Remschmidt 2005.

Methods	A 21‐day multicentre, open‐label study of osmotic release oral system (OROS) methylphenidate in children and adolescents with ADHD switched from immediate release (IR) methylphenidate followed by a 12‐month follow‐up
Participants	Number of participants screened: not stated Number of participants included in the main study: 105 Number of participants followed up: 101 Number of withdrawals: 4 Number of participants included in the follow‐up: 89 Number of participants followed up: 56 Number of withdrawals: 33 Diagnosis of ADHD: DSM‐IV (subtype: combined (69.5%), hyperactive‐impulsive (7.6%), inattentive (22.8%)) Age: range 6‐16 years old IQ: not stated Sex: 90 males, 15 females Methylphenidate‐naïve: none Ethnicity: not stated Country: UK and Germany Comorbidity: not stated Comedication: not stated Sociodemographics: not stated Inclusion criteria Children and adolescents aged 6‐16 years DSM‐IV diagnosis of ADHD Receiving MPH‐IR for ≥ 4 weeks (10‐60 mg/day) and the most recent dose for ≥ 3 weeks Able to comply with study visit schedules Agree to take only the supplied study medication during the study Parents/caregivers and teachers had to be willing to complete assessments Participants who 'benefited' from OROS‐methylphenidate could continue in a 12‐month extension period Exclusion criteria: Known hypersensitivity to methylphenidate Clinically significant gastrointestinal problems, glaucoma, a seizure or psychotic disorder, Tourette syndrome, cardiovascular disease including moderate to severe hypertension, hyper‐excitability or agitated state, hyperthyroidism, depression, known or suspected substance abuse (current or past) Females who had reached menarche Participants receiving ≥ 1 of the following: clonidine, other alpha‐2 adrenergic receptor agonists, tricyclic antidepressants, theophylline, coumarin or anticonvulsants, monoamine‐oxidase inhibitors
Interventions	Methylpenidate type: osmotic release oral system Methylphenidate dosage: 18 mg, 36 mg, or 54 mg. 11.9% received 18 mg; 54.4% received 36 mg, and 33.7% received 54 mg at the end of the 21‐day main study Administration schedule: once daily, morning Duration of intervention: main study: 21 days, follow‐up: 12 months Treatment compliance: not stated
Outcomes	Non‐serious adverse events: Reports of any adverse events, sleep and appetite patterns, and tics were reported by parents/caregivers up to day 21, and at months 2, 4, 6, 8, 10 and 12
Notes	Sample calculation: not stated Ethics approval: independent Ethics Committees in each country reviewed the study protocol Funding/vested interest: this company‐initiated study was supported by a grant from Janssen‐Cilag GmbH Key conclusions of the study authors: children and adolescents can effectively and safely be switched from IR‐methylphenidate to OROS‐methylphenidate with improved symptom control and compliance Comments from the study authors: current international guidelines recommend the use of long‐acting stimulant preparations over short‐acting stimulants for the management of ADHD. The results of this study provide further support for this recommendation. These data cannot necessarily be generalised to unselected children and adolescents in clinical practice who may not be responsive to methylphenidate Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: yes Supplemental information requested from the review authors in June 2014 with no reply