Multicenter, randomized, open-label study of OROS methylphenidate versus atomoxetine: treatment outcomes in African-American children with ADHD

J Natl Med Assoc. 2005 Oct;97(10 Suppl):11S-16S.


The Formal Observation of Concerta versUs Strattera (FOCUS) study was conducted to assess, in children with ADHD, treatment outcomes with Concerta [OROS methylphenidate (MPH)], a once-daily controlled-release medication, and Strattera, (atomoxetine), a selective noradrenaline reuptake inhibitor, Because of the lack of data in minority groups treated for ADHD, the present subgroup analysis was conducted to determine the effectiveness and tolerability of ADHD treatments in African-American patients who were randomized to OROS MPH (n=125) or atomoxetine (n=58) during the FOCUS study. At the end of the study, the mean dose of OROS MPH was 32.8 +/- 10.9 mg and that of atomoxetine was 1.1 +/- 0.4 mg/kg. The results demonstrated that both treatments were associated with significant improvements in ADHD symptoms from baseline; however, patients who received OROS MPH demonstrated significantly greater improvements in total ADHD symptoms, inattentiveness and global improvement. The incidence of adverse events was similar in both treatment groups. OROS MPH and atomoxetine are effective and tolerable in the treatment of African Americans with ADHD, and significantly greater treatment responses were observed in patients receiving OROS MPH compared with those receiving atomoxetine over three weeks. Additional studies are needed to evaluate treatment response in this population.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Atomoxetine Hydrochloride
  • Attention Deficit Disorder with Hyperactivity / drug therapy*
  • Attention Deficit Disorder with Hyperactivity / ethnology
  • Central Nervous System Stimulants / administration & dosage
  • Central Nervous System Stimulants / therapeutic use*
  • Child
  • Delayed-Action Preparations
  • Female
  • Humans
  • Male
  • Methylphenidate / administration & dosage
  • Methylphenidate / therapeutic use*
  • Propylamines / therapeutic use*
  • Treatment Outcome


  • Central Nervous System Stimulants
  • Delayed-Action Preparations
  • Propylamines
  • Methylphenidate
  • Atomoxetine Hydrochloride