<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/NCT04481165</url>
  </required_header>
  <id_info>
    <org_study_id>APHP200104</org_study_id>
    <nct_id>NCT04481165</nct_id>
  </id_info>
  <brief_title>Experience of Adolescents With Anorexia Nervosa Towards Antidepressants</brief_title>
  <acronym>E3A</acronym>
  <official_title>Subjective Experience of Adolescents Suffering From Anorexia Nervosa With Antidepressants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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 explore the experience of adolescents suffering from anorexia&#xD;
      nervosa confronted with the prescription of antidepressants&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In our adolescent psychiatric unit, antidepressant's prescription is common during the care&#xD;
      pathway for adolescents with anorexia nervosa.&#xD;
&#xD;
      The literature highlights a paradox between scientific data and clinical practice, based on&#xD;
      expert consensus. There are a very few qualitative studies in this subject and none of them&#xD;
      concern adolescents.&#xD;
&#xD;
      The purpose of this qualitative study is to explore the experience and opinion of adolescents&#xD;
      suffering from anorexia nervosa confronted with the prescription of antidepressants&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2020</start_date>
  <completion_date type="Actual">October 20, 2020</completion_date>
  <primary_completion_date type="Actual">October 20, 2020</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>Qualitative data / Experience of taking anidepressants</measure>
    <time_frame>At the time of inclusion (Day 0)</time_frame>
    <description>Subjective experience of adolescents with anorexia nervosa about prescription of antidepressants and their effects will be obtained during the grid interview and through their describing to written questions</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Adolescents Cared for Anorexia Nervosa at Maison de Solenn</condition>
  <arm_group>
    <arm_group_label>Adolescents with anorexia nervosa</arm_group_label>
    <description>Adolescents from 12 to 25 year old, cared for anorexia nervosa at the Maison de Solenn (Cochin hospital, Paris, France) et for whom antidepressive agents have been prescribed</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey</intervention_name>
    <description>Oral interview and written questions</description>
    <arm_group_label>Adolescents with anorexia nervosa</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adolescents (between 12 and 25 years) suffer from anorexia nervosa, at the Maison de&#xD;
        Solenn, Cochin Hospital, Paris, France&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescents aged 12 to 25&#xD;
&#xD;
          -  Suffering from anorexia nervosa [according to DSM-5 criteria]&#xD;
&#xD;
          -  Has been prescribed for a type of SSRIs antidepressant (still ongoing or interrupted&#xD;
             at the time of the interview)&#xD;
&#xD;
          -  Non-opposition to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Atypical eating disorder that do not meet DSM-5 criteria for restrictive anorexia&#xD;
             nervosa&#xD;
&#xD;
          -  Body Mass Index &lt; 15&#xD;
&#xD;
          -  Prescribed for another antidepressant than SSRIs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maude LUDOT, Psychiatrist</last_name>
    <role>Principal Investigator</role>
    <affiliation>APHP, Hôpital Cochin, Maison de Solenn, F-75014 Paris, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marie-Rose MORO, PU-PH</last_name>
    <role>Study Chair</role>
    <affiliation>APHP, Hôpital Cochin, Maison de Solenn, F-75014 Paris, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Corinne BLANCHET, PH</last_name>
    <role>Study Director</role>
    <affiliation>APHP, Hôpital Cochin, Maison de Solenn, F-75014 Paris, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jonathan LACHAL, PHU</last_name>
    <role>Study Director</role>
    <affiliation>APHP, Hôpital Cochin, Maison de Solenn, F-75014 Paris, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maison de Solenn / Cochin Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Leble N, Radon L, Rabot M, Godart N. [Depressive symptoms during anorexia nervosa: State of the art and consequences for an appropriate use of antidepressants]. Encephale. 2017 Feb;43(1):62-68. doi: 10.1016/j.encep.2016.02.017. Epub 2016 Jul 21. French.</citation>
    <PMID>27452149</PMID>
  </reference>
  <reference>
    <citation>Anderson C, Roy T. Patient experiences of taking antidepressants for depression: a secondary qualitative analysis. Res Social Adm Pharm. 2013 Nov-Dec;9(6):884-902. doi: 10.1016/j.sapharm.2012.11.002. Epub 2012 Dec 4.</citation>
    <PMID>23219056</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anorexia nervosa</keyword>
  <keyword>Adolescents</keyword>
  <keyword>Antidepressive agents</keyword>
  <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>Yes</sharing_ipd>
    <ipd_description>Use of a treatment database, named Actipidos&#xD;
Interview recording on a Dictaphone [kept all over the study in a locked drawer in a medical office at the Maison de Solenn, and then destroyed].&#xD;
Verbatim transcription, on a word-formatted file from a computer in a medical office at the Maison de Solenn; computer secured by a password.&#xD;
Transcripts will be anonymized with an identical number as soon as they are created; no non-anonymized data records will be kept beyond the end of the study.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>6 months after publication</ipd_time_frame>
    <ipd_access_criteria>Interviews will be analysed with a qualitative methodology (Interpretative Phenomenological Analysis)&#xD;
- Emergent themes will be presented.</ipd_access_criteria>
  </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/NCT04481165
org study id: APHP200104
nct id: NCT04481165
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to explore the experience of adolescents suffering from anorexia
      nervosa confronted with the prescription of antidepressants
In our adolescent psychiatric unit, antidepressant's prescription is common during the care
      pathway for adolescents with anorexia nervosa.

      The literature highlights a paradox between scientific data and clinical practice, based on
      expert consensus. There are a very few qualitative studies in this subject and none of them
      concern adolescents.

      The purpose of this qualitative study is to explore the experience and opinion of adolescents
      suffering from anorexia nervosa confronted with the prescription of antidepressants
observational model: Cohort
time perspective: Prospective
measure: Qualitative data / Experience of taking anidepressants
time frame: At the time of inclusion (Day 0)
description: Subjective experience of adolescents with anorexia nervosa about prescription of antidepressants and their effects will be obtained during the grid interview and through their describing to written questions
arm group label: Adolescents with anorexia nervosa
description: Adolescents from 12 to 25 year old, cared for anorexia nervosa at the Maison de Solenn (Cochin hospital, Paris, France) et for whom antidepressive agents have been prescribed
intervention type: Other
intervention name: Survey
description: Oral interview and written questions
arm group label: Adolescents with anorexia nervosa
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 25 Years
healthy volunteers: No
last name: Maude LUDOT, Psychiatrist
role: Principal Investigator
affiliation: APHP, Hôpital Cochin, Maison de Solenn, F-75014 Paris, France
last name: Marie-Rose MORO, PU-PH
role: Study Chair
affiliation: APHP, Hôpital Cochin, Maison de Solenn, F-75014 Paris, France
last name: Corinne BLANCHET, PH
role: Study Director
affiliation: APHP, Hôpital Cochin, Maison de Solenn, F-75014 Paris, France
last name: Jonathan LACHAL, PHU
role: Study Director
affiliation: APHP, Hôpital Cochin, Maison de Solenn, F-75014 Paris, France
facility: 
country: France
citation: Leble N, Radon L, Rabot M, Godart N. [Depressive symptoms during anorexia nervosa: State of the art and consequences for an appropriate use of antidepressants]. Encephale. 2017 Feb;43(1):62-68. doi: 10.1016/j.encep.2016.02.017. Epub 2016 Jul 21. French.
PMID: 27452149
citation: Anderson C, Roy T. Patient experiences of taking antidepressants for depression: a secondary qualitative analysis. Res Social Adm Pharm. 2013 Nov-Dec;9(6):884-902. doi: 10.1016/j.sapharm.2012.11.002. Epub 2012 Dec 4.
PMID: 23219056
responsible party type: Sponsor
mesh term: Anorexia
mesh term: Anorexia Nervosa
sharing ipd: Yes
ipd description: Use of a treatment database, named Actipidos
Interview recording on a Dictaphone [kept all over the study in a locked drawer in a medical office at the Maison de Solenn, and then destroyed].
Verbatim transcription, on a word-formatted file from a computer in a medical office at the Maison de Solenn; computer secured by a password.
Transcripts will be anonymized with an identical number as soon as they are created; no non-anonymized data records will be kept beyond the end of the study.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: 6 months after publication
ipd access criteria: Interviews will be analysed with a qualitative methodology (Interpretative Phenomenological Analysis)
- Emergent themes will be presented.