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

NCT03832218 | Completed

• 1 other identifier: 49RC19_0004
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitochondrial Diseases

Outcome Measures

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)

  Day 1

Study Arms (1)

Mitochondrial disease

OTHER

Psychiatric assessment

Diagnostic Test: Psychiatric assessment

Interventions

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)

Mitochondrial disease

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Dr RIQUIN Elise

Angers, France

Location

MeSH Terms

Conditions

Mitochondrial Diseases

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 6, 2019
• Study Start: May 2, 2019
• Primary Completion: February 27, 2020
• Study Completion: February 27, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-04

Locations

FR (1)