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/NCT06002100</url>
    </required_header>
    <id_info>
      <org_study_id>KER2023-2-PREDICT</org_study_id>
      <nct_id>NCT06002100</nct_id>
    </id_info>
    <brief_title>Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements</brief_title>
    <acronym>PREDICT</acronym>
    <official_title>PREDICT: Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kernel</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kernel</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 purpose of the current study is to perform a unified, homogeneous data collection&#xD;
        protocol that includes a large cohort of patients undergoing different treatment options for&#xD;
        Major Depressive Disorder (MDD) as an avenue for investigating optimal biomarkers for&#xD;
        depression treatments on an individual patient level.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 14, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Brain hemodynamic activity with TD-fNIRS</measure>
      <time_frame>Approximately 30 minutes during each study visit</time_frame>
      <description>This includes changes in the concentration of oxygenated and deoxygenated hemoglobin as measured by the change in light absorption.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Optical properties of the brain with TD-fNIRS</measure>
      <time_frame>Approximately 30 minutes during each study visit</time_frame>
      <description>This measures how much light is absorbed at different points on the head.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physiological features with TD-fNIRS</measure>
      <time_frame>Approximately 30 minutes during each study visit</time_frame>
      <description>This includes cardiac measures, such as heart rate (HR).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physiological features with TD-fNIRS</measure>
      <time_frame>Approximately 30 minutes during each study visit</time_frame>
      <description>This includes cardiac measures, such as heart rate variability (HRV).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Montgomery-Åsberg Depression Rating Scale (MADRS)</measure>
      <time_frame>At baseline and closeout, up to 3 months</time_frame>
      <description>Clinician-rated measure of depressive severity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire (PHQ-9)</measure>
      <time_frame>From baseline to closeout, up to 3 months</time_frame>
      <description>9-item self-report that has been validated as a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General Anxiety Disorder (GAD-7)</measure>
      <time_frame>At baseline and closeout, up to 3 months</time_frame>
      <description>7-item self-report measure used to assess participant anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Snaith-Hamilton Pleasure Scale (SHAPS)</measure>
      <time_frame>At baseline and closeout, up to 3 months</time_frame>
      <description>14-item self-administered questionnaire measuring anhedonia (inability to feel pleasure) through four domains of pleasure response: interest/pastimes, social interaction, sensory experience, and food/drink.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>World Health Organization Quality of Life (WHOQOL-BREF)</measure>
      <time_frame>At baseline and closeout, up to 3 months</time_frame>
      <description>26-item self-report which aims to assess an individual's quality of life. The scale was developed with a cross-cultural approach and covers domains including physical, psychological, social relationships, and environment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Revised Mystical Experience Questionnaire (RMEQ)</measure>
      <time_frame>Visit 2, within approximately 7 days of baseline</time_frame>
      <description>30-item self-report which provides scale scores for four domains: mystical experience, positive mood, transcendence of time and space, and ineffability. Ketamine and SPRAVATO cohorts only.</description>
    </secondary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">540</enrollment>
    <condition>Depression</condition>
    <condition>Major Depressive Disorder</condition>
    <arm_group>
      <arm_group_label>Ketamine</arm_group_label>
      <description>Adult participants starting ketamine treatment for depression at a participating clinic. fNIRS measurements using Kernel Flow2 will be taken at a pre-treatment, early-treatment, and post-treatment visit. No clinical decisions will be made based on the data acquired for this study, and participation in the study has no influence on treatment decisions (including dosage form, frequency, and duration).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SPRAVATO</arm_group_label>
      <description>Adult participants starting SPRAVATO treatment for depression at a participating clinic. fNIRS measurements using Kernel Flow2 will be taken at a pre-treatment, early-treatment, and post-treatment visit. No clinical decisions will be made based on the data acquired for this study, and participation in the study has no influence on treatment decisions (including dosage form, frequency, and duration).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TMS</arm_group_label>
      <description>Adult participants starting TMS treatment for depression at a participating clinic. fNIRS measurements using Kernel Flow2 will be taken at a pre-treatment, early-treatment, and post-treatment visit. No clinical decisions will be made based on the data acquired for this study, and participation in the study has no influence on treatment decisions (including dosage form, frequency, and duration).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Antidepressants</arm_group_label>
      <description>Adult participants starting antidepressant treatment for depression at a participating clinic. fNIRS measurements using Kernel Flow2 will be taken at a pre-treatment and short-term efficacy visit. No clinical decisions will be made based on the data acquired for this study, and participation in the study has no influence on treatment decisions (including dosage form, frequency, and duration).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>fNIRS measurement</intervention_name>
      <description>Kernel Flow2 measurements.</description>
      <arm_group_label>Antidepressants</arm_group_label>
      <arm_group_label>Ketamine</arm_group_label>
      <arm_group_label>SPRAVATO</arm_group_label>
      <arm_group_label>TMS</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult participants seeking treatment for depression at a participating clinic/study site.&#xD;
          Separate cohorts of participants will be enrolled depending on the treatment they have been&#xD;
          prescribed. No clinical decisions will be made based on the data acquired for this study,&#xD;
          and participation in the study has no influence on treatment decisions.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Ketamine cohort&#xD;
  &#xD;
            -  Adult between the ages of 18 - 65, inclusive at time of enrollment&#xD;
  &#xD;
            -  Primary diagnosis of MDD as defined by DSM-5&#xD;
  &#xD;
            -  Determined by clinic to be eligible for ketamine treatment and agrees to receive&#xD;
               ketamine treatment&#xD;
  &#xD;
            -  Agrees to start ketamine treatment in conjunction with study participation to capture&#xD;
               pre-treatment measurements accurately&#xD;
  &#xD;
            -  Has not received a ketamine treatment course in the past 12 months&#xD;
  &#xD;
            -  Has not received a TMS treatment course in the past 3 months&#xD;
  &#xD;
            -  Ability to consent for themselves&#xD;
  &#xD;
            -  Fluency in English (speaking and reading)&#xD;
  &#xD;
          SPRAVATO cohort&#xD;
  &#xD;
            -  Adult between the ages of 18 - 75, inclusive at time of enrollment&#xD;
  &#xD;
            -  Primary diagnosis of MDD as defined by DSM-5&#xD;
  &#xD;
            -  Determined by clinic to be eligible for SPRAVATO treatment and agrees to receive&#xD;
               SPRAVATO treatment&#xD;
  &#xD;
            -  Agrees to start SPRAVATO treatment in conjunction with study participation to capture&#xD;
               pre-treatment measurements accurately&#xD;
  &#xD;
            -  Has not received a ketamine or SPRAVATO treatment course in the past 12 months&#xD;
  &#xD;
            -  Has not received a TMS treatment course in the past 3 months&#xD;
  &#xD;
            -  Ability to consent for themselves&#xD;
  &#xD;
            -  Fluency in English (speaking and reading)&#xD;
  &#xD;
          TMS cohort&#xD;
  &#xD;
            -  Adult between the ages of 18 - 65, inclusive at time of enrollment&#xD;
  &#xD;
            -  Primary diagnosis of MDD as defined by DSM-5&#xD;
  &#xD;
            -  Determined by clinic to be eligible for TMS treatment and agrees to receive TMS&#xD;
               treatment&#xD;
  &#xD;
            -  Agrees to start TMS treatment in conjunction with study participation to capture&#xD;
               pre-treatment measurements accurately&#xD;
  &#xD;
            -  Has not received a TMS treatment course in the past 12 months&#xD;
  &#xD;
            -  Has not received a ketamine or SPRAVATO treatment course within the last 3 months&#xD;
  &#xD;
            -  Ability to consent for themselves&#xD;
  &#xD;
            -  Fluency in English (speaking and reading)&#xD;
  &#xD;
          Antidepressants cohort&#xD;
  &#xD;
            -  Adult between the ages of 18 - 65, inclusive at time of enrollment&#xD;
  &#xD;
            -  Primary diagnosis of MDD as defined by DSM-5&#xD;
  &#xD;
            -  Determined by clinic to be eligible for antidepressant treatment and agrees to receive&#xD;
               antidepressant treatment&#xD;
  &#xD;
            -  Agrees to start antidepressant treatment in conjunction with study participation to&#xD;
               capture pre-treatment measurements accurately&#xD;
  &#xD;
            -  Has not taken antidepressants in the past 3 months&#xD;
  &#xD;
            -  Has not received a TMS, SPRAVATO, or ketamine treatment course in the past 3 months&#xD;
  &#xD;
            -  Ability to consent for themselves&#xD;
  &#xD;
            -  Fluency in English (speaking and reading)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Is or may be pregnant (for participant of childbearing potential [POCBP]), even if&#xD;
               they have been cleared to receive the depression treatment&#xD;
  &#xD;
            -  Unable or unwilling to wear the TD-fNIRS headset&#xD;
  &#xD;
            -  Has had ECT in the past 3 months&#xD;
  &#xD;
            -  Major visual or auditory deficits that would prevent study task completion&#xD;
  &#xD;
            -  Hospitalizations and/or unstable health/medical condition/treatment in the last 30&#xD;
               days&#xD;
  &#xD;
            -  Major medical illnesses and psychiatric conditions including:&#xD;
  &#xD;
                 -  Alzheimer's/Mild Cognitive Impairment&#xD;
  &#xD;
                 -  Parkinson's disease&#xD;
  &#xD;
                 -  Motor neuron diseases&#xD;
  &#xD;
                 -  Multiple Sclerosis&#xD;
  &#xD;
                 -  Brain Tumor&#xD;
  &#xD;
                 -  Stroke&#xD;
  &#xD;
                 -  Encephalitis&#xD;
  &#xD;
                 -  Meningitis&#xD;
  &#xD;
                 -  Epilepsy&#xD;
  &#xD;
                 -  TBI with serious results (coma, unconscious for &gt;2 hrs, or skull fracture)&#xD;
  &#xD;
                 -  Current serious psychiatric conditions (bipolar disorder, schizophrenia, or&#xD;
                    psychosis)&#xD;
  &#xD;
            -  Any other clinically significant medical condition or circumstance that, in the&#xD;
               opinion of the Investigator, could affect patient safety, preclude evaluation of&#xD;
               response, interfere with the ability to comply with study procedures, or prohibit&#xD;
               completion of the study&#xD;
  &#xD;
            -  Not an appropriate candidate for the study in the judgment of the investigator(s)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Katherine Perdue, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Kernel</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Kadima Neuropsychiatry Institute</name>
        <address>
          <city>La Jolla</city>
          <state>California</state>
          <zip>92037</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Bespoke Treatment</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90025</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>ATP Clinical Research</name>
        <address>
          <city>Orange</city>
          <state>California</state>
          <zip>92868</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>functional Near Infrared Spectroscopy (fNIRS)</keyword>
    <keyword>Ketamine</keyword>
    <keyword>SPRAVATO</keyword>
    <keyword>TMS</keyword>
    <keyword>Antidepressants</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>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT06002100
  org study id: KER2023-2-PREDICT
  nct id: NCT06002100
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of the current study is to perform a unified, homogeneous data collection
        protocol that includes a large cohort of patients undergoing different treatment options for
        Major Depressive Disorder (MDD) as an avenue for investigating optimal biomarkers for
        depression treatments on an individual patient level.
  observational model: Cohort
  time perspective: Prospective
  measure: Brain hemodynamic activity with TD-fNIRS
  time frame: Approximately 30 minutes during each study visit
  description: This includes changes in the concentration of oxygenated and deoxygenated hemoglobin as measured by the change in light absorption.
  measure: Optical properties of the brain with TD-fNIRS
  time frame: Approximately 30 minutes during each study visit
  description: This measures how much light is absorbed at different points on the head.
  measure: Physiological features with TD-fNIRS
  time frame: Approximately 30 minutes during each study visit
  description: This includes cardiac measures, such as heart rate (HR).
  measure: Physiological features with TD-fNIRS
  time frame: Approximately 30 minutes during each study visit
  description: This includes cardiac measures, such as heart rate variability (HRV).
  measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
  time frame: At baseline and closeout, up to 3 months
  description: Clinician-rated measure of depressive severity.
  measure: Patient Health Questionnaire (PHQ-9)
  time frame: From baseline to closeout, up to 3 months
  description: 9-item self-report that has been validated as a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression.
  measure: General Anxiety Disorder (GAD-7)
  time frame: At baseline and closeout, up to 3 months
  description: 7-item self-report measure used to assess participant anxiety.
  measure: Snaith-Hamilton Pleasure Scale (SHAPS)
  time frame: At baseline and closeout, up to 3 months
  description: 14-item self-administered questionnaire measuring anhedonia (inability to feel pleasure) through four domains of pleasure response: interest/pastimes, social interaction, sensory experience, and food/drink.
  measure: World Health Organization Quality of Life (WHOQOL-BREF)
  time frame: At baseline and closeout, up to 3 months
  description: 26-item self-report which aims to assess an individual's quality of life. The scale was developed with a cross-cultural approach and covers domains including physical, psychological, social relationships, and environment.
  measure: Revised Mystical Experience Questionnaire (RMEQ)
  time frame: Visit 2, within approximately 7 days of baseline
  description: 30-item self-report which provides scale scores for four domains: mystical experience, positive mood, transcendence of time and space, and ineffability. Ketamine and SPRAVATO cohorts only.
  arm group label: Ketamine
  description: Adult participants starting ketamine treatment for depression at a participating clinic. fNIRS measurements using Kernel Flow2 will be taken at a pre-treatment, early-treatment, and post-treatment visit. No clinical decisions will be made based on the data acquired for this study, and participation in the study has no influence on treatment decisions (including dosage form, frequency, and duration).
  arm group label: SPRAVATO
  description: Adult participants starting SPRAVATO treatment for depression at a participating clinic. fNIRS measurements using Kernel Flow2 will be taken at a pre-treatment, early-treatment, and post-treatment visit. No clinical decisions will be made based on the data acquired for this study, and participation in the study has no influence on treatment decisions (including dosage form, frequency, and duration).
  arm group label: TMS
  description: Adult participants starting TMS treatment for depression at a participating clinic. fNIRS measurements using Kernel Flow2 will be taken at a pre-treatment, early-treatment, and post-treatment visit. No clinical decisions will be made based on the data acquired for this study, and participation in the study has no influence on treatment decisions (including dosage form, frequency, and duration).
  arm group label: Antidepressants
  description: Adult participants starting antidepressant treatment for depression at a participating clinic. fNIRS measurements using Kernel Flow2 will be taken at a pre-treatment and short-term efficacy visit. No clinical decisions will be made based on the data acquired for this study, and participation in the study has no influence on treatment decisions (including dosage form, frequency, and duration).
  intervention type: Other
  intervention name: fNIRS measurement
  description: Kernel Flow2 measurements.
  arm group label: Antidepressants
  arm group label: Ketamine
  arm group label: SPRAVATO
  arm group label: TMS
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Katherine Perdue, PhD
  role: Principal Investigator
  affiliation: Kernel
  facility: 
  facility: 
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Depressive Disorder, Major
  sharing ipd: Undecided