<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/NCT03832218</url>
  </required_header>
  <id_info>
    <org_study_id>49RC19_0004</org_study_id>
    <nct_id>NCT03832218</nct_id>
  </id_info>
  <brief_title>Executive Function Disorders and Anxio-depressive Symptomatology in Children and Adolescents With Mitochondrial Pathologies</brief_title>
  <acronym>MITOPSY</acronym>
  <official_title>Executive Function Disorders and Anxio-depressive Symptomatology in Children and Adolescents With Mitochondrial Pathologies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</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 major steps forward of the neurosciences in recent years have linked psychiatric&#xD;
      diseases, neuropsychological symptoms and brain dysfunctions. The cerebral functioning&#xD;
      requiring a big quantity of energy, mitochondria, essential organelles in the cellular energy&#xD;
      processes, are at present considered as a way of research for big interest in neurology and&#xD;
      in psychiatry. Thus, an increasing number of studies describe potential links between&#xD;
      mitochondrial dysfunction and psychiatric symptomatology. The clinical symptomatology of&#xD;
      children with mitochondrial cytopathy is varied. Well described neurologically and&#xD;
      somatically, it is significantly less in its psychiatric aspects. However, psychiatric&#xD;
      symptoms are frequently associated and this symptom has already been described in adult&#xD;
      patients. The symptoms mainly include depressive and anxiety disorders, or even tables&#xD;
      suggestive of psychotic disorders, which would precede the diagnosis of mitochondrial disease&#xD;
      of 13 years on average.&#xD;
&#xD;
      Neuropsychological disorders refer to disorders of the higher functions following a cerebral&#xD;
      anomaly (language, praxis, motricity, gnosis, visual spatial processing, memory, attention,&#xD;
      intelligence, executive functions ...). Tests validated in French and adapted to children and&#xD;
      adolescents can identify neuropsychological disorders in these populations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2, 2019</start_date>
  <completion_date type="Actual">February 27, 2020</completion_date>
  <primary_completion_date type="Actual">February 27, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of the psychiatric disorders in a population of children reached of mitochondrial disease</measure>
    <time_frame>Day 1</time_frame>
    <description>Psychiatric assessment and neuropsychological tests&#xD;
Test : Wechsler Intelligence Scale for Children (WISC-V) Test :Behavior Rating Inventory of Executive Function (BRIEF) : BRIEF-Parents, BRIEF-Teacher Global Assessment of Functioning Scale Scale : Brief Psychiatric Rating Scale (BPRS) Test : Children Depression Inventory (CDI) Scale : Revised-Children's Manifest Anxiety Scale (R-CMAS) Survey : Pediatric Quality of Life Inventory Version 4.0 (PedsQL™ 4.0) Scale : Conners' scale (parents and teachers)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Mitochondrial Diseases</condition>
  <arm_group>
    <arm_group_label>Mitochondrial disease</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Psychiatric assessment</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Psychiatric assessment</intervention_name>
    <description>Psychiatric assessment and neuropsychological tests&#xD;
Test : Wechsler Intelligence Scale for Children (WISC-V)&#xD;
Test :Behavior Rating Inventory of Executive Function (BRIEF) : BRIEF-Parents, BRIEF-Teacher&#xD;
Global Assessment of Functioning Scale&#xD;
Scale : Brief Psychiatric Rating Scale (BPRS)&#xD;
Test : Children Depression Inventory (CDI)&#xD;
Scale : Revised-Children's Manifest Anxiety Scale (R-CMAS)&#xD;
Survey : Pediatric Quality of Life Inventory Version 4.0 (PedsQL™ 4.0)&#xD;
Scale : Conners' scale (parents and teachers)</description>
    <arm_group_label>Mitochondrial disease</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child with mitochondrial cytopathy (defined by the presence of a mutation known to&#xD;
             cause mitochondrial cytopathy or mitochondrial respiratory chain abnormality)&#xD;
&#xD;
          -  Aged 6 to 17 years&#xD;
&#xD;
          -  Beneficiary of a Social Security regime&#xD;
&#xD;
          -  Parents sign consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child refusal to participate in the study&#xD;
&#xD;
          -  Complete inability to complete questionnaires (e.g. non-communicating child)&#xD;
&#xD;
          -  Child already included in intervention research modifying care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dr RIQUIN Elise</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>November 9, 2020</last_update_submitted>
  <last_update_submitted_qc>November 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2020</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>Mitochondrial Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03832218
org study id: 49RC19_0004
nct id: NCT03832218
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The major steps forward of the neurosciences in recent years have linked psychiatric
      diseases, neuropsychological symptoms and brain dysfunctions. The cerebral functioning
      requiring a big quantity of energy, mitochondria, essential organelles in the cellular energy
      processes, are at present considered as a way of research for big interest in neurology and
      in psychiatry. Thus, an increasing number of studies describe potential links between
      mitochondrial dysfunction and psychiatric symptomatology. The clinical symptomatology of
      children with mitochondrial cytopathy is varied. Well described neurologically and
      somatically, it is significantly less in its psychiatric aspects. However, psychiatric
      symptoms are frequently associated and this symptom has already been described in adult
      patients. The symptoms mainly include depressive and anxiety disorders, or even tables
      suggestive of psychotic disorders, which would precede the diagnosis of mitochondrial disease
      of 13 years on average.

      Neuropsychological disorders refer to disorders of the higher functions following a cerebral
      anomaly (language, praxis, motricity, gnosis, visual spatial processing, memory, attention,
      intelligence, executive functions ...). Tests validated in French and adapted to children and
      adolescents can identify neuropsychological disorders in these populations.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Prevalence of the psychiatric disorders in a population of children reached of mitochondrial disease
time frame: Day 1
description: Psychiatric assessment and neuropsychological tests
Test : Wechsler Intelligence Scale for Children (WISC-V) Test :Behavior Rating Inventory of Executive Function (BRIEF) : BRIEF-Parents, BRIEF-Teacher Global Assessment of Functioning Scale Scale : Brief Psychiatric Rating Scale (BPRS) Test : Children Depression Inventory (CDI) Scale : Revised-Children's Manifest Anxiety Scale (R-CMAS) Survey : Pediatric Quality of Life Inventory Version 4.0 (PedsQL™ 4.0) Scale : Conners' scale (parents and teachers)
arm group label: Mitochondrial disease
arm group type: Other
description: Psychiatric assessment
intervention type: Diagnostic Test
intervention name: Psychiatric assessment
description: Psychiatric assessment and neuropsychological tests
Test : Wechsler Intelligence Scale for Children (WISC-V)
Test :Behavior Rating Inventory of Executive Function (BRIEF) : BRIEF-Parents, BRIEF-Teacher
Global Assessment of Functioning Scale
Scale : Brief Psychiatric Rating Scale (BPRS)
Test : Children Depression Inventory (CDI)
Scale : Revised-Children's Manifest Anxiety Scale (R-CMAS)
Survey : Pediatric Quality of Life Inventory Version 4.0 (PedsQL™ 4.0)
Scale : Conners' scale (parents and teachers)
arm group label: Mitochondrial disease
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Mitochondrial Diseases
sharing ipd: Undecided