Chou 2012b.
Methods | A prospective, single‐arm, open‐label, 8‐week, multicentre cohort study of methylphenidate use for 8 weeks | |
Participants | Number of participants screened: not stated Number of participants included: 296 Number of participants followed up: 230 Number of withdrawals: 66 Diagnosis of ADHD: DSM‐IV (subtype: combined (67.9%), hyperactive‐impulsive (1%), inattentive (30.4%)) Age: mean 9.5 (SD 2.4), range 6.0‐17.0 years old IQ: not stated Sex: 247 males, 49 females Methylphenidate‐naïve: none Ethnicity: not stated Country: Taiwan Comorbidity: participants with serious or unstable medical illness, or who have clinically significant gastrointestinal problems, glaucoma, ongoing seizure disorders, or a psychotic disorder are excluded Comedication: participants who are taking concomitant medication that is likely to interfere with safe administration of methylphenidate are excluded. Sociodemographics: not stated Inclusion criteria
Exclusion criteria
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Interventions | Methylphenidate type: osmotic release oral system (OROS) Methylphenidate dosage: 18 mg, 36 mg or 54 mg. Dose was adjusted for each participant based on clinical responses and/or side effects Administration schedule: once daily Duration of intervention: 8 weeks Treatment compliance: not stated |
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Outcomes | Adverse events (AEs) data were reported for each visit as total data for AEs; not analysed. In addition to the AEs reported in the below table, a category of AEs titled 'Other' was reported, as no dictionary was used and events under this category were not further specified. Total no. affected by other AEs is minimum number of participants affected | |
Notes | Sample calculation: not stated Ethics approval: not stated Funding: sponsored by Johnson & Johnson Taiwan Ltd Vested interests/authors' affiliations: principal investigators are not employed by the organisation sponsoring the study. There is an agreement between principal investigators and the sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo Key conclusions of the study authors: comparing with the baseline, OROS‐methylphenidate had been demonstrated that it could significantly improve participants' ADHD behavioural symptoms and their social adjustment at school and at home Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: participants hypersensitive to methylphenidate were excluded Supplemental information regarding IQ requested through personal email correspondence with the authors in August 2014 with no reply |