Background： Attention-deficit hyperactivity disorder （ADHD） is the most common mental and behavioral disorder in school-aged children. This study evaluated the effect of osmotic-release oral system （OROS） methylp...Background： Attention-deficit hyperactivity disorder （ADHD） is the most common mental and behavioral disorder in school-aged children. This study evaluated the effect of osmotic-release oral system （OROS） methylphenidate （MPH） on cognitive function and academic performance of Chinese school-aged children with ADHD. Methods： This 12-week, prospective, multicenter, open-label, self-controlled study enrolled 153 Chinese school-aged children with ADHD and 41 non-ADHD children. Children with ADHD were treated with once-daily OROS-MPH （18 mg, 36 mg, or 54 mg）. The primary endpoints were Inattention/Overactivity （I/O） with Aggression Conners Behavior Rating Scale （IOWA） and Digit Span Test at week 12 compared with baseline. Secondary endpoints included opposition/defiant （O/D） subscale of IOWA, Clinical Global Impression （CGI）, Coding Test, Stroop Color-word Test, Wisconsin Card Sorting Test （WCST）, academic performance on teacher-rated school examinations, and safety at week 12 compared with baseline. Both non-ADHD and ADHD children received the same frequency of cognitive operational test to avoid the possible bias caused by training. Results： A total of 128 patients were evaluated with cognitive assessments. The OROS-MPH treatment significantly improved IOWA Conners I/O subscale scores at week 12 （3.8 ± 2.3） versus baseline （10.0 ± 2.4; P 〈 0.0001）. Digit Span Test scores improved significantly （P 〈 0.0001 ） with a high remission rate （81.1%） at week 12 versus baseline. A significant （P 〈 0.0001 ） improvement was observed in O/D subscale of IOWA, CGI, Coding Test, Stroop Color-word Test, WCST, and academic performance at week 12 versus baseline. Very few practice-related improvements were noticed in the non-ADHD group at week 12 compared with baseline. No serious adverse events and deaths were reported during the study. Conclusions： The OROS-MPH treatment effectively controlled symptoms of ADHD and significantly improved academic performance and cognitive fimction of Chinese school-aged children with ADHD. The treatment was found to be sate and generally well-tolerated over 12 weeks.展开更多
文摘Background： Attention-deficit hyperactivity disorder （ADHD） is the most common mental and behavioral disorder in school-aged children. This study evaluated the effect of osmotic-release oral system （OROS） methylphenidate （MPH） on cognitive function and academic performance of Chinese school-aged children with ADHD. Methods： This 12-week, prospective, multicenter, open-label, self-controlled study enrolled 153 Chinese school-aged children with ADHD and 41 non-ADHD children. Children with ADHD were treated with once-daily OROS-MPH （18 mg, 36 mg, or 54 mg）. The primary endpoints were Inattention/Overactivity （I/O） with Aggression Conners Behavior Rating Scale （IOWA） and Digit Span Test at week 12 compared with baseline. Secondary endpoints included opposition/defiant （O/D） subscale of IOWA, Clinical Global Impression （CGI）, Coding Test, Stroop Color-word Test, Wisconsin Card Sorting Test （WCST）, academic performance on teacher-rated school examinations, and safety at week 12 compared with baseline. Both non-ADHD and ADHD children received the same frequency of cognitive operational test to avoid the possible bias caused by training. Results： A total of 128 patients were evaluated with cognitive assessments. The OROS-MPH treatment significantly improved IOWA Conners I/O subscale scores at week 12 （3.8 ± 2.3） versus baseline （10.0 ± 2.4; P 〈 0.0001）. Digit Span Test scores improved significantly （P 〈 0.0001 ） with a high remission rate （81.1%） at week 12 versus baseline. A significant （P 〈 0.0001 ） improvement was observed in O/D subscale of IOWA, CGI, Coding Test, Stroop Color-word Test, WCST, and academic performance at week 12 versus baseline. Very few practice-related improvements were noticed in the non-ADHD group at week 12 compared with baseline. No serious adverse events and deaths were reported during the study. Conclusions： The OROS-MPH treatment effectively controlled symptoms of ADHD and significantly improved academic performance and cognitive fimction of Chinese school-aged children with ADHD. The treatment was found to be sate and generally well-tolerated over 12 weeks.
