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. 2018 May 10;2018(5):CD012069. doi: 10.1002/14651858.CD012069.pub2

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
  1. Participants who are diagnosed with ADHD according to DSM‐IV

  2. Participants who have been treated with immediate‐release methylphenidate for ≥ 4 weeks before enrolment, but previous treatment is considered unsatisfactory due to ≥ 1 of the following reasons: lack of effectiveness, lack of tolerability or safety, lack of compliance, and/or other reasons

  3. Participants who are able to comply with the study visit schedule and whose parents/caregiver and community school teacher are willing and able to complete the protocol‐specified assessments

  4. Participants who are still at school

  5. Participants who are treated with ≥ 10 mg immediate release methylphenidate daily before enrollment


Exclusion criteria
  1. Cannot understand or follow the instructions given in the study

  2. Serious or unstable medical illness

  3. Clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract

  4. Gaucoma, an ongoing seizure disorders, or a psychotic disorder

  5. Hypersensitive to methylphenidate

  6. Any co‐existing medical condition or are taking a concomitant medication that is likely to interfere with safe administration of methylphenidate

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
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