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/NCT05985356</url>
    </required_header>
    <id_info>
      <org_study_id>RG106837</org_study_id>
      <nct_id>NCT05985356</nct_id>
    </id_info>
    <brief_title>Neuromodulation for Comorbid Hoarding Disorder and Depression</brief_title>
    <official_title>Neuromodulation for Comorbid Hoarding Disorder and Depression</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Diego</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of California, San Diego</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary goal of this study is to evaluate whether intermittent theta burst stimulation&#xD;
        (iTBS) is effective for treating depression in people who have depression and chronic&#xD;
        hoarding disorder (HD). The study will also evaluate whether this treatment can improve HD&#xD;
        symptoms, cognitive performance, and brain region connectivity. The study team will&#xD;
        investigate how the treatment works for depression, as well as other factors that can enhance&#xD;
        or hinder treatment, such as pre-treatment level of depression, cognitive performance, or&#xD;
        brain region connectivity.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 28, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Savings Inventory -- Revised</measure>
      <time_frame>change from baseline to 8 weeks</time_frame>
      <description>self-reported symptoms of hoarding disorder</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hamilton Rating Scale for Depression</measure>
      <time_frame>change from baseline to 8 weeks</time_frame>
      <description>depression symptom severity</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hoarding Rating Scale</measure>
      <time_frame>change from baseline to 8 weeks</time_frame>
      <description>self-reported symptoms of hoarding disorder</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire - 9</measure>
      <time_frame>change from baseline to 8 weeks</time_frame>
      <description>self-reported symptoms of depression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neuropsychological Global Deficit Score</measure>
      <time_frame>change from baseline to 8 weeks</time_frame>
      <description>neurocognition composite</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>resting state functional connectivity</measure>
      <time_frame>change from baseline to 4 weeks</time_frame>
      <description>connectivity between subgenual nucleus accumbens and dorsolateral prefrontal cortex as measured by functional magnetic resonance imaging</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Hoarding Disorder</condition>
    <condition>Hoarding</condition>
    <condition>Depression</condition>
    <arm_group>
      <arm_group_label>iTBS</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>intermittent Theta Burst Stimulation (a form of transcranial magnetic stimulation) targeting the left dorsolateral prefrontal cortex</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>iTBS</intervention_name>
      <description>iTBS targeting the left dorsolateral prefrontal cortex; 20 sessions over 4 weeks.</description>
      <arm_group_label>iTBS</arm_group_label>
      <other_name>rTMS</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Signed and dated informed consent form&#xD;
  &#xD;
            2. Stated willingness to comply with all study procedures and availability for the&#xD;
               duration of the study&#xD;
  &#xD;
            3. Male, female, or non-gender conforming individuals (i.e. those who do not identify as&#xD;
               male or female)&#xD;
  &#xD;
            4. All racial and ethnic groups&#xD;
  &#xD;
            5. Ages 18 to 70&#xD;
  &#xD;
            6. Meets criteria for current Major Depressive Episode within the context of Major&#xD;
               Depressive Disorder, per HAM-D and DIAMOND.&#xD;
  &#xD;
            7. Meets criteria for current Hoarding Disorder, per SIHD&#xD;
  &#xD;
            8. Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive&#xD;
               symptoms&#xD;
  &#xD;
            9. Stable on psychiatric medications for 6 weeks, with no changes to psychiatric&#xD;
               medications expected during the study period&#xD;
  &#xD;
           10. No contraindications to TMS (passes the TMS Adult Safety Screening questionnaire)&#xD;
  &#xD;
           11. No contraindications to MRI (passes MRI safety screening questionnaire)&#xD;
  &#xD;
           12. Able to commit to the treatment schedule&#xD;
  &#xD;
           13. Able to complete assessment procedures in English&#xD;
  &#xD;
           14. Intact decision-making capacity and ability to provide voluntary informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. History of other neurological condition including but not limited to: conditions&#xD;
               associated with increased intracranial pressure; space occupying brain lesions;&#xD;
               cerebral aneurysm; stroke; transient ischemic attack within past two years;&#xD;
               Parkinson's disease; Huntington's disease; dementia; multiple sclerosis; history of&#xD;
               brain surgery; epilepsy; seizure except those therapeutically induced by&#xD;
               electroconvulsive therapy (ECT) or a febrile seizure of infancy&#xD;
  &#xD;
            2. Implanted medical devices that are not explicitly recognized as MRI safe, including&#xD;
               cardiac pacemaker, medication pump, aneurysm clip, shunt, stimulator, cochlear&#xD;
               implant, electrodes, or any other metal object within or near the head (excluding the&#xD;
               mouth) that cannot be safely removed&#xD;
  &#xD;
            3. Active manic or psychotic illness per DIAMOND&#xD;
  &#xD;
            4. Current substance use disorder per DIAMOND&#xD;
  &#xD;
            5. Current active suicidal or spontaneously disclosed homicidal ideation. Active suicidal&#xD;
               ideation for this study is defined as a score of 3 or greater on the HAMD-17 and/or 3&#xD;
               or more on the PHQ-9.&#xD;
  &#xD;
            6. Pregnant or intending to become pregnant within the study period; breastfeeding&#xD;
  &#xD;
            7. Other sensory conditions or illnesses precluding participation in assessments or&#xD;
               treatment&#xD;
  &#xD;
            8. Current dose of lorazepam 2 mg or greater daily (or benzodiazepine equivalent) or any&#xD;
               anticonvulsant due to the potential to limit iTBS efficacy&#xD;
  &#xD;
            9. Taking medication that lowers seizure threshold&#xD;
  &#xD;
           10. Previous failed treatment with rTMS, iTBS, or ECT&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Elizabeth Twamley, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>UC San Diego</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jessica Zakrzewski, PhD</last_name>
      <phone>858-255-1257</phone>
      <email>jzakrzewski@health.ucsd.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>UC San Diego</name>
        <address>
          <city>La Jolla</city>
          <state>California</state>
          <zip>92093</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jessica Zakrzewski, PhD</last_name>
      </contact>
      <investigator>
        <last_name>Elizabeth Twamley, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of California, San Diego</investigator_affiliation>
      <investigator_full_name>Elizabeth Twamley</investigator_full_name>
      <investigator_title>Professor of Psychiatry</investigator_title>
    </responsible_party>
    <keyword>TMS</keyword>
    <keyword>Transcranial magnetic stimulation</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>Hoarding Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data can be de-identified and made available upon request.</ipd_description>
    </patient_data>
    <!-- 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/NCT05985356
  org study id: RG106837
  nct id: NCT05985356
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The primary goal of this study is to evaluate whether intermittent theta burst stimulation
        (iTBS) is effective for treating depression in people who have depression and chronic
        hoarding disorder (HD). The study will also evaluate whether this treatment can improve HD
        symptoms, cognitive performance, and brain region connectivity. The study team will
        investigate how the treatment works for depression, as well as other factors that can enhance
        or hinder treatment, such as pre-treatment level of depression, cognitive performance, or
        brain region connectivity.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Savings Inventory -- Revised
  time frame: change from baseline to 8 weeks
  description: self-reported symptoms of hoarding disorder
  measure: Hamilton Rating Scale for Depression
  time frame: change from baseline to 8 weeks
  description: depression symptom severity
  measure: Hoarding Rating Scale
  time frame: change from baseline to 8 weeks
  description: self-reported symptoms of hoarding disorder
  measure: Patient Health Questionnaire - 9
  time frame: change from baseline to 8 weeks
  description: self-reported symptoms of depression
  measure: Neuropsychological Global Deficit Score
  time frame: change from baseline to 8 weeks
  description: neurocognition composite
  measure: resting state functional connectivity
  time frame: change from baseline to 4 weeks
  description: connectivity between subgenual nucleus accumbens and dorsolateral prefrontal cortex as measured by functional magnetic resonance imaging
  arm group label: iTBS
  arm group type: Experimental
  description: intermittent Theta Burst Stimulation (a form of transcranial magnetic stimulation) targeting the left dorsolateral prefrontal cortex
  intervention type: Device
  intervention name: iTBS
  description: iTBS targeting the left dorsolateral prefrontal cortex; 20 sessions over 4 weeks.
  arm group label: iTBS
  other name: rTMS
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Elizabeth Twamley, PhD
  role: Principal Investigator
  affiliation: UC San Diego
  last name: Jessica Zakrzewski, PhD
  phone: 858-255-1257
  email: jzakrzewski@health.ucsd.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of California, San Diego
  investigator full name: Elizabeth Twamley
  investigator title: Professor of Psychiatry
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Hoarding Disorder
  sharing ipd: No
  ipd description: Data can be de-identified and made available upon request.