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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

Title
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
Dong-Ho Song;Soul Choi;Keun-Ah Cheon;Hee Jeong Yoo;Dongwon Shin;Yee-Jin Shin;Boong-Nyun Kim;Eun Hye Ha;Yoo Sook Joung
Issue Date
2012
Journal Title
Psychiatry Investigation
ISSN
1738-3684
Citation
Psychiatry Investigation, Vol.9(3) : 257~262, 2012
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 naïve 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 subtypes, 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.
URI

http://ir.ymlib.yonsei.ac.kr/handle/22282913/91757
DOI
10.4306/pi.2012.9.3.257
Appears in Collections:
1. 연구논문 > 1. College of Medicine > Dept. of Psychiatry
Yonsei Authors
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