<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/NCT03275545</url>
  </required_header>
  <id_info>
    <org_study_id>PSYCH-2017-25878</org_study_id>
    <nct_id>NCT03275545</nct_id>
  </id_info>
  <brief_title>Neural Correlates of Reward and Symptom Expression in Anorexia Nervosa</brief_title>
  <official_title>Neural Correlates of Reward and Symptom Expression in Anorexia Nervosa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</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 objective of this study is to identify the patterns of brain activity in reward circuitry&#xD;
      that promote symptoms of anorexia nervosa. This project will compare weight-restored&#xD;
      individuals with anorexia nervosa to a non-eating disorder control group on reward brain&#xD;
      circuitry patterns in response to typically rewarding cues (i.e., entertaining videos) and&#xD;
      disorder-specific restrictive eating cues (i.e., low-fat food choice) using fMRI. In&#xD;
      addition, this study will examine which neurobiological reward responses among&#xD;
      weight-restored individuals with anorexia nervosa predict objective restrictive eating&#xD;
      (measured by laboratory meal intake) and longitudinal risk of relapse one year later.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim 1: To compare patterns of brain activity in reward circuits to typically rewarding cues&#xD;
      and disorder-specific cues between weight-restored individuals with anorexia nervosa and&#xD;
      non-eating disorder controls&#xD;
&#xD;
      Hypothesis 1a: Activity in reward circuitry will be elevated in response to typically&#xD;
      rewarding cues in the non-eating disorder control group versus weight-restored anorexia&#xD;
      nervosa group.&#xD;
&#xD;
      Hypothesis 1b: Activity in reward circuitry will be elevated in response to disorder-specific&#xD;
      in the weight-restored anorexia nervosa group versus the non-eating disorder control group.&#xD;
&#xD;
      Aim 2: To specify the relationship between brain patterns related to reward and restrictive&#xD;
      eating among weight-restored individuals with anorexia nervosa&#xD;
&#xD;
      Hypothesis 2a: Lower reward circuit activity in response to typically rewarding cues will&#xD;
      predict lower test meal intake for weight-restored anorexia nervosa group versus the&#xD;
      non-eating disorder control group.&#xD;
&#xD;
      Hypothesis 2b: Higher reward circuit activity in response to disorder-specific cues will&#xD;
      predict lower test meal intake for the weight-restored anorexia nervosa group versus the&#xD;
      non-eating disorder control group.&#xD;
&#xD;
      Aim 3: To identify the brain patterns in reward circuitry associated with the risk of relapse&#xD;
      among weight-restored individuals with anorexia nervosa in the year following&#xD;
      weight-restoration.&#xD;
&#xD;
      Hypothesis 3a: Lower reward circuit activity in response to typically rewarding cues will&#xD;
      predict relapse in the weight-restored anorexia nervosa group.&#xD;
&#xD;
      Hypothesis 3b: Higher reward circuit activity in response to disorder-specific cues will&#xD;
      predict relapse in the weight-restored anorexia nervosa group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 28, 2018</start_date>
  <completion_date type="Actual">August 1, 2022</completion_date>
  <primary_completion_date type="Actual">July 12, 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>Brain activation in reward circuits</measure>
    <time_frame>Baseline</time_frame>
    <description>Activation in regions of interest in reward brain circuitry (i.e., ventral tegmental area, nucleus accumbens) in response to typically-rewarding and disorder-specific tasks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Restrictive eating</measure>
    <time_frame>Baseline</time_frame>
    <description>Caloric consumption from a laboratory test meal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse</measure>
    <time_frame>12 months</time_frame>
    <description>Relapse from anorexia nervosa, defined as: BMI &lt; 18.5 kg/m2 and/or binge eating and/or purging &gt; 1x/week for 3 consecutive months</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">79</enrollment>
  <condition>Anorexia Nervosa</condition>
  <arm_group>
    <arm_group_label>Anorexia Nervosa, Weight Restored</arm_group_label>
    <description>Individuals with a recent diagnosis of anorexia nervosa (within the past 6 months), who currently have their weight in a healthy range (BMI &gt; or = 18.5 kg/m2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-eating disorder Control</arm_group_label>
    <description>Individuals without a history of an eating disorder and no current DSM-5 psychiatric diagnoses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention is being examined in this study</description>
    <arm_group_label>Anorexia Nervosa, Weight Restored</arm_group_label>
    <arm_group_label>Non-eating disorder Control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Many participants will be community individuals self-referred to participate through a&#xD;
        flyer or other study advertisement. Individuals who are patients at The Emily Program&#xD;
        eating disorder treatment facility who are in the process of weight-restoration or who have&#xD;
        recently been weight-restored from anorexia nervosa may also be presented with a flyer by&#xD;
        clinical staff at the program through the process outlined above. Participants will also be&#xD;
        recruited from logs of individuals who had previously participated in studies in our lab&#xD;
        and stated that they would like to be contacted for future studies and our active&#xD;
        recruitment log.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years old&#xD;
&#xD;
          -  Current BMI &gt; 18.5 kg/m2&#xD;
&#xD;
          -  Ability to read and speak in English&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
          -  Weight restored Anorexia Nervosa group: 1) DSM-5 diagnosis of AN in the past 6 months,&#xD;
             with the exception of body image disturbance and intense fear of weight gain criteria;&#xD;
             2) BMI &lt; 18.5 kg/m2 within past 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical instability or current pregnancy&#xD;
&#xD;
          -  Current substance use disorder, psychosis, or bipolar-I disorder&#xD;
&#xD;
          -  Contraindication for fMRI&#xD;
&#xD;
          -  History of neurological disorder/injury (e.g., stroke; head injury with &gt; 10 minutes&#xD;
             loss of consciousness)&#xD;
&#xD;
          -  Food allergy that cannot be accommodated through substitutions to the laboratory test&#xD;
             meal&#xD;
&#xD;
          -  Lacking capacity to consent&#xD;
&#xD;
          -  Non-eating disorder Control group: Current DSM-5 Axis-I diagnosis or current or past&#xD;
             eating disorder diagnosis&#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>Ann Haynos, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>September 18, 2022</last_update_submitted>
  <last_update_submitted_qc>September 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anorexia</mesh_term>
    <mesh_term>Anorexia 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/NCT03275545
org study id: PSYCH-2017-25878
nct id: NCT03275545
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to identify the patterns of brain activity in reward circuitry
      that promote symptoms of anorexia nervosa. This project will compare weight-restored
      individuals with anorexia nervosa to a non-eating disorder control group on reward brain
      circuitry patterns in response to typically rewarding cues (i.e., entertaining videos) and
      disorder-specific restrictive eating cues (i.e., low-fat food choice) using fMRI. In
      addition, this study will examine which neurobiological reward responses among
      weight-restored individuals with anorexia nervosa predict objective restrictive eating
      (measured by laboratory meal intake) and longitudinal risk of relapse one year later.
Aim 1: To compare patterns of brain activity in reward circuits to typically rewarding cues
      and disorder-specific cues between weight-restored individuals with anorexia nervosa and
      non-eating disorder controls

      Hypothesis 1a: Activity in reward circuitry will be elevated in response to typically
      rewarding cues in the non-eating disorder control group versus weight-restored anorexia
      nervosa group.

      Hypothesis 1b: Activity in reward circuitry will be elevated in response to disorder-specific
      in the weight-restored anorexia nervosa group versus the non-eating disorder control group.

      Aim 2: To specify the relationship between brain patterns related to reward and restrictive
      eating among weight-restored individuals with anorexia nervosa

      Hypothesis 2a: Lower reward circuit activity in response to typically rewarding cues will
      predict lower test meal intake for weight-restored anorexia nervosa group versus the
      non-eating disorder control group.

      Hypothesis 2b: Higher reward circuit activity in response to disorder-specific cues will
      predict lower test meal intake for the weight-restored anorexia nervosa group versus the
      non-eating disorder control group.

      Aim 3: To identify the brain patterns in reward circuitry associated with the risk of relapse
      among weight-restored individuals with anorexia nervosa in the year following
      weight-restoration.

      Hypothesis 3a: Lower reward circuit activity in response to typically rewarding cues will
      predict relapse in the weight-restored anorexia nervosa group.

      Hypothesis 3b: Higher reward circuit activity in response to disorder-specific cues will
      predict relapse in the weight-restored anorexia nervosa group.
observational model: Case-Control
time perspective: Prospective
measure: Brain activation in reward circuits
time frame: Baseline
description: Activation in regions of interest in reward brain circuitry (i.e., ventral tegmental area, nucleus accumbens) in response to typically-rewarding and disorder-specific tasks
measure: Restrictive eating
time frame: Baseline
description: Caloric consumption from a laboratory test meal
measure: Relapse
time frame: 12 months
description: Relapse from anorexia nervosa, defined as: BMI < 18.5 kg/m2 and/or binge eating and/or purging > 1x/week for 3 consecutive months
arm group label: Anorexia Nervosa, Weight Restored
description: Individuals with a recent diagnosis of anorexia nervosa (within the past 6 months), who currently have their weight in a healthy range (BMI > or = 18.5 kg/m2)
arm group label: Non-eating disorder Control
description: Individuals without a history of an eating disorder and no current DSM-5 psychiatric diagnoses.
intervention type: Other
intervention name: No intervention
description: No intervention is being examined in this study
arm group label: Anorexia Nervosa, Weight Restored
arm group label: Non-eating disorder Control
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: Ann Haynos, PhD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anorexia
mesh term: Anorexia Nervosa