Skip to main content
OpenTrials
Completed

NCT Number: NCT03832218

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr RIQUIN Elise

Angers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychiatric assessment

Diagnostic Test

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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: MITOPSY

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2019
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.