<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/NCT02995226</url>
  </required_header>
  <id_info>
    <org_study_id>D15-P018</org_study_id>
    <nct_id>NCT02995226</nct_id>
  </id_info>
  <brief_title>Abnormal Regulation, Estimation and Cognitive Impacts of Physical Efforts as an Endophenotype of Anorexia Nervosa</brief_title>
  <acronym>CAPANOX</acronym>
  <official_title>Analysis of the Capacity to Regulate Physical Efforts and to Estimate Its Intensity as an Endophenotype of Anorexia Nervosa, Because of a Specific Impact of the Physical Effort at the Emotional, Cognitive, Pain, Genetic and Biological Level</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier St Anne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier St Anne</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 this study is to check if patients, but also relatives (as they share familial&#xD;
      and genetic risk factors), are having more difficulties in regulating a spontaneous, pleasant&#xD;
      physical effort (doing &quot;too much&quot;) compared to healthy controls, and if physical efforts are&#xD;
      participating to core symptoms of anorexia nervosa, such as more appetite (instead of less),&#xD;
      less pain, more abnormal body image, and less cognitive flexibility.&#xD;
&#xD;
      Such a result could help to further understand the role of difficulties with physical&#xD;
      exercise as part of the phenotype of anorexia nervosa.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a three steps protocol. First, patients (with anorexia nervosa), controls (with no&#xD;
      eating disorder) and first degree relatives (with no eating disorder) will be tested for&#xD;
      emotional accuracy (seing faces on a screen with different core emotions), pain threshold&#xD;
      (how long they can support a cold probe), body size (how they see themselves), appetite and&#xD;
      cognitive flexibility (a test where the capacity to change rules during a game is done easily&#xD;
      or not).&#xD;
&#xD;
      Then all subjects will do a standardized physical exercise which represents an effort with&#xD;
      the equivalent level of energy for each participants as being chosen according to each level&#xD;
      of competency (assessed through the &quot;maximal aerobic power&quot;).&#xD;
&#xD;
      The third step consists in the repetition of (nearly) initial tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 27, 2017</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">April 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical power</measure>
    <time_frame>Day 0</time_frame>
    <description>Comparison inter and intra individual of the subjective and objective power to the subjects during a typical physical bike test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain threshold</measure>
    <time_frame>Day 0</time_frame>
    <description>This threshold is based on the minimum temperature that the patient is able to suppor (the probe is placed on the skin of the forarm, and the temperature reduces its temperature every 10 seconds), knowing that the machine is not getting to temperatures that can be damageable.&#xD;
Comparison before and after bike test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wellbeing self-questionnaire</measure>
    <time_frame>Day 0</time_frame>
    <description>Comparison before and after bike test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hunger Visual analogical scale</measure>
    <time_frame>Day 0</time_frame>
    <description>Comparison before and after bike test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PANAS score (self-questionnaire)</measure>
    <time_frame>Day 0</time_frame>
    <description>Emotions. Comparison before and after bike test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hunger Visual analogical scale</measure>
    <time_frame>Day 0</time_frame>
    <description>Apetite. Comparison before and after bike test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance on the Briton cognitive test (number of errors)</measure>
    <time_frame>Day 0</time_frame>
    <description>Mental flexibility. Comparison before and after bike test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance on cognitive tests (speed, number of errors), before versus after the exercise, in the three groups.</measure>
    <time_frame>Day 0</time_frame>
    <description>Tests. Performance on cognitive tests (speed, number of errors), before versus after the exercise, in the three groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genetical analysis</measure>
    <time_frame>Day 0</time_frame>
    <description>10 candidate genes will be analyzed (following the collection of blood or saliva) assessing the frequency of their main alleles (variants), looking for a significant difference of allele frequency between the 3 groups.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Anorexia Nervosa</condition>
  <arm_group>
    <arm_group_label>Anorexia nervosa</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients with DSM-5 criteria of &quot;anorexia nervosa&quot;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>First degree relatives</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>First degree relatives (of patients suffering from anorexia nervosa) with no eating disorder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls (with no eating disorder)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Other</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical and biological examination, Saliva (or blood) test Glycemia, thermal test, cognitive and bike tests, questionnaires</intervention_name>
    <description>Clinical and biological examination, Saliva (or blood) test, glycemia, thermal test, cognitive and bike tests, questionnaires</description>
    <arm_group_label>Anorexia nervosa</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires</intervention_name>
    <description>Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires</description>
    <arm_group_label>Controls (with no eating disorder)</arm_group_label>
    <arm_group_label>First degree relatives</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients :&#xD;
&#xD;
          -  Woman&#xD;
&#xD;
          -  18 - 50 years&#xD;
&#xD;
          -  eating disorders (with or without bulimia) according to the EDI-2 (Eating Disorder&#xD;
             Inventory) and the MINI (Mini International Neuropsychiatric Interview)&#xD;
&#xD;
          -  BMI (Body Mass index) between 14 and 17,5&#xD;
&#xD;
          -  first degree relative without ED (eating disorders)&#xD;
&#xD;
        First degree relatives :&#xD;
&#xD;
          -  Woman&#xD;
&#xD;
          -  18 - 50 years&#xD;
&#xD;
          -  Mother or sister of patient with eating disorders&#xD;
&#xD;
          -  BMI (Body Mass index) upper to 17,5&#xD;
&#xD;
          -  Healthy of all ED (eating disorders)&#xD;
&#xD;
        Controls :&#xD;
&#xD;
          -  Woman&#xD;
&#xD;
          -  18 - 50 years&#xD;
&#xD;
          -  BMI &gt; 17,5&#xD;
&#xD;
          -  Without ED (eating disorders)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        All groups :&#xD;
&#xD;
          -  Contraindication in the practice of an intensive sport&#xD;
&#xD;
          -  Cardiovascular Family history with risk of cardiovascular unwanted events&#xD;
&#xD;
          -  Cardiovascular, surgical personal Histories, ostéoarticulaires or musculo-tendinous&#xD;
             against indicating to the practice of a sport&#xD;
&#xD;
          -  Intercurrents psychiatric pathologies (humor or psychotics disorders, chronic or&#xD;
             acute)&#xD;
&#xD;
        Related and controls :&#xD;
&#xD;
        Diagnosis of ED (eating disorders) in the EDI-2 and in the MINI&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip GORWOOD, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>CHSA</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Philip GORWOOD, MD, PhD</last_name>
    <phone>00 33 45 65 86 39</phone>
    <email>p.gorwood@ch-sainte-anne.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marie GODARD</last_name>
    <phone>00 33 1 45 65 77 28</phone>
    <email>s.dorocant@ch-sainte-anne.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre Hospitalier Sainte Anne</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philip GORWOOD, MD., PhD</last_name>
      <phone>0033 1 45 65 86 39</phone>
      <email>p.gorwood@ch-sainte-anne.fr</email>
    </contact>
    <contact_backup>
      <last_name>Sylvie DOROCANT</last_name>
      <phone>0033 1 45 65 77 28</phone>
      <email>s.dorocant@ch-sainte-anne.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>January 23, 2018</last_update_submitted>
  <last_update_submitted_qc>January 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2018</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02995226
org study id: D15-P018
nct id: NCT02995226
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to check if patients, but also relatives (as they share familial
      and genetic risk factors), are having more difficulties in regulating a spontaneous, pleasant
      physical effort (doing "too much") compared to healthy controls, and if physical efforts are
      participating to core symptoms of anorexia nervosa, such as more appetite (instead of less),
      less pain, more abnormal body image, and less cognitive flexibility.

      Such a result could help to further understand the role of difficulties with physical
      exercise as part of the phenotype of anorexia nervosa.
This is a three steps protocol. First, patients (with anorexia nervosa), controls (with no
      eating disorder) and first degree relatives (with no eating disorder) will be tested for
      emotional accuracy (seing faces on a screen with different core emotions), pain threshold
      (how long they can support a cold probe), body size (how they see themselves), appetite and
      cognitive flexibility (a test where the capacity to change rules during a game is done easily
      or not).

      Then all subjects will do a standardized physical exercise which represents an effort with
      the equivalent level of energy for each participants as being chosen according to each level
      of competency (assessed through the "maximal aerobic power").

      The third step consists in the repetition of (nearly) initial tests.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Physical power
time frame: Day 0
description: Comparison inter and intra individual of the subjective and objective power to the subjects during a typical physical bike test.
measure: Pain threshold
time frame: Day 0
description: This threshold is based on the minimum temperature that the patient is able to suppor (the probe is placed on the skin of the forarm, and the temperature reduces its temperature every 10 seconds), knowing that the machine is not getting to temperatures that can be damageable.
Comparison before and after bike test
measure: Wellbeing self-questionnaire
time frame: Day 0
description: Comparison before and after bike test
measure: Hunger Visual analogical scale
time frame: Day 0
description: Comparison before and after bike test
measure: PANAS score (self-questionnaire)
time frame: Day 0
description: Emotions. Comparison before and after bike test
measure: Hunger Visual analogical scale
time frame: Day 0
description: Apetite. Comparison before and after bike test
measure: Performance on the Briton cognitive test (number of errors)
time frame: Day 0
description: Mental flexibility. Comparison before and after bike test
measure: Performance on cognitive tests (speed, number of errors), before versus after the exercise, in the three groups.
time frame: Day 0
description: Tests. Performance on cognitive tests (speed, number of errors), before versus after the exercise, in the three groups.
measure: Genetical analysis
time frame: Day 0
description: 10 candidate genes will be analyzed (following the collection of blood or saliva) assessing the frequency of their main alleles (variants), looking for a significant difference of allele frequency between the 3 groups.
arm group label: Anorexia nervosa
arm group type: Other
description: Patients with DSM-5 criteria of "anorexia nervosa"
arm group label: First degree relatives
arm group type: Other
description: First degree relatives (of patients suffering from anorexia nervosa) with no eating disorder
arm group label: Controls (with no eating disorder)
arm group type: Other
description: Other
intervention type: Other
intervention name: Clinical and biological examination, Saliva (or blood) test Glycemia, thermal test, cognitive and bike tests, questionnaires
description: Clinical and biological examination, Saliva (or blood) test, glycemia, thermal test, cognitive and bike tests, questionnaires
arm group label: Anorexia nervosa
intervention type: Other
intervention name: Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires
description: Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires
arm group label: Controls (with no eating disorder)
arm group label: First degree relatives
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Philip GORWOOD, MD, PhD
role: Study Chair
affiliation: CHSA
last name: Philip GORWOOD, MD, PhD
phone: 00 33 45 65 86 39
email: p.gorwood@ch-sainte-anne.fr
last name: Marie GODARD
phone: 00 33 1 45 65 77 28
email: s.dorocant@ch-sainte-anne.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Anorexia
mesh term: Anorexia Nervosa
sharing ipd: No