Efficacy of Atomoxetine in the Neuropsychological Tests Among Children With ADHD
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The purpose of this study is examine the efficacy of atomoxetine on executive functioning
      measures including the Continuous Performance Test (CPT) and the executive function measures
      of the Cambridge Automated Neuropsychological Test Automated Battery (CANTAB).
    

Detailed description: 
      The rationale of this proposal is based upon the high prevalence (7.5% in Taiwan (Gau et al.,
      2004b)), the magnitude of the short- and long-term impact on individuals, family, and
      society, the responsibility of attention-deficit hyperactivity disorder ADHD to treatments
      with CNS stimulants and Atomoxetine. Although numerous studies have shown that
      methylphenidate demonstrates significant effect on improving neuropsychological functioning
      including inhibition of executive function (e.g., Aron et al., 2003; Kempton et al., 1999;
      Konrad et al., 2004) and motor control measures (e.g., Moll et al., 2000), there has been no
      study examining the effect of Atomoxetine on the improvement of response inhibition or other
      neuropsychological functioning among children with ADHD. As several clinical trials have
      shown the efficacy of Atomoxetine in improving the core symptoms of ADHD (e.g., Eiland and
      Guest, 2004; Michelson et al., 2002) and Atomoxetine has been approved by FDA as first line
      medication for child and adult ADHD in 2002, we anticipate that Atomoxetine will demonstrate
      significant efficacy on treating ADHD by improvement of neuropsychological measures.

      The objectives of this study are:

        1. To examine the efficacy of atomoxetine on executive functioning measures including the
           Continuous Performance Test (CPT) and the executive function measures of the Cambridge
           Automated Neuropsychological Test Automated Battery (CANTAB).

        2. To examine the efficacy of atomoxetine on other neuropsychological measures including
           the Wisconsin Card Sorting Test (WCST), and the attention, memory, and paired learning
           tests of the CANTAB.

        3. To validate the ADHD using psychopathological, neuropsychological, functional brain
           imaging, behavioral, and social correlates.

      This study is an open label, non randomized, clinical trial with daily dose of atomoxetine
      1.2 mg/kg for subjects with ADHD. Thirty drug-naïve children with DSM-IV ADHD and 30 normal
      children matched in sex, age, and IQ will be recruited. All of the participants will be
      assessed by the CPT, WSCT, CANTAB, and several measures covering domains of ADHD symptoms and
      social functioning. Subjects with ADHD will be reassessed using the neuropsychological tests
      and other measures on Week 4 (Visit 2) 3 days, Week 12 (Visit 2) 3 days of treatment with
      atomoxetine 1.2 mg/kg.

      The sample will consist of 30 subjects with ADHD, aged 10 to 15, and 30 subjects without
      ADHD, who are matched in age, sex, and IQ as cases. We anticipate that this study will
      provide enough evidence to support the efficacy of Atomoxetine not only on the symptoms
      improvement but also neuropsychological measures and fMRI studies among children with ADHD.
    

Observational model: Case-Only
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Subjects are diagnosed as DSM-IV, Attention Deficit Hyperactivity Disorder (ADHD).
      
Keywords: Attention-deficit/Hyperactivity Disorder; neuropsychological functioning; Atomoxetine