Plasma Orexin A and mRNA Expression Levels of Pre-pro-orexin Gene in Attention-Deficit Hyperactivity Disorder

NCT ID: NCT02074176

Last Updated: 2014-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Background: Attention deficit hyperactivity disorder (ADHD) is an early onset, highly heritable, clinically heterogeneous, long-term impairing disorder with tremendous impact on individuals, families, and societies. It affects 7.5% of school-aged children in Taiwan. Emerging evidence has suggested that patients with ADHD may present with a deficit of attention, alertness and sleep disturbances. Since attention, alertness, and sleep disturbances may significantly increase the functional impairment of ADHD, gaining insight into their pathophysiology as well as into their treatment is of relevance to provide a better clinical management of patients suffering from ADHD. The orexin system, located in the hypothalamus, takes an important role in homeostatic functions, such as attention, alertness, sleep-wake cycle, and feeding. To our best knowledge, the functioning of the orexin system has never been investigated in patients with ADHD. Given the involvement of the orexin system in the control of alertness and reward seeking, the present study aims to examine whether plasma orexin and mRNA expression levels of pre-pro-orexin gene are associated with the symptoms and neurocognitive deficits of ADHD.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Specific Aims:

1. To evaluate the correlations between plasma levels of orexin A and symptoms of ADHD.
2. To evaluate the correlations between mRNA expression levels of pre-pro-orexin gene and symptoms of ADHD.
3. To evaluate the correlations between plasma levels of orexin A and neurocognitive dysfunction of ADHD.
4. To evaluate the correlations between mRNA expression levels of pre-pro-orexin gene and neurocognitive dysfunction of ADHD.

Subjects and Methods: Subjects in this study will be recruited from Children's Mental Health Center, Department of Psychiatry, National Taiwan University Hospital (NTUH). The sample will consist of 50 ADHD probands (aged 6 to 18 years) and 50 age- and sex- matched healthy controls. The phenotype measures include (1) interviews for psychopathology (K-SADS-E) and social functioning (SAICA), (2) self-administered questionnaires to measures ADHD symptoms (SNAP-IV), comorbid conditions (YSR, CBCL), and family support (Family APGAR), and (3) Neuropsychological tests: CPT, WISC-III, and CANTAB. Plasma orexin A and mRNA expression levels of pre-pro-orexin gene will be measured in all participants.

Anticipated Results: We anticipate the identification of potential relationship between plasma orexin A, mRNA expression and symptoms of ADHD. In addition, this study will determine the association of plasma orexin A and mRNA expression with the neurocognitive deficits of ADHD. We hope that this study will elucidate the pathogenesis of ADHD, and orexin A will be a possible biomarker for this disorder. In addition, the data of orexin A and mRNA expression of pre-pro-orexin gene in ADHD will provide insight in developing more specific and more effective treatment for ADHD.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Attention-deficit/hyperactivity disorder orexin A mRNA

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* For the proband subjects to be eligible to participate in this study, they need to fit the following criteria: (1) subjects have a clinical diagnosis of ADHD, or Hyperkinetic Disorder defined by the DSM-IV and ICD-10, respectively, which was made by a full-time board-certificated child psychiatrist at the first visit and following visits; (2) their ages range from 6 to 18 when we conduct the study; (3) subjects have at least one biological parent; and (4) both parents are Han Chinese.

Exclusion Criteria

* The proband subjects will be excluded from the study if they currently meet criteria or have a history of the following condition as defined by DSM-IV: Schizophrenia, Schizoaffective Disorder, Organic Psychosis, or Pervasive Developmental Disorder. Moreover, the subjects will also be excluded from the study if they completely cannot cooperate with blood withdrawal.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chi-Yung Shang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201008049R

Identifier Type: -

Identifier Source: org_study_id