<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/NCT02997475</url>
  </required_header>
  <id_info>
    <org_study_id>151514</org_study_id>
    <secondary_id>F32MH108311</secondary_id>
    <nct_id>NCT02997475</nct_id>
  </id_info>
  <brief_title>Neural Bases of Multiple Forms of Self-regulatory Control in Bulimia Nervosa</brief_title>
  <acronym>SRBN</acronym>
  <official_title>Neural Bases of Multiple Forms of Self-regulatory Control in Bulimia Nervosa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Hilda &amp; Preston Davis Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Diego</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate areas of the brain responsible for&#xD;
      self-regulation in adult women who have never had an eating disorder with women who have&#xD;
      bulimia nervosa. More specifically, investigators are interested in changes in brain&#xD;
      activation (e.g., changes in blood flow and oxygen use) when inhibiting responses and&#xD;
      regulating emotions. Data collection will rely on a technology called functional magnetic&#xD;
      resonance imaging (fMRI).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Actual">July 31, 2022</completion_date>
  <primary_completion_date type="Actual">July 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Self-Regulatory Control</measure>
    <time_frame>Day 2 (fMRI Scan)</time_frame>
    <description>Functional Magnetic Resonance Imaging will be used to assess brain activation associated with motor inhibitory control and affect regulation in women with bulimia nervosa (BN)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Goal-Directed Action Control</measure>
    <time_frame>Day 1</time_frame>
    <description>An computerized instrumental learning task will be used to assess performance of women with and without bulimia nervosa.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eating Disorder Relevance</measure>
    <time_frame>Day 0</time_frame>
    <description>The Eating Disorder Examination (EDE) will be conducted to assess relative associations of motor, affective, and goal-directed action control with bulimia nervosa severity.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">89</enrollment>
  <condition>Bulimia Nervosa</condition>
  <arm_group>
    <arm_group_label>Women with Bulimia Nervosa</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Women Healthy Controls</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Women (ages 18-35 years) with bulimia nervosa, and age- and BMI-matched healthy controls.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        General Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
          -  Between the ages of 18 and 35 years&#xD;
&#xD;
             *For Women with Bulimia Nervosa:&#xD;
&#xD;
          -  Binge eating (i.e., eating a large amount of food while experiencing a sense of loss&#xD;
             of control)&#xD;
&#xD;
          -  Purging via self-induced vomiting (other methods may also be endorsed)&#xD;
&#xD;
        General Exclusion Criteria:&#xD;
&#xD;
          -  Current significant medical illness or condition (e.g., diabetes, thyroid disease)&#xD;
&#xD;
          -  Pregnancy, planned pregnancy, or lactation during the study period&#xD;
&#xD;
          -  Non-removable metallic objects in the body&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura A. Berner, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>University of California, San Diego</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSD Eating Disorders Center for Treatment and Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>October 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>January 13, 2023</last_update_submitted>
  <last_update_submitted_qc>January 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 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>Walter Kaye</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Bulimia Nervosa</keyword>
  <keyword>Bulimia</keyword>
  <keyword>fMRI</keyword>
  <keyword>Emotion Regulation</keyword>
  <keyword>Response Inhibition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bulimia</mesh_term>
    <mesh_term>Bulimia Nervosa</mesh_term>
  </condition_browse>
  <!-- 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/NCT02997475
org study id: 151514
secondary id: F32MH108311
nct id: NCT02997475
lead sponsor: 
collaborator: 
collaborator: 
The purpose of this study is to investigate areas of the brain responsible for
      self-regulation in adult women who have never had an eating disorder with women who have
      bulimia nervosa. More specifically, investigators are interested in changes in brain
      activation (e.g., changes in blood flow and oxygen use) when inhibiting responses and
      regulating emotions. Data collection will rely on a technology called functional magnetic
      resonance imaging (fMRI).
observational model: Case-Control
time perspective: Prospective
measure: Self-Regulatory Control
time frame: Day 2 (fMRI Scan)
description: Functional Magnetic Resonance Imaging will be used to assess brain activation associated with motor inhibitory control and affect regulation in women with bulimia nervosa (BN)
measure: Goal-Directed Action Control
time frame: Day 1
description: An computerized instrumental learning task will be used to assess performance of women with and without bulimia nervosa.
measure: Eating Disorder Relevance
time frame: Day 0
description: The Eating Disorder Examination (EDE) will be conducted to assess relative associations of motor, affective, and goal-directed action control with bulimia nervosa severity.
arm group label: Women with Bulimia Nervosa
arm group label: Women Healthy Controls
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Laura A. Berner, Ph.D.
role: Study Director
affiliation: University of California, San Diego
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Walter Kaye
investigator title: Principal Investigator
mesh term: Bulimia
mesh term: Bulimia Nervosa