An observational study in Attention Deficit Hyperactivity Disorder, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2015-03-18.
Sponsored by Chang Gung Memorial Hospital · Observational
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common child and adolescent psychiatric disorders. In recent years, some researchers have become interested in analyzing neuroendocrine substrate levels in ADHD, including dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEA-S), cortisol and testosterone. Previous work in ADHD has established a strong heritable component to the phenotype. The STS gene, SULT2A1 gene and TH gene are associated with the function of DHEA/DHEA-S, and the NR3C1 gene is associated with the regulation of cortisol. Therefore, the relationship between these genes and the etiology of ADHD warrants investigation. Moreover, compared to the phenotype, the endophenotypes of ADHD may be more capable of detecting the underlying neurobiological and hereditary mechanisms. Therefore, this study aims to investigate the relationships between neuroendocrine substrates (DHEA, DHEA-S, cortisol and testosterone), candidate genes (STS gene, SULT2A1 gene, TH gene and NR3C1 gene) and the phenotype and endophenotypes (disease subtypes, neurocognitive function and response to treatment) of ADHD.
To complete this work, we will recruit 300 patients with ADHD (probands) and 600 biological parents of the probands. DNA will be extracted from buccal cells by cheek swab. At baseline, saliva samples of ADHD patients will be collected between 7:00 and 8:00 am using the passive drool method, to analyze the levels of neuroendocrine substrates. The patients will undergo assessment for their clinical symptoms and neurocognitive function. Methylphenidate will then be administered to the patients and the usual practice followed. At week 4 and week 52, procedures similar to those performed at baseline will be repeated.
The results of this study may further elucidate the complexity of the pathophysiology of ADHD. We may determine whether the neuroendocrine system, which contains levels of neuroendocrine substrates and associated genes, plays a crucial role in the phenotype and endophenotypes of ADHD. The information may serve as an important reference for the direction of future study and clinical treatment for patients with ADHD.
At week 52, we will assess the long-term efficacy of the cases the symptoms and cognitive function in the first 52 weeks. We will collect the saliva sampe of ADHD patients at 7:00-8:00 in the morning. The behavioral and neurocognitive assessment will be performed using CGI-S、SNAP-IV(parent form), SNAP-IV(teacher form), CBCL, TRF, CPT and WISC-IV.
Finally, in K-SADS-E interviews to assess whether the patient is still meet the ADHD diagnostic criteria of DSM-IV-TR.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's planned enrollment of 300 is above the median of 134 across 122 observational studies indexed under Hyperkinesis.
Browse Hyperkinesis studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 234 are open to participants now.
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Patients from Kaohsiung, Taiwan by specialist clinical diagnosis of ADHD.
Exclusion Criteria:
Patients used Retina or Concerta twice a day lasting for one year.
Also known as: Retalin, concerta
The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)
Time frame: 15 min
This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital