Identification of Biomarkers of Attention Deficit Disorder With or Without Hyperactivity (ADHD) by a Metabolomic Approach in Children

NCT03436017 | Completed

• 1 other identifier: RIPH3-RNI17/METHADA
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

Attention-deficit with or without hyperactivity disorder (ADHD) is a real health public concern. No easy-use diagnosis tool are available. Metabolomic approaches has brought very usefull data in others neurological diseases like amyotrophic lateral sclerosis or autism spectrum disorder, as we had shown in previous studies. Targeting on neurotransmitter pathways involving in ADHD, metabolomic screening could help to enhance our diagnosis power to better help numerus of children. We propose to study the phenylalanine and the tyrosine pathways with a multimodal metabolomic approach, in easy-available biological fluid (blood and urine), in child or adolescent suspected of ADHD. Our objectives are: 1- to determine a specific metabolomic signature of ADHD 2- to compare the diagnostic value of this metabolomic signature with the reference methodology for ADHD diagnosis, as now practiced in our reference center for learning troubles.

Conditions

Adhd

Keywords

adhd; metabolomics; child

Outcome Measures

Primary Outcomes (2)

• ADHD metabolomic's signature of blood

  Detection of metabolites (phenylalanine or catécholamines) in the blood of patients with ADHD at levels significantly different from baseline levels in the general population and rates found in patients with attention deficit and / or hyperactivity disorders but that multidisciplinary assessment excludes the diagnosis of ADHD.

  At baseline

• ADHD metabolomic's signature of urine

  Detection of metabolites (phenylalanine or catécholamines) in the urine of patients with ADHD at levels significantly different from baseline levels in the general population and rates found in patients with attention deficit and / or hyperactivity disorders but that multidisciplinary assessment excludes the diagnosis of ADHD.

  At baseline

Study Arms (2)

ADHD

Patient with ADHD diagnosis criterion. The aim is the identification of Biomarkers of ADHD by a Metabolomic Approach

Other: Metabolomic approach

non ADHD

Patient with symptom of hyperactivity and/or attention deficiency but without ADHD diagnosis criterion. The aim is the identification of Biomarkers of ADHD by a Metabolomic Approach.

Other: Metabolomic approach

Interventions

Metabolomic approach OTHER

Biological samples (blood and urine) for a multimodal metabolomic approach

ADHD; non ADHD

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Child or adolescent with symptoms of attention disorders and / or hyperactivity, aged from 6 to 15 years old, and consulting in current care in our university hospital

You may qualify if:

• Child or adolescent with symptoms of attention disorders and / or hyperactivity
• aged from 6 to 15 years old

You may not qualify if:

• Failure or refusal of all or part of the multidisciplinary evaluation (medical and / or neuropsychological assessments and / or biological assessments)
• Identification of an intercurrent condition likely to have an impact on metabolomic analyzes (acute infection, fever, etc.)
• Parents or legal guardians opposed to data processing

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

University Hospital TOURS

Tours, 37044, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples Urinary samples

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Pierre CASTELNAU, MD-PhD

  CHU Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: February 19, 2018
• Study Start: January 29, 2018
• Primary Completion: November 12, 2019
• Study Completion: November 12, 2019
• Last Updated: June 24, 2021

Record last verified: 2021-06

Locations

FR (1)