Endocrine Disrupting Chemicals and Hormones in ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

— ADHD  

Official title:

The Roles of Endocrine Disrupting Chemicals, Growth Hormone and Thyroid Function in Attention-deficit/Hyperactivity Disorder

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04970303
• Other study ID #: 201900376A3
• Status: Enrolling by invitation
• Start date: July 12, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2021
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Therefore, this study aims (1) to investigate the prospective role of EDCs, growth hormone and thyroid function in clinical manifestations of ADHD; and (2) to determine the influence of pharmacotherapy on growth hormone and thyroid function among patients with ADHD under a one-year methylphenidate treatment.

Methods: In this two-year study, we will recruit 120 patients with ADHD (aged between 6 and 16) and 120 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. 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.

This study will provide proof of the relationships of EDCs, endocrine systems and ADHD manifestations in clinical samples and further explain the biological pathogenesis of ADHD. In addition, this study will elucidate the influence of ADHD medications on growth hormone and thyroid function. Such information may become an important reference for future research and safety of pharmacotherapy for patients with ADHD.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 240
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Methylphenidate
Retina or Concerta

Locations

Country	Name	City	State
Taiwan	Liang-Jen Wang	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ADHD clinical symptoms, The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)	The SNAP-IV is a 26-item questionnaire used to evaluate ADHD symptoms and severity that needs to be completed by parents or teachers. The 26 items include 18 for ADHD symptoms (nine for inattention and nine for hyperactivity/impulsivity) and eight for oppositional defiant disorder (ODD) symptoms as defined by the DSM-IV. Each item is scored from 0-3 on a Likert scale. The total scores are ranged between 0 (min) to 78 (max), and higher scores mean a greater severity of ADHD.	Baseline
Other	ADHD clinical symptoms, The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)	The SNAP-IV is a 26-item questionnaire used to evaluate ADHD symptoms and severity that needs to be completed by parents or teachers. The 26 items include 18 for ADHD symptoms (nine for inattention and nine for hyperactivity/impulsivity) and eight for oppositional defiant disorder (ODD) symptoms as defined by the DSM-IV. Each item is scored from 0-3 on a Likert scale. The total scores are ranged between 0 (min) to 78 (max), and higher scores mean a greater severity of ADHD.	month 12
Primary	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
Primary	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	Children's growth-Height	Height (cm)	Baseline
Secondary	Children's growth-Height	Height (cm)	month 12
Secondary	Children's growth-body weight	body weight (kg)	Baseline
Secondary	Children's growth-body weight	body weight (kg)	month 12