Neuroendocrine Substrates, Candidate Genes and Endophenotypes in ADHD

NCT02392169 | Unknown DMC

• 1 other identifier: 101-4835A3
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

neuroendocrine; ADHD; heredity; cognitive function

Outcome Measures

Primary Outcomes (1)

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

  15 min

Interventions

Methylphenidate DRUG

Patients used Retina or Concerta twice a day lasting for one year.

Also known as: Retalin, concerta

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients from Kaohsiung, Taiwan by specialist clinical diagnosis of ADHD.

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 .

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Liang-Jen Wang

Kaohsiung City, Kaohsiung, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

oral mucosal cells

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Liang-Jen Wang, MD, MPH

  Chang Gung Memorial Hospital, Kaohsiung, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pao-Yen Lin, MD, PhD

CONTACT

886-7-7317123; py1029@adm.cgmh.org.tw

Study Design

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

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 18, 2015
• Study Start: August 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

TW (1)