Endocrine Disrupting Chemicals and Hormones in ADHD
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
Retina or Concerta
Other Names:
|
| 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. |
Outcome Measures
Primary Outcome Measures
- Growth hormone and thyroid function [Baseline]
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
- Growth hormone and thyroid function [month 12]
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
Secondary Outcome Measures
- Children's growth-Height [Baseline]
Height (cm)
- Children's growth-Height [month 12]
Height (cm)
- Children's growth-body weight [Baseline]
body weight (kg)
- Children's growth-body weight [month 12]
body weight (kg)
Other Outcome Measures
- ADHD clinical symptoms, The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV) [Baseline]
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.
- ADHD clinical symptoms, The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV) [month 12]
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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Liang-Jen Wang | Kaohsiung | Taiwan |
Sponsors and Collaborators
- Chang Gung Memorial Hospital
Investigators
- Principal Investigator: Liang-Jen Wang, MD, MPH, PhD, Chang Gung Memorial Hospital, Kaohsiung, Taiwan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 201900376A3