<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/NCT03304665</url>
  </required_header>
  <id_info>
    <org_study_id>170181</org_study_id>
    <secondary_id>17-M-0181</secondary_id>
    <nct_id>NCT03304665</nct_id>
  </id_info>
  <brief_title>Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies</brief_title>
  <official_title>Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</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>
      Objective: To screen and create a list of adult volunteers in good health for participation&#xD;
      in research studies conducted at the National Institutes of Health (NIH) in Bethesda,&#xD;
      Maryland. Develop a normative set of structural and functional brain MRI scans that are&#xD;
      linked to healthy research volunteer characteristics. Maximize scientific impact of data from&#xD;
      volunteers by broadly sharing with other researchers.&#xD;
&#xD;
      Study Population: Adult males and females in general good health who are 18 years of age and&#xD;
      older.&#xD;
&#xD;
      Design: Adult individuals who are interested in participating in NIMH IRP clinical studies as&#xD;
      a healthy research volunteer can directly visit or be directed to visit the study website&#xD;
      where they will first consent electronically and then complete a set of online self-report&#xD;
      measures. Items may include: demographic information, mental health symptoms, disability&#xD;
      status, substance use patterns, handedness and clinical/family history. Individuals who are&#xD;
      flagged based on predetermined responses to survey items will be further screened by a member&#xD;
      of the study clinical team. If found to be ineligible for the study because of a clinically&#xD;
      significant or unstable medical or mental health condition, these individuals will be&#xD;
      referred back to the community and/or given information about NIMH clinical studies for which&#xD;
      they may be eligible. Respondents with no flags or who pass through additional screening will&#xD;
      be scheduled for an in-person assessment. During the outpatient appointment and after&#xD;
      in-person informed consent, participants will receive a brief clinical interview to screen&#xD;
      for current medical and mental conditions, and risk for self-harm. They will complete&#xD;
      assessments of psychological, emotional, physiologic, biological and cognitive functioning.&#xD;
      Participants will undergo a physical exam and be asked to provide blood and urine samples for&#xD;
      routine clinical labs as well as additional blood samples for future secondary analysis that&#xD;
      could include genetic or biomarker assays. Participants can separately consent for an&#xD;
      optional baseline brain magnetic resonance imaging (MRI) scan and an optional&#xD;
      magnetoencephalography (MEG) exam. All consent forms will explicitly inform participants that&#xD;
      if enrolled in the study, their de-identified data will be broadly and publicly shared&#xD;
      through NIH-approved data repositories. Participants in this recruitment and characterization&#xD;
      study will then be placed on a list of healthy research volunteers from which other NIMH IRP&#xD;
      studies may recruit according to the inclusion and exclusion criteria in their respective&#xD;
      IRB-approved protocols.&#xD;
&#xD;
      Outcome Measures: Outcome measures may include demographic data, mental and medical history&#xD;
      and symptoms, results of psychological, emotional, physiologic, biological, and cognitive&#xD;
      testing, physical exam and MRI findings.&#xD;
&#xD;
      ...&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To screen and create a list of adult volunteers in good health for participation&#xD;
      in research studies conducted at the National Institutes of Health (NIH) in Bethesda,&#xD;
      Maryland. Develop a normative set of structural and functional brain MRI scans that are&#xD;
      linked to healthy research volunteer characteristics. Maximize scientific impact of data from&#xD;
      volunteers by broadly sharing with other researchers.&#xD;
&#xD;
      Study Population: Adult males and females in general good health who are 18 years of age and&#xD;
      older.&#xD;
&#xD;
      Design: Adult individuals who are interested in participating in NIMH IRP clinical studies as&#xD;
      a healthy research volunteer can directly visit or be directed to visit the study website&#xD;
      where they will first consent electronically and then complete a set of online self-report&#xD;
      measures. Items may include: demographic information, mental health symptoms, disability&#xD;
      status, substance use patterns, handedness and clinical/family history. Individuals who are&#xD;
      flagged based on predetermined responses to survey items will be further screened by a member&#xD;
      of the study clinical team. If found to be ineligible for the study because of a clinically&#xD;
      significant or unstable medical or mental health condition, these individuals will be&#xD;
      referred back to the community and/or given information about NIMH clinical studies for which&#xD;
      they may be eligible. Respondents with no flags or who pass through additional screening will&#xD;
      be scheduled for an in-person assessment. During the outpatient appointment and after&#xD;
      in-person informed consent, participants will receive a brief clinical interview to screen&#xD;
      for current medical and mental conditions, and risk for self-harm. They will complete&#xD;
      assessments of psychological, emotional, physiologic, biological and cognitive functioning.&#xD;
      Participants will undergo a physical exam and be asked to provide blood and urine samples for&#xD;
      routine clinical labs as well as additional blood samples for future secondary analysis that&#xD;
      could include genetic or biomarker assays. Participants can separately consent for an&#xD;
      optional baseline brain magnetic resonance imaging (MRI) scan and an optional&#xD;
      magnetoencephalography (MEG) exam. All consent forms will explicitly inform participants that&#xD;
      if enrolled in the study, their de-identified data will be broadly and publicly shared&#xD;
      through NIH-approved data repositories. Participants in this recruitment and characterization&#xD;
      study will then be placed on a list of healthy research volunteers from which other NIMH IRP&#xD;
      studies may recruit according to the inclusion and exclusion criteria in their respective&#xD;
      IRB-approved protocols.&#xD;
&#xD;
      Outcome Measures: Outcome measures may include demographic data, mental and medical history&#xD;
      and symptoms, results of psychological, emotional, physiologic, biological, and cognitive&#xD;
      testing, physical exam and MRI findings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Anticipated">March 1, 2027</completion_date>
  <primary_completion_date type="Actual">April 26, 2023</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Online self-report and in-person assessments that may yield demographic data, mental and medical history and symptoms, results of measures of psychological, emotional, physiologic, biological, and cognitive functioning, and physical or MRI findi...</measure>
    <time_frame>Ongoing</time_frame>
    <description>Online self-report and in-person assessments that may yield demographic data, mental and medical history and symptoms, results of measures of psychological, emotional, physiologic, biological, and cognitive functioning, and physical or MRI findings.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">376</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <description>Healthy Volunteers</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy research volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
               1. 18 years of age and older.&#xD;
&#xD;
               2. Able to read, speak, and understand English.&#xD;
&#xD;
               3. Able to provide informed consent.&#xD;
&#xD;
               4. In current good general health.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          1. Have a history of significant or unstable medical or mental health condition requiring&#xD;
             treatment, such as heart or lung disease, depression or psychosis.&#xD;
&#xD;
          2. Endorse current self-injury, suicidal thoughts or behavior.&#xD;
&#xD;
          3. Have current illicit drug use by history or urine drug screen.&#xD;
&#xD;
          4. Are found to have an abnormal physical exam or laboratory result that may require&#xD;
             treatment or further evaluation.&#xD;
&#xD;
          5. Less than an 8th grade education or an IQ below 70.&#xD;
&#xD;
          6. Are a NIMH employee, staff member, or first degree relative (parent, sibling, child)&#xD;
             of an NIMH employee or staff member.&#xD;
&#xD;
        Optional Brain MRI scan exclusion criteria:&#xD;
&#xD;
          1. Metal in body which would make having an MRI scan unsafe&#xD;
&#xD;
          2. Being uncomfortable in small closed spaces such as the MRI machine&#xD;
&#xD;
          3. Inability to lie comfortably on back for at least 45 minutes&#xD;
&#xD;
          4. Pregnancy&#xD;
&#xD;
        Optional MEG recording exclusion criteria:&#xD;
&#xD;
        1. Metal in body which would cause artifacts on MEG recordings.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joyce Y Chung, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Mental Health (NIMH)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2017-M-0181.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>May 10, 2023</verification_date>
  <study_first_submitted>October 6, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>May 11, 2023</last_update_submitted>
  <last_update_submitted_qc>May 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy Volunteer</keyword>
  <keyword>Mental Health</keyword>
  <keyword>Common Data Elements</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03304665
org study id: 170181
secondary id: 17-M-0181
nct id: NCT03304665
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Objective: To screen and create a list of adult volunteers in good health for participation
      in research studies conducted at the National Institutes of Health (NIH) in Bethesda,
      Maryland. Develop a normative set of structural and functional brain MRI scans that are
      linked to healthy research volunteer characteristics. Maximize scientific impact of data from
      volunteers by broadly sharing with other researchers.

      Study Population: Adult males and females in general good health who are 18 years of age and
      older.

      Design: Adult individuals who are interested in participating in NIMH IRP clinical studies as
      a healthy research volunteer can directly visit or be directed to visit the study website
      where they will first consent electronically and then complete a set of online self-report
      measures. Items may include: demographic information, mental health symptoms, disability
      status, substance use patterns, handedness and clinical/family history. Individuals who are
      flagged based on predetermined responses to survey items will be further screened by a member
      of the study clinical team. If found to be ineligible for the study because of a clinically
      significant or unstable medical or mental health condition, these individuals will be
      referred back to the community and/or given information about NIMH clinical studies for which
      they may be eligible. Respondents with no flags or who pass through additional screening will
      be scheduled for an in-person assessment. During the outpatient appointment and after
      in-person informed consent, participants will receive a brief clinical interview to screen
      for current medical and mental conditions, and risk for self-harm. They will complete
      assessments of psychological, emotional, physiologic, biological and cognitive functioning.
      Participants will undergo a physical exam and be asked to provide blood and urine samples for
      routine clinical labs as well as additional blood samples for future secondary analysis that
      could include genetic or biomarker assays. Participants can separately consent for an
      optional baseline brain magnetic resonance imaging (MRI) scan and an optional
      magnetoencephalography (MEG) exam. All consent forms will explicitly inform participants that
      if enrolled in the study, their de-identified data will be broadly and publicly shared
      through NIH-approved data repositories. Participants in this recruitment and characterization
      study will then be placed on a list of healthy research volunteers from which other NIMH IRP
      studies may recruit according to the inclusion and exclusion criteria in their respective
      IRB-approved protocols.

      Outcome Measures: Outcome measures may include demographic data, mental and medical history
      and symptoms, results of psychological, emotional, physiologic, biological, and cognitive
      testing, physical exam and MRI findings.

      ...
Objective: To screen and create a list of adult volunteers in good health for participation
      in research studies conducted at the National Institutes of Health (NIH) in Bethesda,
      Maryland. Develop a normative set of structural and functional brain MRI scans that are
      linked to healthy research volunteer characteristics. Maximize scientific impact of data from
      volunteers by broadly sharing with other researchers.

      Study Population: Adult males and females in general good health who are 18 years of age and
      older.

      Design: Adult individuals who are interested in participating in NIMH IRP clinical studies as
      a healthy research volunteer can directly visit or be directed to visit the study website
      where they will first consent electronically and then complete a set of online self-report
      measures. Items may include: demographic information, mental health symptoms, disability
      status, substance use patterns, handedness and clinical/family history. Individuals who are
      flagged based on predetermined responses to survey items will be further screened by a member
      of the study clinical team. If found to be ineligible for the study because of a clinically
      significant or unstable medical or mental health condition, these individuals will be
      referred back to the community and/or given information about NIMH clinical studies for which
      they may be eligible. Respondents with no flags or who pass through additional screening will
      be scheduled for an in-person assessment. During the outpatient appointment and after
      in-person informed consent, participants will receive a brief clinical interview to screen
      for current medical and mental conditions, and risk for self-harm. They will complete
      assessments of psychological, emotional, physiologic, biological and cognitive functioning.
      Participants will undergo a physical exam and be asked to provide blood and urine samples for
      routine clinical labs as well as additional blood samples for future secondary analysis that
      could include genetic or biomarker assays. Participants can separately consent for an
      optional baseline brain magnetic resonance imaging (MRI) scan and an optional
      magnetoencephalography (MEG) exam. All consent forms will explicitly inform participants that
      if enrolled in the study, their de-identified data will be broadly and publicly shared
      through NIH-approved data repositories. Participants in this recruitment and characterization
      study will then be placed on a list of healthy research volunteers from which other NIMH IRP
      studies may recruit according to the inclusion and exclusion criteria in their respective
      IRB-approved protocols.

      Outcome Measures: Outcome measures may include demographic data, mental and medical history
      and symptoms, results of psychological, emotional, physiologic, biological, and cognitive
      testing, physical exam and MRI findings.
observational model: Cohort
time perspective: Cross-Sectional
measure: Online self-report and in-person assessments that may yield demographic data, mental and medical history and symptoms, results of measures of psychological, emotional, physiologic, biological, and cognitive functioning, and physical or MRI findi...
time frame: Ongoing
description: Online self-report and in-person assessments that may yield demographic data, mental and medical history and symptoms, results of measures of psychological, emotional, physiologic, biological, and cognitive functioning, and physical or MRI findings.
arm group label: Healthy Volunteers
description: Healthy Volunteers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joyce Y Chung, M.D.
role: Principal Investigator
affiliation: National Institute of Mental Health (NIMH)
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2017-M-0181.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Sponsor