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Thyroid Profile in Attention Deficit With Hyperactivity Disorder (ADHD) (THYRADHD)

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ClinicalTrials.gov Identifier: NCT05080491
Recruitment Status : Not yet recruiting
First Posted : October 15, 2021
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
Fondation Lenval

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.


Condition or disease Intervention/treatment Phase
Attention Deficit With Hyperactivity Disorder Diagnostic Test: immuno analysis and neuropsychological tests Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Abnormal Thyroid Profile in Children With Attention Deficit With Hyperactivity Disorder (ADHD)
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Arm Intervention/treatment
Experimental: Determination of thyroid profile and neuropsychological assessment Diagnostic Test: immuno analysis and neuropsychological tests

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).





Primary Outcome Measures :
  1. Definition of an abnormal thyroid profile [ Time Frame: at inclusion ]
    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.


Secondary Outcome Measures :
  1. Describe the subgroup and compare it to pattern of comorbidities :ADHD Rating Scale [ Time Frame: at inclusion ]

    measure of number of criteria for inattention, hyperactivity-impulsivity and therefore clinical presentation of ADHD (Predominant Inattentive, Predominant Hyperactive-Impulsive, Combined)

    ADHD Rating Scale: 9 inattention items and 9 hyperactivity-impulsivity items rated on a 0-3 scale (range 0-27), therefore the total score is on a 0-54 range. The higher the scores the higher the inattention and hyperactivity-impulsivity


  2. Describe the subgroup and compare it to pattern of comorbidities :Kiddie-SADDS-PL [ Time Frame: at inclusion ]

    measure of pattern of comorbidities diagnosed with Kiddie-SADDS-PL, manual, ocular and pedestrian preference, presence of atopic disease

    Kiddie-SADDS-PL: to make diagnoses according to DSM-V


  3. Describe the subgroup and compare it to pattern of comorbidities: Performance at the Attention Network Task [ Time Frame: at inclusion ]

    Determination of performance at the Attention Network Task (ANT) coupled with eye-tracking

    Three attention network will be assessed:

    Alerting: (RT without cue) minus (RT double cue) Orienting: (RT central cue) minus (RT orienting cue) Conflict: (RT flanker incongruent) minus (RT flanker congruent)

    Eye-tracking associated with ANT: On screen Areas Of Interest (AOI) are determined and for each of them the relative duration of gazing with be computed to build a patient-specific Task AOI : the fixation cross, cues and the target Peripheral AOI : the rest of the screen External AOI : outside the screen


  4. Describe the subgroup and compare it to pattern of comorbidities: Performance at Tower of London [ Time Frame: at inclusion ]

    Determination of performance at the test of the Tower of London coupled with eye-tracking.

    Tower of London: analysed variables are:

    Number of problems solved (maximum duration is one minute) Failure if three successive problems are unsolved Types of error : systematic rule violation, back-and-forth Percentage of problems solved with the execution (minimal) number of moves. Duration for planification and execution


  5. Calculate the classification concordance all pairs of dosage methods [ Time Frame: at inclusion ]
    Calculate the classification concordance (abnormal profile / normal profile) between all pairs of dosage methods (chromatography and 4 immuno-analysis based techniques)

  6. Calculate 95% reference intervals with age as co-variable and separately for boys and girls. [ Time Frame: at inclusion ]
    The age-dependent dosing curves with the reference interval for free-T3, free-T4 and TSH will be obtained by the method described by Royston et al. (1998) and Wright & Royston (1999).

  7. Dose thyroid hormones and TSH levels with 4 different techniques of immuno-analysis [ Time Frame: at inclusion ]
    Free-T3 and free-T4 dosed on different immuno-analyses techniques will be correlated



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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05080491


Contacts
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Contact: Hervé CACI,, MD PhD 4 92 03 03 92 ext +33 caci.h@pediatrie-chulenval-nice.fr
Contact: Dominique Donzeau, PhD donzeau.d@chu-nice.fr

Locations
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France
Hôpitaux Pédiatriques de Nice CHU-Lenval
Nice, France, 06200
Contact: Hervé CACI,, MD PhD    0492030392    caci.h@pediatrie-chulenval-nice.fr   
Contact: Dominique Donzeau, PhD       donzeau.d@chu-nice.fr   
Principal Investigator: Hervé CACI, MD PhD         
Sponsors and Collaborators
Fondation Lenval
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Responsible Party: Fondation Lenval
ClinicalTrials.gov Identifier: NCT05080491    
Other Study ID Numbers: 21-HPNCL-04
First Posted: October 15, 2021    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Lenval:
ADHD
thyroid
free-T3
triiodothyronine
free-T4
thyroxine
TSH
chromatography
immuno-analysis
child
adolescent
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases