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/NCT06013384</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00128763</org_study_id>
      <nct_id>NCT06013384</nct_id>
    </id_info>
    <brief_title>Low-Intensity Focused Ultrasound for Treatment-Resistant Depression</brief_title>
    <official_title>Clinical Feasibility of Low Intensity Focused Ultrasound Pulsation for the Treatment of Treatment Resistant Major Depressive Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of South Carolina</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medical University of South Carolina</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The Investigators are proposing to demonstrate safety and efficacy of LIFUP for treatment&#xD;
        resistant major depressive disorder in a ten-patient pilot study. LIFUP is an emerging&#xD;
        treatment with the advantage of being able to target subcortical transcranial targets, which&#xD;
        may have superior efficacy or a shorter treatment course compared to other available&#xD;
        treatments such as transcranial magnetic stimulation. This study will investigate the effect&#xD;
        of this stimulation on the left subgenual cingulate cortex, a highly connected node in the&#xD;
        depression network that is correlated with clinical symptomatology.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this pilot study is to evaluate safety and efficacy of a novel treatment, low&#xD;
        intensity focused ultrasound pulsation (LIFUP) for treatment resistant depression (TRD).&#xD;
        Participants will receive either LIFUP or sham stimulation with crossover of sham&#xD;
        participants into the treatment group halfway through the treatment course. The initial visit&#xD;
        will involve consent and an MRI scan, followed by several more either active or sham&#xD;
        treatments outside of the MRI environment delivered over the course of two days over one&#xD;
        week. Response and potential side effects will be monitored pre- and post- each treatment&#xD;
        along with one week and one month follow-up assessments.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Montgomery-Asberg Depression Rating Scale (MADRS) Score Change</measure>
      <time_frame>One week post-treatment</time_frame>
      <description>Change in the MADRS score, which ranges from 0-60, with 0-8 = no depression; 9-17 = mild; 18-34 = moderate; and &gt;35 = severe</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire (PHQ-9) Score Change</measure>
      <time_frame>One week post-treatment</time_frame>
      <description>Change in PHQ-9 Score, which ranges from 0-27, with 0-4 = no depression; 5-9 = mild; 10-14 = moderate; and &gt;15 = severe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General Anxiety Disorder (GAD-7) Score Change</measure>
      <time_frame>One week post-treatment</time_frame>
      <description>Change in GAD-7 Score, which ranges from 0-21, with 0-4 = no anxiety; 5-9 = mild; 10-14 = moderate; and &gt;15 = severe</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Major Depressive Disorder</condition>
    <condition>Treatment Resistant Depression</condition>
    <arm_group>
      <arm_group_label>Active/Active Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will receive eight total treatments of LIFUP across two days one week apart (four treatments each day).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham/Active Group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>This group will receive sham LIFUP for four treatments over one day, followed by four total treatments of active LIFUP across one day one week after sham.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Low-Intensity Focused Ultrasound Pulsation</intervention_name>
      <description>Low-intensity focused ultrasound pulsation will be directed towards the target region at FDA-approved intensity levels in treatment sessions one and two.</description>
      <arm_group_label>Active/Active Group</arm_group_label>
      <arm_group_label>Sham/Active Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sham Low-Intensity Focused Ultrasound Pulsation</intervention_name>
      <description>Sham low-intensity focused ultrasound pulsation will be given.</description>
      <arm_group_label>Sham/Active Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Male or female&#xD;
  &#xD;
            -  Age 18-70&#xD;
  &#xD;
            -  Normal or corrected-to normal vision and hearing&#xD;
  &#xD;
            -  Primary diagnosis of major depressive disorder, moderate/severe per DSM-5 (MADRS &gt;20)&#xD;
  &#xD;
            -  The duration of the illness must exceed one year&#xD;
  &#xD;
            -  Must be medically stable as determined by investigator&#xD;
  &#xD;
            -  Patient must have attempted and failed treatment with at least 2 SSRI and 1&#xD;
               augmentation&#xD;
  &#xD;
            -  History of rTMS is permitted, but not required&#xD;
  &#xD;
          Exclusionary criteria:&#xD;
  &#xD;
            -  Diagnosis of primary DSM-5 depressive disorder other than MDD&#xD;
  &#xD;
            -  Anxiety disorders such as GAD are permitted as long as MDD is primary&#xD;
  &#xD;
            -  Diagnosis of schizophrenia or bipolar disorder&#xD;
  &#xD;
            -  Current use of any non-prescribed psychoactive medications or drugs (aside from&#xD;
               medications for treatment of MDD)&#xD;
  &#xD;
            -  Contraindication to enter the MRI environment.&#xD;
  &#xD;
            -  Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short&#xD;
               term).&#xD;
  &#xD;
            -  Urine Pregnancy Test: If the subject is a woman of childbearing potential and /or a&#xD;
               man capable of fathering a child before, during, and/or after participation precaution&#xD;
               should be taken. Examples of acceptable methods of birth control for participants&#xD;
               involved in the study includes: birth control pills, patch, IUD, condom, sponge,&#xD;
               diaphragm with spermicide, or avoiding sexual activity that could cause the subject to&#xD;
               become pregnant.&#xD;
  &#xD;
            -  Inability to adhere to treatment schedule.&#xD;
  &#xD;
            -  Initiation of new antidepressant treatment at the time of study randomization.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
      <investigator_full_name>Charles Palmer</investigator_full_name>
      <investigator_title>Primary Investigator, Combined Neurology-Psychiatry Resident</investigator_title>
    </responsible_party>
    <keyword>focused ultrasound</keyword>
    <keyword>neuromodulation</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>
      <mesh_term>Depressive Disorder, Treatment-Resistant</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/NCT06013384
  org study id: Pro00128763
  nct id: NCT06013384
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  The Investigators are proposing to demonstrate safety and efficacy of LIFUP for treatment
        resistant major depressive disorder in a ten-patient pilot study. LIFUP is an emerging
        treatment with the advantage of being able to target subcortical transcranial targets, which
        may have superior efficacy or a shorter treatment course compared to other available
        treatments such as transcranial magnetic stimulation. This study will investigate the effect
        of this stimulation on the left subgenual cingulate cortex, a highly connected node in the
        depression network that is correlated with clinical symptomatology.
  The purpose of this pilot study is to evaluate safety and efficacy of a novel treatment, low
        intensity focused ultrasound pulsation (LIFUP) for treatment resistant depression (TRD).
        Participants will receive either LIFUP or sham stimulation with crossover of sham
        participants into the treatment group halfway through the treatment course. The initial visit
        will involve consent and an MRI scan, followed by several more either active or sham
        treatments outside of the MRI environment delivered over the course of two days over one
        week. Response and potential side effects will be monitored pre- and post- each treatment
        along with one week and one month follow-up assessments.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Montgomery-Asberg Depression Rating Scale (MADRS) Score Change
  time frame: One week post-treatment
  description: Change in the MADRS score, which ranges from 0-60, with 0-8 = no depression; 9-17 = mild; 18-34 = moderate; and >35 = severe
  measure: Patient Health Questionnaire (PHQ-9) Score Change
  time frame: One week post-treatment
  description: Change in PHQ-9 Score, which ranges from 0-27, with 0-4 = no depression; 5-9 = mild; 10-14 = moderate; and >15 = severe
  measure: General Anxiety Disorder (GAD-7) Score Change
  time frame: One week post-treatment
  description: Change in GAD-7 Score, which ranges from 0-21, with 0-4 = no anxiety; 5-9 = mild; 10-14 = moderate; and >15 = severe
  arm group label: Active/Active Group
  arm group type: Experimental
  description: This group will receive eight total treatments of LIFUP across two days one week apart (four treatments each day).
  arm group label: Sham/Active Group
  arm group type: Other
  description: This group will receive sham LIFUP for four treatments over one day, followed by four total treatments of active LIFUP across one day one week after sham.
  intervention type: Device
  intervention name: Low-Intensity Focused Ultrasound Pulsation
  description: Low-intensity focused ultrasound pulsation will be directed towards the target region at FDA-approved intensity levels in treatment sessions one and two.
  arm group label: Active/Active Group
  arm group label: Sham/Active Group
  intervention type: Device
  intervention name: Sham Low-Intensity Focused Ultrasound Pulsation
  description: Sham low-intensity focused ultrasound pulsation will be given.
  arm group label: Sham/Active Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Medical University of South Carolina
  investigator full name: Charles Palmer
  investigator title: Primary Investigator, Combined Neurology-Psychiatry Resident
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Depressive Disorder, Major
  mesh term: Depressive Disorder, Treatment-Resistant