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

Lee 2007.

Methods A cohort of methylphenidate use for 3 weeks plus 1 week baseline
Participants Number of participants screened: not stated
Number of participants included: 119
Number of participants followed up: 110
Number of withdrawals: 9
Diagnosis of ADHD: DSM‐IV (subtype: not stated)
Age: 8.5 (SD1.6) years (range 6‐13)
IQ: > 70
Sex: 107 males, 12 females
Methylphenidate‐naïve: not stated
Ethnicity: not stated
Country: South Korea
Comorbidity: oppositional behaviours (14.8%), conduct behaviours (2.3%), obsessive‐compulsive behaviours (0.8%), generalised anxiety symptoms (7.8%), depressive symptoms (12.5%), learning problems (18.8%)
Comedication: not stated
Sociodemographics: not stated
Inclusion criteria:
  1. Full diagnosis based on DSM‐IV criteria

  2. Moderate to severe level of impairment of ADHD symptoms

  3. Drug naïve or not medicated ≥ 6 months before the initiation of the study

  4. No abnormalities in baseline physical examination and routine laboratory tests

  5. In addition only participants who were able to comply with the study visit schedule were included


Exclusion criteria:
  1. Presence of clinically significant gastrointestinal problems, cardiovascular disease, glaucoma, seizure disorder, psychotic disorder, clinical depression or Tourette syndrome

  2. Suspicion or confirmation of substance abuse

  3. Receiving clonidine or other alpha‐2 adrenergic receptor agonists, tricyclic antidepressants, theophylline, coumarin or anticonvulsants

  4. IQ < 70 as determined by the Korean Wechsler Intelligence Scale for children

Interventions Methylphenidate type: osmotic release oral sytem (OROS)
Mean methylphenidate dosage: 0.87 mg/kg (SD 0.33)
Administration schedule: daily
Duration of intervention: 3 weeks
Treatment compliance: 2 participants discontinued trial due to protocol non‐compliance
Outcomes Non‐serious adverse events
  • 18‐item list of stimulant related AE symptoms (compiled by authors), self‐reported, days 7, 14 and 21

  • Physical examination, general chemistry tests, blood pressure, pulse rate, ECG; observer, baseline and end of study


1 respondent withdrew from trial during first week of trial on 18 mg OROS because of decreased appetite of moderate severity while another participant withdrew in the same period because of insomnia of mild severity
Notes Sample calculation: yes
Ethics approval: not stated
Funding/vested interests: funded by Janssen Korea
Key conclusions of the study authors: these data provide support for the benefit of the once daily methylphenidate preparation Concerta, in the treatment of Korean children with ADHD. Children were initiated safely in this short‐term trial, and its effectiveness was evident in the behavioural, as well as neuropsychological measurements
Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: not stated