Na 2013.

Methods	A 12‐week, open‐label, multicentre, phase 4 study of osmotic release oral system (OROS) methylphenidate use
Participants	Number of patients screened: not stated Number of participants included: 121 Number of participants followed up: 103 Number of withdrawals: 18 Diagnosis of ADHD: DSM‐IV (subtype: combined (17.4%), hyperactive‐impulsive (0.8%), inattentive (70.2%)) Age: mean: 13.8 years old (range: 12‐18) IQ: above 70 Sex: 93 males, 28 females Methlphenidate‐naïve: not stated Ethnicity: Korean Country: Korea Comorbidity: oppositional defiant disorder: 24%, conduct disorder: 5%, tic disorder: 4.1%, depressive disorder: 4.1%, social phobia: 1.7%, generalised anxiety disorder: 2.5%, enuresis: 1.7%, encopresis: 1.7%) Comedication: no Sociodemographics not stated Inclusion criteria DSM‐IV criteria for ADHD and considered to require medication therapy Participants that agreed to observe visit schedules and willingly complete the evaluation defined by participant (possibly to be completed by parents/guardians) during the treatment period Participants and parents/guardians that are able to understand the participation procedures of the research and spontaneously request the discontinuation therein at any time Participants that offered spontaneous consent for participation Participants whose guardian/legal representative provided spontaneous written consent 12‐18 years of age Exclusion criteria Hypersensitivity to methylphenidate HCL Participants diagnosed with major depression or anxiety disorders according to DSM‐IV diagnostic criteria and who requires drug therapy Significant suicidal ideation Learning disabilities or mental retardation, any history of bipolar disorder, psychotic disorder, or substance use disorder Diagnosed with a pervasive developmental disorder, organic brain disease, seizure disorder, and movement disorder requiring pharmacological treatment Family history of Tourette syndrome Previously taken OROS methylphenidate within 6 months before screening Severe general medical conditions (e.g. glaucoma, severe cardiovascular, hepatic, or renal illnesses), or clinically significant gastrointestinal problems, and Taking a‐2 adrenergic receptor agonists, theophylline, coumarin, antidepressants, antipsychotics, benzodiazepines, modafinil, anticonvulsants, or health supplements that may influence activity of the central nervous system at the time of screening Abnormalities in baseline physical examination or routine laboratory tests
Interventions	Methylphenidate type: osmotic‐release oral system (OROS) Methylphenidate dosage: dose titration was allowed for up to 6 weeks (starting doses were 18 mg/day (if body weight < 30 kg) and 27 mg/day (if body weight equal to or higher than 30 kg), maximum allowed daily dose was 72 mg or 1.4 mg/kg) Mean methylphenidate dose at endpoint: 54.53 (SD 12.33, range 27‐72) mg/day or 0.99 (SD 0.21) mg/kg/day Administration schedule: once a day, between 6:30 and 9:00 am Duration of intervention: 12 weeks Washout before study initiation: ≥ 6 months Treatment compliance: not stated, but participants were required to take ≥ 70% of the study medication during the study period
Outcomes	Non‐serious adverse events: Vital signs, body weight, and adverse events (both by general inquiry to patients and parents and by clinician rated checklist) were measured at every visit (day 0 (baseline) and at weeks 1, 3, 6, and 12) The study‐specific adverse events checklist consisted of 61 methylphenidate‐specific questions (Items from the Symptom Rating Scale (Barkley 1990) and the Pittsburg Side‐Effects Rating Scale (Pelham 1993) were included) Chemistry tests were performed at screening and at week 12
Notes	Sample calculation: not stated Ethics approval: yes, the study was approved by the institutional review board of each study site Funding: this study was supported by grants from the Johnson & Johnson family of companies. The Johnson & Johnson family of companies was involved in the study design and approved the report Vested interests: disclosure statement "No competing financial interests exist". Key conclusions of the study authors: OROS methylphenidate was effective in enhancing learning skills in adolescents with ADHD. Furthermore, clinicians should supplement the subjective report on adverse events from patients or their parents with a more drug‐specific checklist to obtain drug side effects more effectively. As there are some differences in the patterns of adverse events reported by patients and their parents, it is generally recommended that clinicians obtain information from both parties when possible Comments from the review authors: safety data comparing patients, parents and clinicians as raters from Lee 2013 concerns only 47 participants, whereas efficacy data and supplemental safety data from Na 2013 concerns 121 participants Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: yes, see exclusion criteria no. 1 (hypersensitivity to methylphenidate HCL) Supplemental information regarding safety data received through personal email correspondence with the authors in August 2014 (Lee 2014 [pers comm])