title: An Open-label, Self-control, Prospective Study on Cognitive Function, Academic Performance, and Tolerability of Osmotic-release Oral System Methylphenidate in Children with Attention-deficit Hyperactivity Disorder.
abstract: 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 function of Chinese school-aged children with ADHD. The treatment was found to be safe and generally well-tolerated over 12 weeks.
  
  
  BACKGROUND
  ClinicalTrials.gov, NCT01933880; http://clinicaltrials.gov/ct2/show/NCT01933880?term=CONCERTAATT4099&rank=1.
authors.affiliation: Department of Pediatrics, Beijing Anding Hospital, Capital Medical University, Beijing 100088, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Zheng
authors.forename: Jian-Min
authors.initials: JM
authors.lastname: Liang
authors.forename: Hong-Yun
authors.initials: HY
authors.lastname: Gao
authors.forename: Zhi-Wei
authors.initials: ZW
authors.lastname: Yang
authors.forename: Fu-Jun
authors.initials: FJ
authors.lastname: Jia
authors.forename: Yue-Zhu
authors.initials: YZ
authors.lastname: Liang
authors.forename: Fang
authors.initials: F
authors.lastname: Fang
authors.forename: Rong
authors.initials: R
authors.lastname: Li
authors.forename: Sheng-Nan
authors.initials: SN
authors.lastname: Xie
authors.forename: Jian-Min
authors.initials: JM
authors.lastname: Zhuo
mesh_terms: D000284:Administration, Oral; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000503:physiopathology; D002648:Child; D003071:Cognition / Q000187:drug effects; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009483:Neuropsychological Tests; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D008774:Methylphenidate