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

NCT ID: NCT03832218

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-02

Study Completion Date

2020-02-27

Brief Summary

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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.

Detailed Description

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Conditions

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Mitochondrial Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Mitochondrial disease

Psychiatric assessment

Group Type OTHER

Psychiatric assessment

Intervention Type 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)

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dr RIQUIN Elise

Angers, , France

Site Status

Countries

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France

Other Identifiers

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49RC19_0004

Identifier Type: -

Identifier Source: org_study_id