Psychiatry Investig.
2011 Jun;8(2):141-148.
A Randomized, Open-Label Assessment of Response to Various Doses of Atomoxetine in Korean Pediatric Outpatients with Attention-Deficit/Hyperactivity Disorder
- Affiliations
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- 1Department of Neuropsychiatry, Seoul National University Hospital, Seoul, Korea.
- 2Department of Psychiatry, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.
- 3Department of Psychiatry, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
- 4Department of Psychiatry, Yonsei University Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
- 5Department of Psychiatry, Hanyang University Medical Center, Seoul, Korea.
- 6Department of Psychiatry, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
- 7Neuroscience Clinical Research, Eli Lilly and Company, Seoul, Korea.
- 8Intercontinental Information Sciences, Eli Lilly Pty Ltd Sydney, NSW, Australia.
- 9Eli Lilly and Company, Barranca, Mexico. mendezl@lilly.com
Abstract
OBJECTIVE
This multicenter, randomized, open-label, parallel trial aimed to provide a detailed dose-response profile for atomoxetine in Korean pediatric outpatients with attention-deficit/hyperactivity disorder (ADHD).
METHODS
Male and female outpatients aged 6-18 years with ADHD meeting symptom severity criteria of 1.5 standard deviations above age and gender norms on the ADHD Rating Scale-IV-Parent: Investigator-Administered and Scored (ADHDRS-IV-Parent: Inv), and a Clinical Global Impression-ADHD-Severity score > or =4 were randomized to atomoxetine (mg/kg/day) 0.2 fixed, 0.5 fixed or 0.5 (7 days), 0.8 (7 days) then 1.2 for 28 days. The primary efficacy measure was change in ADHDRS-IV-Parent: Inv total score after 6 weeks of atomoxetine treatment.
RESULTS
Of 153 randomized patients, 83.7% were male and mean age was 9.8 (SD+/-2.4) years. The completion rate was 86.9%. A graded dose response was apparent with mean change in ADHDRS-IV-Parent: Inv total scores of -9.6, -12.3 and -14.5 with atomoxetine 0.2, 0.5 and 1.2 mg/kg/day, respectively (p=0.024 - F-test). Moreover, a greater reduction in ADHD symptoms, as assessed by mean change from baseline to endpoint CGI-S and mean CGI-ADHD-Improvement at endpoint, was also observed with increasing atomoxetine dose. More patients receiving atomoxetine 1.2 mg/kg/day reported > or =1 treatment-emergent adverse event/s (58.3%) compared with 0.5 (40.7%; p=0.11) or 0.2 mg/kg/day (29.4%; p=0.005). These were generally mild to moderate.
CONCLUSION
Atomoxetine was found to be safe and well tolerated at all doses administered in Korean pediatric ADHD patients, and 1.2 mg/kg/day was an efficacious dose in this population.
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