day post-treatment, 45-day post-treatment
  description: The MADRS is a validated instrument stratifying the severity of depressive episodes in adults. The MADRS has an overall score ranging from 0 (no depression) to 60 (worst depression).
  measure: changes in HAMD
  time frame: Baseline, Day 7, Day 14, Day 21 (immediate post-treatment), 7-day post-treatment, 14-day post-treatment, 45-day post-treatment
  description: The Hamilton Depression Rating Scale (HAMD) is the most widely used clinician-administered depression assessment scale. The HAMD-17 version consists of 17 items，and has an overall score ranging from 0 (no depression) to 52 (worst depression). Higher scores represent higher depression severity.
  measure: cognitive change in Digit Symbol Substitution Test (DSST)
  time frame: Baseline, Day 21 (Immediate Post-treatment)
  description: Cognitive scores are measured using Chinese brief cognitive test (C-BCT), the DSST equires a subject to match symbols to numbers according to a key located on the top of the page
  measure: cognitive change in continuous performance test (CPT)
  time frame: Baseline, Day 21 (Immediate Post-treatment)
  description: CPT from the C-BCT measures a person's sustained and selective attention
  measure: cognitive change in Trail-Making Test (TMT)
  time frame: Baseline, Day 21 (Immediate Post-treatment)
  description: The TMT test from the C-BCT can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning
  measure: cognitive change in Digit Span Test (DST)
  time frame: Baseline, Day 21 (Immediate Post-treatment)
  description: DST from the C-BCT is a measure of verbal short term and working memory that can be used in two formats, Forward Digit Span and Reverse Digit Span
  arm group label: pBFS rTMS
  arm group type: Experimental
  description: 3 sessions of active rTMS would be delivered to the pBFS-guided left DLPFC daily, with a session of 1800 pulse.
  arm group label: 5-cm rTMS
  arm group type: Active Comparator
  description: 3 sessions of active rTMS would be delivered to the "5-cm rule" guided left DLPFC daily, with a session of 1800 pulse.
  intervention type: Device
  intervention name: pBFS rTMS
  description: Participants will receive 3 sessions per day of 1800 pulses per session, lasting for 21 days. Individualized targets will be generated using the pBFS method.
  arm group label: pBFS rTMS
  intervention type: Device
  intervention name: 5-cm rTMS
  description: Participants will receive 3 sessions per day of 1800 pulses per session, lasting for 21 days. Individualized targets will be localized by "5-cm rule".
  arm group label: 5-cm rTMS
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Hesheng Liu, Ph.D.
  role: Study Chair
  affiliation: Changping Laboratory
  last name: Meiling Li, Ph.D.
  phone: 010-80726688
  email: meilingli@cpl.ac.cn
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Depressive Disorder, Major