A Randomized, Open-Label Assessment of Response to Various Doses of Atomoxetine in Korean Pediatric Outpatients with Attention-Deficit/Hyperactivity Disorder
- Authors
- Cho, Soochurl; Lee, Soyoung Irene; Yoo, Hanik; Song, Dong Ho; Ahn, Dong-Hyun; Shin, Dong Won; Yum, Sun Young; Walton, Richard; Mendez, Luis
- Issue Date
- Jun-2011
- Publisher
- 대한신경정신의학회
- Keywords
- ADHD; Atomoxetine; Dose response; Korea; Pediatric
- Citation
- PSYCHIATRY INVESTIGATION, v.8, no.2, pp 141 - 148
- Pages
- 8
- Journal Title
- PSYCHIATRY INVESTIGATION
- Volume
- 8
- Number
- 2
- Start Page
- 141
- End Page
- 148
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/16496
- DOI
- 10.4306/pi.2011.8.2.141
- ISSN
- 1738-3684
1976-3026
- 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 >= 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 01153 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 >= 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. Psychiatry Investig 2011;8:141-148
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