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临床试验/NCT02074176
NCT02074176Unknown不适用

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

National Taiwan University Hospital0 个研究点目标入组 50 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
SNAP-IV

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

SNAP-IV

时间窗: baseline

self-administered questionnaires to measures ADHD symptoms

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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