NCT04970303

Brief Summary

Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder in children and adolescents. Growth hormone and thyroid function are associated with both physical and neurocognitive development. Endocrine disrupting chemicals (EDCs) could disturb the normal function of endocrine systems, and further link to the pathophysiology of ADHD. In addition, whether methylphenidate for treating ADHD influences growth hormone and thyroid function of patients remains unclear.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

2.5 years

First QC Date

July 1, 2021

Last Update Submit

July 11, 2021

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHDendocrine disrupting chemicalsgrowth hormonethyroidmethylphenidate

Outcome Measures

Primary Outcomes (2)

  • Growth hormone and thyroid function

    IGF-1 (ng/mL), insulin-like growth factor-1; IGFBP-3 (ng/mL), IGF binding protein-3; TSH (µIU/mL), thyroid-stimulating hormone; T3 (ng/dL), triiodothyronine; T4 (µg/dL), thyroxine

    Baseline

  • Growth hormone and thyroid function

    IGF-1 (ng/mL), insulin-like growth factor-1; IGFBP-3 (ng/mL), IGF binding protein-3; TSH (µIU/mL), thyroid-stimulating hormone; T3 (ng/dL), triiodothyronine; T4 (µg/dL), thyroxine

    month 12

Secondary Outcomes (4)

  • Children's growth-Height

    Baseline

  • Children's growth-Height

    month 12

  • Children's growth-body weight

    Baseline

  • Children's growth-body weight

    month 12

Other Outcomes (2)

  • ADHD clinical symptoms, The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)

    Baseline

  • ADHD clinical symptoms, The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)

    month 12

Study Arms (2)

Case group

investigator will recruit 60 patients with ADHD (aged between 6 and 16). Blood (10 ml) and urine (10 ml) will be obtained from each participant to analyze the levels of EDCs (Phthalates, Phenols and Parabens), growth hormone and thyroid function (TSH, T3, Free T4, T4, growth hormone, IGF-1and IGF-BP3). Behavior symptoms (ADHD-RS and SNAP-IV) and neuropsychological function (WISC, CPT and CATA) of each participant will be assessed. Patients with ADHD will receive treatment in a clinical practice and then will be followed up for 12 months. At the 12th month, the same procedures as those performed at the baseline will be replicated for patients with ADHD.

Drug: Methylphenidate

Control group

investigator will recruit 60 age- and gender-matched control subjects. Blood (10 ml) and urine (10 ml) will be obtained from each participant to analyze the levels of EDCs (Phthalates, Phenols and Parabens), growth hormone and thyroid function (TSH, T3, Free T4, T4, growth hormone, IGF-1and IGF-BP3). Behavior symptoms (ADHD-RS and SNAP-IV) and neuropsychological function (WISC, CPT and CATA) of each participant will be assessed.

Interventions

MethylphenidateDRUG

Retina or Concerta

Also known as: used Retina or Concerta
Case group

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

120 patients with ADHD (aged between 6 and 16) and 60 age- and gender-matched control subjects.

You may qualify if:

  • Patients with ADHD aged between 6 and 16.
  • The patients were either newly diagnosed with ADHD or had an existing diagnosis but had not taken medication for ADHD during the previous 6 months or more.

You may not qualify if:

  • Patients with a history of major physical or additional psychiatric diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liang-Jen Wang

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityThyroid Diseases

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Liang-Jen Wang, MD, MPH, PhD

    Chang Gung Memorial Hospital, Kaohsiung, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Visiting Staff

Study Record Dates

First Submitted

July 1, 2021

First Posted

July 21, 2021

Study Start

July 12, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

July 21, 2021

Record last verified: 2021-07

Locations

TW(1)