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Executive Function Disorders and Anxio-depressive Symptomatology in Children and Adolescents With Mitochondrial Pathologies (MITOPSY)

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ClinicalTrials.gov Identifier: NCT03832218
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Mitochondrial Diseases Diagnostic Test: Psychiatric assessment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Executive Function Disorders and Anxio-depressive Symptomatology in Children and Adolescents With Mitochondrial Pathologies
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020


Arm Intervention/treatment
Mitochondrial disease
Psychiatric assessment
Diagnostic Test: Psychiatric assessment

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)




Primary Outcome Measures :
  1. Prevalence of the psychiatric disorders in a population of children reached of mitochondrial disease [ Time Frame: Day 1 ]

    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)




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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child with mitochondrial cytopathy (defined by the presence of a mutation known to cause mitochondrial cytopathy or mitochondrial respiratory chain abnormality)
  • Aged 6 to 17 years
  • Beneficiary of a Social Security regime
  • Parents sign consent

Exclusion Criteria:

  • Child refusal to participate in the study
  • Complete inability to complete questionnaires (e.g. non-communicating child)
  • Child already included in intervention research modifying care

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832218


Contacts
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Contact: Elise RIQUIN, MD, PhD 02 41 35 44 42 ext +33 elise.riquin@chu-angers.fr
Contact: Béatrice GABLE 02 41 35 79 47 ext +33 begable@chu-angers.fr

Locations
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France
Dr RIQUIN Elise Recruiting
Angers, France
Contact: Elise RIQUIN       elise.riquin@chu-angers.fr   
Sponsors and Collaborators
University Hospital, Angers

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT03832218     History of Changes
Other Study ID Numbers: 49RC19_0004
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mitochondrial Diseases
Metabolic Diseases