Titrating Optimal Dose of Osmotic-Controlled Release Oral Delivery (OROS)-Methylphenidate and Its Efficacy and Safety in Korean Children with ADHD: A Multisite Open Labeled Study
- Authors
- Song, Dong-Ho; Choi, Soul; Joung, Yoo Sook; Ha, Eun Hye; Kim, Boong-Nyun; Shin, Yee-Jin; Shin, Dongwon; Yoo, Hee Jeong; Cheon, Keun-Ah
- Issue Date
- Sep-2012
- Publisher
- KOREAN NEUROPSYCHIATRIC ASSOC
- Keywords
- ADHD; OROS-MPH; Optimal dose
- Citation
- PSYCHIATRY INVESTIGATION, v.9, no.3, pp 257 - 262
- Pages
- 6
- Journal Title
- PSYCHIATRY INVESTIGATION
- Volume
- 9
- Number
- 3
- Start Page
- 257
- End Page
- 262
- URI
- https://scholarworks.sookmyung.ac.kr/handle/2020.sw.sookmyung/6635
- DOI
- 10.4306/pi.2012.9.3.257
- ISSN
- 1738-3684
1976-3026
- Abstract
- Objective This study was aimed to determine effectiveness and tolerability of Osmotic-controlled Release Oral delivery (OROS) methylphenidate (MPH) and its optimal dose administered openly over a period of up to 12 weeks in drug naive Korean children with ADHD. Methods Subjects (n=143), ages 6 to 18-years, with a clinical diagnosis of any subtype of ADHD were recruited from 7 medical centers in Korea. An individualized dose of OROS-MPH was determined for each subject depending on the response criteria. The subjects were assessed with several symptom rating scales in week 1, 3, 6, 9 and 12. Results 77 of 116 subjects (66.4%) achieved the criteria for response and the average of optimal daily dose for response was to 30.05 +/- 12.52 mg per day (0.90 +/- 0.31 mg/kg/d) at the end of the study. Optimal dose was not significantly different between ADHD sub-types, whereas, significant higher dose was needed in older aged groups than younger groups. The average of optimal daily dose for response for the subjects aged above 12 years old was 46.38 +/- 15.52 per day (0.81 +/- 0.28 mg/kg/d) compared to younger groups (p<0.01). No serious adverse effects were reported and the dose did not have a significant effect on adverse effects. Conclusion Optimal mean dose of OROS-MPH was significantly different by age groups. Higher dose was needed in older aged groups than younger groups. Effectiveness and tolerability of OROS-MPH in symptoms of ADHD is sustained for up to 12 weeks. Psychiatry Investig 2012;9:257-262
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