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

Kim 2010.

Methods Single‐site, 6‐week, prospective, open‐label, flexible‐dose trial with osmotic release oral system methylphenidate (Concerta) monotherapy to examine OROS‐MPH effect on sleep in children with ADHD. Examination by physician at baseline, participants were seen at the first, second, fourth, and sixth weeks for repeated clinical evaluation and dosage titration
Participants Number of participants screened: not stated
Number of participants included: 27
Number of participants followed up: 24
Number of withdrawals: 3
Diagnosis of ADHD: DSM‐IV (subtype: combined (66.7%), hyperactive‐impulsive (4.2%), inattentive (29.2%))
Age: mean 8.2 (SD 1.4) years
IQ: mean 105 (SD 11.5)
Sex: 22 males, 2 females
Methylphenidate‐naïve: 100%
Ethnicity: not stated
Country: South Korea
Comorbidity: ODD: 2 (9.1%)
Comedication: no medications that might influence clinical status or sleep characteristics were permitted
Sociodemographics: family history of ADHD: 4, 16.7%
Inclusion criteria:

  1. Age 6‐12 years

  2. DSM‐IV diagnosis of ADHD

  3. Clinical Global Impression‐Severity (CGI‐S) scale rating ≥ 4 ('moderately ill' or greater severity)

  4. Normal medical history screening and physical examination

  5. Patients and parents who were informed and voluntarily provided consent


Exclusion criteria:

  1. Earlier exposure to a central nervous system stimulant within the previous 3 months.

  2. Hypersensitivity to methylphenidate

  3. IQ < 80 on the Korean Educational Developmental Institute's Wechsler Intelligence Scale for Children

  4. Presence of comorbid psychiatric disorders except for oppositional defiant disorder (ODD).

  5. Past and/or current history of developmental disorder, including autism spectrum disorder

  6. Presence of seizure disorder

  7. Presence of significant comorbid medical illness.

  8. No medications that might influence clinical status or sleep characteristics were permitted
Interventions Methylphenidate type: osmotic release oral system (OROS)
Methylphenidate dosage: the mean daily dose at week 6 was 29 (SD 6.8, range 18‐45) mg or 1.08 (SD 0.24) mg/kg
Administration schedule: once daily
Duration of intervention: 6 weeks
Treatment compliance: not stated
Outcomes Non‐serious adverse events:
Children's Depression Inventory, rated by parents
State Trait Anxiety Inventory (STAI), rated by parents
Yale Global Tic Severity Scale, rated by parents
Barkley Side Effect Rating Scale, rated at 1st, 2nd, 4th and 6th week by parents
Questions to parents about adverse events at each follow‐up visit (1st, 2nd, 4th and 6th week)
Children's Sleep Habits Questionnaire (CSHQ), measured at week 6
Height measured at week 1st, 2nd, 4th and 6th week
Weight measured at week 1st, 2nd, 4th and 6th week
Blood pressure measured at week 1st, 2nd, 4th and 6th week
Heart rate measured at week 1st, 2nd, 4th and 6th week
EKG measured at week 6
Overnight polysomnography measured at week 6
Apnea and hypopnea, scored according to the recommended criteria of the American Academy of Sleep Medicine at week 6. Apnea was defined as an absence of oronasal airflow with minimal interval of 2 respiratory cycles. Hypopnea was defined as 50% air flow reduction or more for ≥ 2 respiratory cycles resulting in EEG arousals or oxygen desaturation (Z3%)
Notes Sample calculation: not stated
Ethics approval: yes
Funding/vested interests: sponsored by Janssen Korea
Key conclusions of the study authors: these results suggest that OROS MPH in open‐label treatment does not appear to impair sleep on either qualitative measures of sleep or sleep architecture and may improve some aspects (including sleep quality)
Comments from the study authors: no significant effects were found on any laboratory tests and EKG. Another important finding indicated that children who experienced subjective sleep difficulties showed increased sleep onset latency, sleep onset delay, and bedtime resistance compared with those without sleep complaints during treatment
Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: no. All participants were methylphenidate‐naïve
Supplemental information regarding outcome measures requested in February 2014. No reply