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/NCT06002204</url>
    </required_header>
    <id_info>
      <org_study_id>STU-2023-0616</org_study_id>
      <nct_id>NCT06002204</nct_id>
    </id_info>
    <brief_title>Study of Asian Brain and Mind</brief_title>
    <acronym>SABR</acronym>
    <official_title>Study of Asian Brain and Mind (SABR)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Texas Southwestern Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Texas Southwestern Medical Center</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        SABR (from the Urdu word for patience) is a 5-year natural history, longitudinal, prospective&#xD;
        study of a cohort of 6,000 participants that will help uncover the socio-demographic,&#xD;
        lifestyle, clinical, psychological, and neurobiological factors that contribute to&#xD;
        antidepressant treatment response (remission, recurrence, relapse and individual outcomes in&#xD;
        depressive disorders) and resilience. As this is an exploratory study, we will assess a&#xD;
        comprehensive panel of carefully selected participant specific parameters - socio-demographic&#xD;
        (age, sex, gender, race, ethnicity, economic); life habits (physical activity, substance&#xD;
        use); clinical (medical history, anxious depression, early life trauma), biological&#xD;
        (biomarkers in blood, saliva, urine, stool), behavioral (cognitive, emotional),&#xD;
        neurophysiological (EEG), and neuroimaging (magnetic resonance imaging; MRI) with the goal of&#xD;
        developing the most robust predictive models of depression treatment response and of&#xD;
        outcomes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        SABR is a non-randomized, natural history, non-treatment, longitudinal cohort study.&#xD;
        Participants who are receiving standard of care treatment for depression and other&#xD;
        comorbidities from their treating clinician will be allowed to continue such treatments in&#xD;
        this study. There are no experimental study procedures, other than methods used for data&#xD;
        capture (questionnaires, biospecimen collection, EEG, and MRI). Participants will be expected&#xD;
        to visit study site(s) for repeated collection of data (assessments, biospecimens, and&#xD;
        imaging procedures), up to 4 times a year for up to 5 years. A reduced battery of tests is&#xD;
        allowable if subject is not able or willing to complete the full battery after the baseline&#xD;
        visit.&#xD;
  &#xD;
        The primary objective of this initiative is to implement a prospective study that will allow&#xD;
        us to identify and validate biosignatures of 1) response to treatments for depression and&#xD;
        depression outcome and 2) resilience and protective factors that reduce the risk of&#xD;
        developing mood and anxiety disorders (using an integrated array of participant specific&#xD;
        data: socio-demographic, lifestyle, clinical and behavioral assessments, fluid-based&#xD;
        biomarkers, genomics, neuroimaging, EEG, and cell-based assays) in a longitudinal cohort of&#xD;
        Asian American/Pacific Islander (AAPI) participants with elevated symptoms of a depressive&#xD;
        disorder and participants at risk for these illnesses.&#xD;
  &#xD;
        Symptom presence, severity, and remission across various treatment options will be assessed&#xD;
        using questionnaires for symptom changes, antidepressant treatment tolerability and overall&#xD;
        quality of life. Other outcomes generated from this study will include rate of change in&#xD;
        quantitative measures of brain function, of depression relevant brain regions correlated with&#xD;
        systems-levels behavior and other functional neuro-circuitry MRI measures. Rate of change of&#xD;
        specified biochemical biomarkers will also be assessed. Integration of these measures will&#xD;
        provide an unmatched understanding into the mechanisms of depression and hold tremendous&#xD;
        promise for better disease treatment and associated outcomes.&#xD;
  &#xD;
        Integration of these measures will provide an unmatched understanding into the mechanisms of&#xD;
        depression and hold tremendous promise for better disease treatment and associated outcomes.&#xD;
  &#xD;
        Data will be collected from 3 participant groups:&#xD;
  &#xD;
          1. Individuals with a lifetime or a current diagnosis of a mood disorder (based upon a&#xD;
             semi-structured diagnostic interview)&#xD;
  &#xD;
          2. Individuals at risk for developing mood disorders (has history of anxiety disorder,&#xD;
             substance use disorder, trauma, or mood disorder that does not meet criteria for MDD or&#xD;
             Bipolar Disorder or a first-degree relative with a history of mood disorders)&#xD;
  &#xD;
          3. Healthy individuals who do not have a psychiatric diagnosis (including no history of&#xD;
             mood disorders and no relative with a history)&#xD;
  &#xD;
        We also plan to enroll families within and across all three groups. For the purposes of this&#xD;
        study, we are defining family as a group of two or more people related by either birth,&#xD;
        marriage, or adoption, and residing together. Participants may enroll in this study as an&#xD;
        individual or with their family member(s). If participants and their family member(s) are&#xD;
        enrolled together, their study IDs will be linked so that we may group family data.&#xD;
        Participants will NOT be able to see or learn about their family members' data.&#xD;
  &#xD;
        Specific Aims of this Study:&#xD;
  &#xD;
        Aim 1. Create the longitudinal SABR research cohort to support a natural history study of&#xD;
        depression, an important source of knowledge to advance depression understanding and&#xD;
        management among AAPI individuals.&#xD;
  &#xD;
        Aim 2. Establish a SABR biospecimen resource consisting of blood, plasma, serum, PBMCs, DNA,&#xD;
        RNA, saliva, and urine samples collected from participants at study visits as a platform for&#xD;
        translational research into biochemical and molecular characterization of depression.&#xD;
  &#xD;
        Aim 3. Identify neuroimaging and neuropsychiatric parameters that serve as biomarkers or may&#xD;
        be associated with response to specific antidepressant treatment modalities.&#xD;
  &#xD;
        Aim 4. Annually examine biosignatures and independent factors (demographic, social,&#xD;
        environmental, genetic, EEG, fMRI) associated with resilience in at-risk participants to&#xD;
        determine changes and plasticity of biomarkers.&#xD;
  &#xD;
        Aim 5. Examine the interaction between psychiatric symptoms and changes in the&#xD;
        biopsychosocial signature.&#xD;
  &#xD;
        Aim 6. Identify gut microbiome biomarkers that are linked to psychiatric status in&#xD;
        participants with mood disorders.&#xD;
  &#xD;
        Aim 7. Identify the association between participants who are family members to compare&#xD;
        biosignatures of depression and resilience.&#xD;
  &#xD;
        Aim 8. Sub-Study: Evaluate psychological, social, and physiological correlates, from mobile&#xD;
        device-based data, of depression severity and construct a model to estimate mood based on&#xD;
        these measures.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2034</completion_date>
    <primary_completion_date type="Anticipated">December 2033</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>Depression Severity</measure>
      <time_frame>5 years</time_frame>
      <description>Longitudinal changes in depression severity of subjects with elevated symptomatology on Patient Health Questionnaire (PHQ-9) for non-psychotic depressive disorders.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Biomarkers</measure>
      <time_frame>5 years</time_frame>
      <description>Protective factors against developing mood disorders (socio-demographic, lifestyle, clinical and behavioral assessments, fluid-based biomarkers, genomics, neuroimaging (MRI, EEG) and cell-based assays)</description>
    </primary_outcome>
    <other_outcome>
      <measure>Biospecimen Retention</measure>
      <time_frame>Continuous</time_frame>
      <description>Establish a SABR biospecimen resource consisting of blood, plasma, serum, PBMCs, DNA, RNA, saliva, stool, and urine samples collected from subjects at all study visits, as a platform for translational research into biochemical and molecular characterization of depression.</description>
    </other_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">6000</enrollment>
    <condition>Depression</condition>
    <condition>Treatment Resistant Depression</condition>
    <condition>Mood Disorders</condition>
    <condition>Bipolar Disorder</condition>
    <condition>Mental Disorders</condition>
    <condition>Bipolar and Related Disorders</condition>
    <arm_group>
      <arm_group_label>Diagnosed with Mood Disorder</arm_group_label>
      <description>Individuals with a lifetime or a current diagnosis of a mood disorder (based upon a semi-structured diagnostic interview)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>At-risk for Developing Mood Disorder</arm_group_label>
      <description>Individuals at risk for developing mood disorders (has history of anxiety disorder, substance use disorder, trauma, or mood disorder that does not meet criteria for MDD or Bipolar Disorder or a first-degree relative with a history of mood disorders)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy Control</arm_group_label>
      <description>Healthy individuals who do not have a psychiatric diagnosis (including no history of mood disorders and no first-degree relative with a history of mood disorders)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Observational Study</intervention_name>
      <description>No Treatment or Intervention Provided</description>
      <arm_group_label>At-risk for Developing Mood Disorder</arm_group_label>
      <arm_group_label>Diagnosed with Mood Disorder</arm_group_label>
      <arm_group_label>Healthy Control</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Biospecimens collected will be: blood, urine, stool, and saliva.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Participants will be adults or youths aged 10 years and older living in Texas who&#xD;
          self-identify as being of Asian or Pacific Islander descent who have provided informed&#xD;
          consent.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adult or youth aged 10 years or older&#xD;
  &#xD;
            2. Self-identify as being of Asian or Pacific Islander descent (East Asian, South Asian,&#xD;
               Southeast Asian, Southwest Asian, Central Asian, and Oceanian/Pacific Islander)&#xD;
  &#xD;
            3. Have the ability to speak, read, and understand English. The parent(s) or legal&#xD;
               guardians of minors must also speak, read and understand English.&#xD;
  &#xD;
            4. Have the ability to complete clinical evaluations, neuropsychological testing, and&#xD;
               self- report measures.&#xD;
  &#xD;
            5. Meet criteria for one of these three groups:&#xD;
  &#xD;
                 1. Have a lifetime or a current diagnosis of a mood disorder based upon a semi-&#xD;
                    structured diagnostic interview (must be a non-psychotic depressive disorder)&#xD;
  &#xD;
                 2. Be at risk for developing mood disorders (participant has history of anxiety&#xD;
                    disorder, substance use disorder, trauma, or mood disorder that does not meet&#xD;
                    criteria for MDD or Bipolar Disorder, or a first-degree relative with a history&#xD;
                    of mood disorders or suicidal history)&#xD;
  &#xD;
                 3. Healthy Control Group: Have no lifetime history of current diagnosis of a mood&#xD;
                    disorder and no first-degree family member with a history of mood disorder or&#xD;
                    suicidal history&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. History of schizophrenia, schizoaffective disorders or chronic psychotic disorders&#xD;
               based upon a semi-structured diagnostic interview.&#xD;
  &#xD;
               a. For Healthy Control Group: Having a lifetime or a current history of a mood&#xD;
               disorder and no first-degree family member with a history of mood disorder or suicidal&#xD;
               history based upon a semi-structured diagnostic interview.&#xD;
  &#xD;
            2. Unable to provide a stable home address and contact information.&#xD;
  &#xD;
            3. Has any condition for which, in the opinion of the investigator or designee, study&#xD;
               participation would not be in their best interest (including but not limited to&#xD;
               cognitive impairment, unstable general medical condition, intoxication, active&#xD;
               psychosis) or that could prevent, limit, or confound the protocol-specified&#xD;
               assessments.&#xD;
  &#xD;
            4. Requires immediate hospitalization for psychiatric disorder or suicidal risk as&#xD;
               assessed by a licensed study clinician.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Madhukar H Trivedi, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>UT Southwestern</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Afrida Khurshid, BA</last_name>
      <phone>214-998-5877</phone>
      <email>SABR@UTSouthwestern.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sangita Sethuram, MBA, CCRP</last_name>
      <phone>214-648-4357</phone>
      <email>SABR@UTSouthwestern.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sangita Sethuram</name>
        <address>
          <city>Dallas</city>
          <state>Texas</state>
          <zip>75390</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Sangita Sethuram, MBA, CCRP</last_name>
        <phone>214-648-4357</phone>
        <email>SABR@UTSouthwestern.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
      <investigator_full_name>Madhukar H. Trivedi, MD</investigator_full_name>
      <investigator_title>Professor of Psychiatry</investigator_title>
    </responsible_party>
    <keyword>Depression</keyword>
    <keyword>Resilience</keyword>
    <keyword>Asian American &amp; Pacific Islanders</keyword>
    <keyword>Mood Disorders</keyword>
    <keyword>Bipolar Disorder</keyword>
    <keyword>Behavioral Symptoms</keyword>
    <keyword>Observational Study</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>Bipolar Disorder</mesh_term>
      <mesh_term>Mental Disorders</mesh_term>
      <mesh_term>Depressive Disorder, Treatment-Resistant</mesh_term>
      <mesh_term>Mood Disorders</mesh_term>
      <mesh_term>Bipolar and Related Disorders</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/NCT06002204
  org study id: STU-2023-0616
  nct id: NCT06002204
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  SABR (from the Urdu word for patience) is a 5-year natural history, longitudinal, prospective
        study of a cohort of 6,000 participants that will help uncover the socio-demographic,
        lifestyle, clinical, psychological, and neurobiological factors that contribute to
        antidepressant treatment response (remission, recurrence, relapse and individual outcomes in
        depressive disorders) and resilience. As this is an exploratory study, we will assess a
        comprehensive panel of carefully selected participant specific parameters - socio-demographic
        (age, sex, gender, race, ethnicity, economic); life habits (physical activity, substance
        use); clinical (medical history, anxious depression, early life trauma), biological
        (biomarkers in blood, saliva, urine, stool), behavioral (cognitive, emotional),
        neurophysiological (EEG), and neuroimaging (magnetic resonance imaging; MRI) with the goal of
        developing the most robust predictive models of depression treatment response and of
        outcomes.
  SABR is a non-randomized, natural history, non-treatment, longitudinal cohort study.
        Participants who are receiving standard of care treatment for depression and other
        comorbidities from their treating clinician will be allowed to continue such treatments in
        this study. There are no experimental study procedures, other than methods used for data
        capture (questionnaires, biospecimen collection, EEG, and MRI). Participants will be expected
        to visit study site(s) for repeated collection of data (assessments, biospecimens, and
        imaging procedures), up to 4 times a year for up to 5 years. A reduced battery of tests is
        allowable if subject is not able or willing to complete the full battery after the baseline
        visit.
  
        The primary objective of this initiative is to implement a prospective study that will allow
        us to identify and validate biosignatures of 1) response to treatments for depression and
        depression outcome and 2) resilience and protective factors that reduce the risk of
        developing mood and anxiety disorders (using an integrated array of participant specific
        data: socio-demographic, lifestyle, clinical and behavioral assessments, fluid-based
        biomarkers, genomics, neuroimaging, EEG, and cell-based assays) in a longitudinal cohort of
        Asian American/Pacific Islander (AAPI) participants with elevated symptoms of a depressive
        disorder and participants at risk for these illnesses.
  
        Symptom presence, severity, and remission across various treatment options will be assessed
        using questionnaires for symptom changes, antidepressant treatment tolerability and overall
        quality of life. Other outcomes generated from this study will include rate of change in
        quantitative measures of brain function, of depression relevant brain regions correlated with
        systems-levels behavior and other functional neuro-circuitry MRI measures. Rate of change of
        specified biochemical biomarkers will also be assessed. Integration of these measures will
        provide an unmatched understanding into the mechanisms of depression and hold tremendous
        promise for better disease treatment and associated outcomes.
  
        Integration of these measures will provide an unmatched understanding into the mechanisms of
        depression and hold tremendous promise for better disease treatment and associated outcomes.
  
        Data will be collected from 3 participant groups:
  
          1. Individuals with a lifetime or a current diagnosis of a mood disorder (based upon a
             semi-structured diagnostic interview)
  
          2. Individuals at risk for developing mood disorders (has history of anxiety disorder,
             substance use disorder, trauma, or mood disorder that does not meet criteria for MDD or
             Bipolar Disorder or a first-degree relative with a history of mood disorders)
  
          3. Healthy individuals who do not have a psychiatric diagnosis (including no history of
             mood disorders and no relative with a history)
  
        We also plan to enroll families within and across all three groups. For the purposes of this
        study, we are defining family as a group of two or more people related by either birth,
        marriage, or adoption, and residing together. Participants may enroll in this study as an
        individual or with their family member(s). If participants and their family member(s) are
        enrolled together, their study IDs will be linked so that we may group family data.
        Participants will NOT be able to see or learn about their family members' data.
  
        Specific Aims of this Study:
  
        Aim 1. Create the longitudinal SABR research cohort to support a natural history study of
        depression, an important source of knowledge to advance depression understanding and
        management among AAPI individuals.
  
        Aim 2. Establish a SABR biospecimen resource consisting of blood, plasma, serum, PBMCs, DNA,
        RNA, saliva, and urine samples collected from participants at study visits as a platform for
        translational research into biochemical and molecular characterization of depression.
  
        Aim 3. Identify neuroimaging and neuropsychiatric parameters that serve as biomarkers or may
        be associated with response to specific antidepressant treatment modalities.
  
        Aim 4. Annually examine biosignatures and independent factors (demographic, social,
        environmental, genetic, EEG, fMRI) associated with resilience in at-risk participants to
        determine changes and plasticity of biomarkers.
  
        Aim 5. Examine the interaction between psychiatric symptoms and changes in the
        biopsychosocial signature.
  
        Aim 6. Identify gut microbiome biomarkers that are linked to psychiatric status in
        participants with mood disorders.
  
        Aim 7. Identify the association between participants who are family members to compare
        biosignatures of depression and resilience.
  
        Aim 8. Sub-Study: Evaluate psychological, social, and physiological correlates, from mobile
        device-based data, of depression severity and construct a model to estimate mood based on
        these measures.
  observational model: Cohort
  time perspective: Prospective
  measure: Depression Severity
  time frame: 5 years
  description: Longitudinal changes in depression severity of subjects with elevated symptomatology on Patient Health Questionnaire (PHQ-9) for non-psychotic depressive disorders.
  measure: Biomarkers
  time frame: 5 years
  description: Protective factors against developing mood disorders (socio-demographic, lifestyle, clinical and behavioral assessments, fluid-based biomarkers, genomics, neuroimaging (MRI, EEG) and cell-based assays)
  measure: Biospecimen Retention
  time frame: Continuous
  description: Establish a SABR biospecimen resource consisting of blood, plasma, serum, PBMCs, DNA, RNA, saliva, stool, and urine samples collected from subjects at all study visits, as a platform for translational research into biochemical and molecular characterization of depression.
  arm group label: Diagnosed with Mood Disorder
  description: Individuals with a lifetime or a current diagnosis of a mood disorder (based upon a semi-structured diagnostic interview)
  arm group label: At-risk for Developing Mood Disorder
  description: Individuals at risk for developing mood disorders (has history of anxiety disorder, substance use disorder, trauma, or mood disorder that does not meet criteria for MDD or Bipolar Disorder or a first-degree relative with a history of mood disorders)
  arm group label: Healthy Control
  description: Healthy individuals who do not have a psychiatric diagnosis (including no history of mood disorders and no first-degree relative with a history of mood disorders)
  intervention type: Other
  intervention name: Observational Study
  description: No Treatment or Intervention Provided
  arm group label: At-risk for Developing Mood Disorder
  arm group label: Diagnosed with Mood Disorder
  arm group label: Healthy Control
  Biospecimens collected will be: blood, urine, stool, and saliva.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Madhukar H Trivedi, MD
  role: Principal Investigator
  affiliation: UT Southwestern
  last name: Afrida Khurshid, BA
  phone: 214-998-5877
  email: SABR@UTSouthwestern.edu
  last name: Sangita Sethuram, MBA, CCRP
  phone: 214-648-4357
  email: SABR@UTSouthwestern.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Texas Southwestern Medical Center
  investigator full name: Madhukar H. Trivedi, MD
  investigator title: Professor of Psychiatry
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Bipolar Disorder
  mesh term: Mental Disorders
  mesh term: Depressive Disorder, Treatment-Resistant
  mesh term: Mood Disorders
  mesh term: Bipolar and Related Disorders