<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/NCT02246244</url>
  </required_header>
  <id_info>
    <org_study_id>2008-002159-25</org_study_id>
    <secondary_id>2008/1388</secondary_id>
    <nct_id>NCT02246244</nct_id>
  </id_info>
  <brief_title>Randomized, Double Blind, Efficacy Study of Escitalopram in ENT Cancer Patients Suffering From Emotional Distress</brief_title>
  <acronym>TADDOR</acronym>
  <official_title>Randomized, Double Blind, Efficacy Study of Escitalopram Versus Placebo in ENT Cancer Patients Suffering From Emotional Distress</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gustave Roussy, Cancer Campus, Grand Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gustave Roussy, Cancer Campus, Grand Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Escitalopram is an antidepressant inhibitor of the serotonin reuptake. On the market in&#xD;
      France since 2002.&#xD;
&#xD;
      Prevalence of emotional distress in patients with cancer is 30-50%. this prevalence may vary&#xD;
      regarding the tumor localisation, the population, intensity of the symptoms...&#xD;
&#xD;
      Incidence of ENT cancer is highly significant in France, it is one of the most important in&#xD;
      the world 37 out of 100 000. it is in patients with ENT cancer that the prevalence of&#xD;
      depression is the most important (22%-57%).&#xD;
&#xD;
      Researches appears necessary to assessed the efficacy of antidepressant treatments with as&#xD;
      primary objective not only the decrease of depressive symptoms but also an ensemble of physic&#xD;
      and psychological symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2009</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of treatment by Escitalopram on depressive symptoms</measure>
    <time_frame>Assessed 3 months after randomization</time_frame>
    <description>Assessed using HADS scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy of treatment on emotional distress</measure>
    <time_frame>Assessed 3 months after randomization</time_frame>
    <description>Assessed using HADS scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>ENT Cancer</condition>
  <arm_group>
    <arm_group_label>Escitalopram</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 mg once per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Escitalopram</intervention_name>
    <arm_group_label>Escitalopram</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with ENT cancer of stage I to IVb that have to go under surgery and/or&#xD;
             radiotherapy and/or chemotherapy as first line treatment. It may be a primary cancer&#xD;
             or a new localisation.&#xD;
&#xD;
          -  Total score on HADS scale &gt;11&#xD;
&#xD;
          -  Patients aged from 18 to 75 years&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  OMS &lt; 2, hospitalized or ambulatory&#xD;
&#xD;
          -  Are authorized to inclusion, psychoactive treatments at stable dosage for two weeks&#xD;
             for benzodiazepins, neuroleptics, antihistaminics or other anxiolytics or hypnotics&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in palliative treatments&#xD;
&#xD;
          -  Previous bipolar disorder or schizophrenia&#xD;
&#xD;
          -  Major depressive episode with severity criteria&#xD;
&#xD;
          -  Suicidal patients&#xD;
&#xD;
          -  Acute infection&#xD;
&#xD;
          -  ASAT/ALAT &gt;3N&#xD;
&#xD;
          -  Creatinine clearance &lt;30 ml/mn&#xD;
&#xD;
          -  Natremia inferior to the laboratory standard&#xD;
&#xD;
          -  For alcoholic patients non abstinent at the time of inclusion, previous &quot;delirium&#xD;
             tremens&quot;&#xD;
&#xD;
          -  Previous upper gist bleeding&#xD;
&#xD;
          -  Inefficacy or intolerance of previous treatment by escitalopram&#xD;
&#xD;
          -  Not compatible concomitant treatment:&#xD;
&#xD;
          -  Other antidepressive than escitalopram (except clonazepam)&#xD;
&#xD;
          -  all hypnotics (except zolpidem)&#xD;
&#xD;
          -  all anxiolytics (except clonazepam, clorazepate and diazepam)&#xD;
&#xD;
          -  medical treatment for smoking addiction like bupropion or varenicline&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Patients under guardianship&#xD;
&#xD;
          -  Patients without insurance&#xD;
&#xD;
          -  Impossibility to follow the protocol for geographical, social or psychic reasons&#xD;
&#xD;
          -  Insufficient knowledge of French&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <state>Val de Marne</state>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>June 9, 2016</last_update_submitted>
  <last_update_submitted_qc>June 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 10, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Escitalopram</mesh_term>
  </intervention_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/NCT02246244
org study id: 2008-002159-25
secondary id: 2008/1388
nct id: NCT02246244
lead sponsor: 
has dmc: No
Escitalopram is an antidepressant inhibitor of the serotonin reuptake. On the market in
      France since 2002.

      Prevalence of emotional distress in patients with cancer is 30-50%. this prevalence may vary
      regarding the tumor localisation, the population, intensity of the symptoms...

      Incidence of ENT cancer is highly significant in France, it is one of the most important in
      the world 37 out of 100 000. it is in patients with ENT cancer that the prevalence of
      depression is the most important (22%-57%).

      Researches appears necessary to assessed the efficacy of antidepressant treatments with as
      primary objective not only the decrease of depressive symptoms but also an ensemble of physic
      and psychological symptoms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Efficacy of treatment by Escitalopram on depressive symptoms
time frame: Assessed 3 months after randomization
description: Assessed using HADS scale
measure: Efficacy of treatment on emotional distress
time frame: Assessed 3 months after randomization
description: Assessed using HADS scale
arm group label: Escitalopram
arm group type: Experimental
description: 10 mg once per day
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Escitalopram
arm group label: Escitalopram
intervention type: Other
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Escitalopram