Kim 2015b.
Methods | A prospective, multicentre, open‐label cohort study of 116 children with ADHD treated with OROS methylphenidate for 12 weeks | |
Participants | Number of participants screened: not stated Number of participants included: 143 Number of participants followed up: 116 Number of withdrawals: 27 Diagnosis of ADHD: DSM‐IV (subtype: combined (36.2%), hyperactive‐impulsive (5.2%), inattentive (33.6%), NOS (25%)) Age: mean 9.4, range: 6‐18 years old IQ: mean 108.9 (SD 16.0) Sex: 100 males, 16 females Methylphenidate‐naïve: 89.7% Ethnicity: not stated Country: Korea Comorbidity: depression (5.2%), anxiety (7.7%), tic disorder (7.7%), ODD (10.3%) Comedication: not stated Sociodemographics: not stated Inclusion criteria
Exclusion criteria
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Interventions | Methylphenidate type: osmotic release oral system (OROS) Mean methylphenidate dosage: average daily dose increased from 19.20 (SD 3.11) mg/d (0.64 (SD 0.18) mg/kg per day) at week 1 to 34.13 (SD 13.80) mg/d (1.03 (SD 0.3318) mg/kg per day) at the end of 12 weeks of dosing Administration schedule: not stated Duration of intervention: 12 weeks Treatment compliance: 12 patients dropped out because of medication non‐compliance |
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Outcomes | 8 participants dropped out because of adverse events (29.6%) | |
Notes | Sample calculation: no Ethics approval: yes Funding: this study has been sponsored by Janssen, Korea Vested interests/authors' affiliations: the authors have no conflicts of interest to declare. Key conclusions of the study authors: treatment with OROS‐MPH was associated with symptomatic functional changes that were moderately correlated; therefore, symptomatic functional outcomes appear to be partially overlapped but distinct domains. Consequently, functional measures should be incorporated as important outcome measures in future treatment studies; the importance of treatments targeting functional improvement should be emphasised in the treatment of children with ADHD Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: no Supplemental information regarding adverse events requested through personal email correspondence with the authors in June 2016 with no reply |