title: An Open-Label, Randomized Trial of Methylphenidate and Atomoxetine Treatment in Children with Attention-Deficit/Hyperactivity Disorder.
abstract: OBJECTIVE
  The efficacy of both methylphenidate and atomoxetine has been established in placebo-controlled trials. The present study aimed to directly compare the efficacy of methylphenidate and atomoxetine in improving symptoms among children with attention-deficit/hyperactivity disorder (ADHD).
  
  
  METHODS
  The study sample included 160 drug-naïve children and adolescents 7-16 years of age, with DSM-IV-defined ADHD, randomly assigned to osmotic-release oral system methylphenidate (OROS-methylphenidate) (n=80) and atomoxetine (n=80) in a 24 week, open-label, head-to-head clinical trial. The primary efficacy measure was the score of the ADHD Rating Scale-IV Parents Version: Investigator Administered and Scored (ADHD-RS-IV). The secondary efficacy measures included the Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) and Chinese Swanson, Nolan, and Pelham IV scale (SNAP-IV), based on the ratings of investigators, parents, teachers, and subjects.
  
  
  RESULTS
  At week 24, mean changes in ADHD-RS-IV Inattention scores were 13.58 points (Cohen's d, -3.08) for OROS-methylphenidate and 12.65 points (Cohen's d, -3.05) for atomoxetine; and mean changes in ADHD-RS-IV Hyperactivity-Impulsivity scores were 10.16 points (Cohen's d, -1.75) for OROS-methylphenidate and 10.68 points (Cohen's d, -1.87) for atomoxetine. In terms of parent-, teacher-, and self-ratings on behavioral symptoms, both of the two treatment groups significantly decreased on the SNAP-IV scores at the end-point, with effect sizes ranging from 0.9 to 0.96 on the Inattention subscale and from 0.61 to 0.8 on the Hyperactivity/Impulsivity subscale for OROS-methylphenidate; and from 0.51 to 0.88 on the Inattention subscale and from 0.29 to 0.57 on the Hyperactivity/Impulsivity subscale for atomoxetine. No statistically significant differences between treatment groups were observed on the outcome measures. Vomiting, somnolence, and dizziness were reported more often for atomoxetine than for OROS-methylphenidate, whereas insomnia was reported more often for OROS-methylphenidate than for atomoxetine.
  
  
  CONCLUSIONS
  After 24 weeks of treatment, OROS-methylphenidate and atomoxetine had comparable efficacy in reducing core ADHD symptoms in drug-naïve children and adolescents with ADHD.
authors.affiliation: 1 Department of Psychiatry, National Taiwan University Hospital , Taipei, Taiwan .|2 Department of Psychiatry, College of Medicine, National Taiwan University , Taipei, Taiwan .
authors.forename: Chi-Yung
authors.initials: CY
authors.lastname: Shang
authors.affiliation: 1 Department of Psychiatry, National Taiwan University Hospital , Taipei, Taiwan .|3 Bali Psychiatric Center , Ministry of Health and Welfare, New Taipei City, Taiwan .
authors.forename: Yi-Lei
authors.initials: YL
authors.lastname: Pan
authors.affiliation: 1 Department of Psychiatry, National Taiwan University Hospital , Taipei, Taiwan .|2 Department of Psychiatry, College of Medicine, National Taiwan University , Taipei, Taiwan .
authors.forename: Hsiang-Yuan
authors.initials: HY
authors.lastname: Lin
authors.affiliation: 1 Department of Psychiatry, National Taiwan University Hospital , Taipei, Taiwan .
authors.forename: Lin-Wan
authors.initials: LW
authors.lastname: Huang
authors.affiliation: 1 Department of Psychiatry, National Taiwan University Hospital , Taipei, Taiwan .|2 Department of Psychiatry, College of Medicine, National Taiwan University , Taipei, Taiwan .|4 Graduate Institute of Brain and Mind Sciences and Clinical Medicine, College of Medicine, National Taiwan University , Taipei, Taiwan .
authors.forename: Susan Shur-Fen
authors.initials: SS
authors.lastname: Gau
mesh_terms: D000293:Adolescent; D000069445:Atomoxetine Hydrochloride / Q000627:therapeutic use*; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D002648:Child; D005260:Female; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008774:Methylphenidate / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome
chemical_list: D000697:Central Nervous System Stimulants; D008774:Methylphenidate; D000069445:Atomoxetine Hydrochloride