Thyroid Profile in Attention Deficit With Hyperactivity Disorder (ADHD)

NCT05080491 | Unknown

• 1 other identifier: 21-HPNCL-04
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: The observational data of University Children's Hospitals of Nice, suggest that about a quarter of children and adolescents with ADHD may present with an abnormal thyroid profile. Main objective: To confirm that a subsample of children and adolescents with ADHD present with an abnormal thyroid profile using the gold standard for free fraction of hormones : chromatography with mass spectrometry. Secondary objective: To examine to what extent this categorization holds using classic immuno-analytic assays. To characterize clinically and from a neuropsychological point of view this subsample and compare it to the other participants. Study duration and design: 30 months (24 months for inclusion and 6 months for data analyses) open-label, (category 2 : interventional research with minimal risks or constraints), multicentre, without treatment or placebo administration. Expected outcomes: Ancillary studies will investigate genetic physiopathological mechanisms (polymorphisms of deiodase or transmembrane carriers of thyroid hormones) and link this profile to other biological markers proposed in the literature (low ferritinemia, higher oxidative stress, atopic comorbid disease). The clinical trajectory of this subgroup and the persistence of this abnormal thyroid profile in adulthood will be a relevant issue in the future.

Conditions

Attention Deficit With Hyperactivity Disorder

Keywords

ADHD; thyroid; free-T3; triiodothyronine; free-T4; thyroxine; TSH; chromatography; immuno-analysis; child; adolescent

Outcome Measures

Primary Outcomes (1)

• Definition of an abnormal thyroid profile

  To confirm by chromatography with mass spectrometry the existence of a subgroup of children and adolescents with ADHD with this abnormal thyroid profile. Free T3 greater than the 97.5 percentile of the reference interval in chromatography, free T4 between the 2.5 percentile and the 97.5 percentile with this same technique, and free TSH between the 2.5 percentile and the 97.5 percentile of the immuno-analytical reference interval.

  at inclusion

Secondary Outcomes (7)

• Describe the subgroup and compare it to pattern of comorbidities :ADHD Rating Scale

  at inclusion

• Describe the subgroup and compare it to pattern of comorbidities :Kiddie-SADDS-PL

  at inclusion

• Describe the subgroup and compare it to pattern of comorbidities: Performance at the Attention Network Task

  at inclusion

• Describe the subgroup and compare it to pattern of comorbidities: Performance at Tower of London

  at inclusion

• Calculate the classification concordance all pairs of dosage methods

  at inclusion

Study Arms (1)

Determination of thyroid profile and neuropsychological assessment

EXPERIMENTAL

Diagnostic Test: immuno analysis and neuropsychological tests

Interventions

immuno analysis and neuropsychological tests DIAGNOSTIC_TEST

A venous blood sample will be taken for assay in immuno-analysis including and for assay in chromatography with mass spectrometry. Patients will participate in computer neuropsychological tests: . Venous blood collection and the administration : the tubes are transported to the biochemistry laboratory of the University Hospital Center of Nice (CHU Nice) which prepares five aliquots (4 for assays in immuno-analysis including 2 on site, and one for assay in chromatography with mass spectrometry. Administration of two neuropsychological tests on computer(Attention Network Task and Tower of London).

Determination of thyroid profile and neuropsychological assessment

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Boys or girls aged by 7 and 17 years old included
• Diagnosed with ADHD according to DSM-5 criteria with either Inattentive predominant, Hyperactive-impulsive predominant or Combined presentations.
• Scoring at least 28 (maximum value 54) on the ADHD-RS total score that is the sum of 18 items each rated on a 0-3 scale.
• Scoring at least 4 (= Moderate) on the Clinical Global Impression - Severity scale
• Without any clinical symptom of either hypothyroidism or hyperthyroidism
• Who signed an informed consent form
• Whose at least of parents (or default a legal representative) signed an informed consent form

You may not qualify if:

• Known or concomitant diagnosis of Autism Spectrum Disorder according to DSM-5 criteria Known or concomitant diagnosis of Schizophrenia or Psychotic Disorder according to DSM-5 criteria Known or concomitant diagnosis of any thyroid disorder (hypothyroidism or hyperthyroidism) whatever the cause might be Known or concomitant diagnosis of any genetic condition affecting the thyroid function (e.g. Down syndrome)
• Intake in the last month of a psychotropic drug for:
• ADHD: methylphenidate, atomoxetine, dexamphetamine, lisdexamphetamine, guanfacine or clonidine.
• Any psychiatric disorder (antipsychotic, anxiolytics, antidepressant, etc.)
• Intake in the last month of a molecule affecting the thyroid function:
• Any compound containing thyroid hormones
• Anti-thyroid drugs: carbimazole, thiamazole, propylthiouracil and perchlorate
• Any compound containing iodine
• Significant application on the skin of iodized products in the last six months
• Injection of water-soluble iodine contrast agents in the last 2 months or fat-soluble in the last 6 months

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, 06200, France

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Thyroid Diseases

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Endocrine System Diseases

Central Study Contacts

Hervé CACI,, MD PhD

CONTACT

4 92 03 03 92; caci.h@pediatrie-chulenval-nice.fr

Dominique Donzeau, PhD

CONTACT

donzeau.d@chu-nice.fr

Study Design

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

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 15, 2021
• Study Start: November 21, 2023
• Primary Completion: January 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 28, 2024

Record last verified: 2023-03

Locations

FR (1)