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CompletedNCT03832218MITOPSYUpdated Nov 10, 2020

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

An interventional study of Psychiatric assessment in Mitochondrial Diseases, sponsored by University Hospital, Angers. Completed at 1 site in France. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2020-11-10.

Sponsored by University Hospital, Angers · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
6 Years to 17 Years
Sex
All
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Study 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.

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Conditions studied

  • Mitochondrial Diseases
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In context

Mitochondrial Diseases

182 studies on the registry are indexed under Mitochondrial Diseases; 54 are open to participants now.

This study's enrollment of 12 is below the median of 30 across 100 interventional studies indexed under Mitochondrial Diseases.

Browse Mitochondrial Diseases studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Other
    Mitochondrial disease

    Psychiatric assessment

    Diagnostic Test: Psychiatric assessment

Interventions

  • Diagnostic testPsychiatric 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)

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What researchers measure

Primary outcomes

  1. Prevalence of the psychiatric disorders in a population of children reached of mitochondrial disease

    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)

    Time frame: Day 1

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Study locations

1 site
  • Dr RIQUIN Elise
    Angers, France
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03832218
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Feb 6, 2019
Start date
May 2, 2019
Primary completion
Feb 27, 2020
Completion
Feb 27, 2020
Last update
Nov 10, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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