Executive Function Disorders and Anxio-depressive Symptomatology in Children and Adolescents With Mitochondrial Pathologies (MITOPSY)
Primary Purpose
Mitochondrial Diseases
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Psychiatric assessment
Sponsored by
About this trial
This is an interventional diagnostic trial for Mitochondrial Diseases
Eligibility 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
Sites / Locations
- Dr RIQUIN Elise
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Mitochondrial disease
Arm Description
Psychiatric assessment
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03832218
First Posted
February 1, 2019
Last Updated
November 9, 2020
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT03832218
Brief Title
Executive Function Disorders and Anxio-depressive Symptomatology in Children and Adolescents With Mitochondrial Pathologies
Acronym
MITOPSY
Official Title
Executive Function Disorders and Anxio-depressive Symptomatology in Children and Adolescents With Mitochondrial Pathologies
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
February 27, 2020 (Actual)
Study Completion Date
February 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitochondrial Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mitochondrial disease
Arm Type
Other
Arm Description
Psychiatric assessment
Intervention Type
Diagnostic Test
Intervention Name(s)
Psychiatric assessment
Intervention Description
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 Measure Information:
Title
Prevalence of the psychiatric disorders in a population of children reached of mitochondrial disease
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Dr RIQUIN Elise
City
Angers
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Executive Function Disorders and Anxio-depressive Symptomatology in Children and Adolescents With Mitochondrial Pathologies
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