The Effectiveness of Atomoxetine on Brain Imaging, Neuropsychological, and Social Functions in Adults ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      Attention deficit/hyperactivity disorder (ADHD) has been recognized as a common (5-8%),
      early-onset, long-term impairing, heterogeneous neuropsychiatric disorder with high
      heritability. Pharmacotherapy (methylphenidate and atomoxetine) has been proved to be the
      most effective treatment for ADHD. Gau (PI) has done extensive research on ADHD and published
      7 SCI papers in ADHD pharmacotherapy. The PI published the first paper in the effectiveness
      of atomoxetine in improving executive functions among 30 boys with ADHD in the world
      (International Journal of Neuropsychopharmacology, 2009 Oct 23:1-14. [Epub]). Due to its
      lifelong impairments up to adulthood, adult ADHD has drawn much more attention in Western
      studies in the past decade; however, there is lack of such information in Asian population
      except the PI's three SCI papers on adult ADHD. Because little is known about atomoxetine
      effect in adults with ADHD except symptoms reduction, this proposal aims to investigate the
      efficacy of atomoxetine beyond symptoms improvement. The significance of this project is its
      novelty and research and clinical relevance because there is lack of information regarding
      long-term effect of atomoxetine on neuropsychological and brain imaging functions on adults
      with ADHD, a high-prevalent mental disorder with long-term impairment in adults.
    

Detailed description: 
      Specific Aims:

        1. To examine the efficacy of atomoxetine in improving neuropsychological functioning
           (CANTAB, Time Perception Tasks) and structural (DSI) and functional (resting fMRI) brain
           connectivity as the primary efficacy endpoints.

        2. To examine the efficacy of atomoxetine in reducing ADHD core symptoms and in improving
           family/social/academic/occupational adjustment and quality of life.

      The study design is a randomized open-label, methylphenidate control trial. The sample
      consists of 60 adults, aged 18-50, with clinical diagnosis of DSM-IV. All participants will
      be randomly assigned to atomoxetine (n= 30), methylphenidate (n= 15), and clinical visit with
      psychological counseling (n=15) in a 8-week randomized clinical trial with 3 treatment arms.

      The measures included psychiatric interviews (ADHD+SADS), the CGI-ADHD-S, the standardized
      self-reported questionnaires (the AAQoL, WFIRS-S, and WFIRS-P for social function; ASRS for
      ADHD symptoms), neuropsychological tests (CANTAB including attention tasks, visual memory,
      executive functioning, and gambling test; Time Perception Task), and brain imaging (DSI and
      resting fMRI).

      They will be reassessed with safety, ADHD symptoms and social functioning/quality of life at
      baseline, week 2 (± 5 days), week 4 (± 5 days), and week 8 (± 5 days); neuropsychological
      tests at baseline, week 4 (± 5 days), and week 8 (± 5 days); and brain imaging studies (DSI
      and resting-fMRI) at baseline and week 8 (± 5 days). Additionally, blood sample will be
      collected at baseline for future pharmacogenomic study.

      We anticipate that this study will be one of the first to investigate the efficacy of
      atomoxetine on neuropsychological functioning, and structural and functional brain
      connectivity in the world. If this research can be carried out, it will be the first project
      using brain images as assessment tools in a clinical trial among psychiatric patients in
      psychiatric field in Taiwan.
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        We will recruit 60 adults, aged 18 to 50, who are diagnosed with ADHD at the PI Gau's Adult
        ADHD clinic at the Department of Psychiatry, National Taiwan University Hospital.
      
Keywords: adults with attention-deficit hyperactivity disorder; atomoxetine; neuropsychological functioning; brain imaging studies