Sobanski 2013.

Methods	A cohort study of methylphenidate use for 6‐12 weeks
Participants	Number of participants screened: not stated Number of participants included: 381 Number of participants followed up: 347 Number of withdrawals: 34 Diagnosis of ADHD: ICD‐10 (subtype: combined (64.8%), hyperactive‐impulsive (32.3%), inattentive (2.6%)) Age: mean 14.0 years old (range: 12‐17) IQ: not stated Sex: 307 males, 74 females Methylphenidate‐naïve: 7.3% Ethnicity: not stated Country: Germany Comorbidity: speech and language disorders and learning disabilities (8.9%), depressive disorders (3.1%) and anxiety disorders (2.4%). Asperger's syndrome (1%) tic disorders (1.3%) Comedication: yes, 42 patients (11%) (type: not stated) Sociodemographics: not stated Inclusion criteria: Male and female patients between 12 and 17 years Confirmed ADHD diagnosis according to ICD‐10 Treatment‐naïve patients with indication for treatment with Medikinet retard or previously treated patients with indication for switch of medication to Medikinet retard Exclusion criteria: Contraindications against Medikinet retard according to the summary of product characteristics (SPCs) Comorbid psychiatric or somatic disorder
Interventions	Methylphenidate type: Medikinet retard (50% extended‐release component) Mean methylphenidate dosage: 35.7 (SD 15.1, range 5‐120) mg/d, and at end point 0.7 (SD 0.3, range 0.2‐2.8) mg/kg of the body weight Administration schedule: all patients received Medikinet retard in the morning, 16% received a second dose at lunchtime and 4% on a pro re nata basis Duration of intervention: the median observational period for the treatment with Medikinet retard was 70 days Treatment compliance: not stated
Outcomes	Adverse events were assessed by spontaneous report during the clinical interview at each visit (at T1 and T2)
Notes	Sample calculation: no Ethics approval: yes Funding/vested interest/authors affiliations: the study was funded by Medice. Esther Sobanski has received consulting income and research support from Eli Lilly, Medice, Novartis and Shire and research support from the German Research Foundation, German Ministry of Education and Research. She receives royalties from books by Medizinisch Wissenschaftliche Verlagsgesellschaft and Dansk Psykologisk Forlag. Manfred Dopfner received consulting income and research support from Lilly, Medice, Shire and Vifor and research support from the German Research Foundation, German Ministry of Education and Research. He receives royalties from books and psychological tests published by Hogrefe, Beltz and Huber. Claudia Ose has received an unrestricted educational grant for statistical and administrative support from Medice. Roland Fischer is the medical director of Medice Key conclusions of the study authors: the findings suggest that pharmacologically treated adolescents with ADHD and insufficient symptom reduction and/or treatment adherence benefit from switching to Medikinet retard and that it is well tolerated when given in clinical routine care Comments from the study authors: adverse events were assessed by spontaneous reports but not by the use of structured measures possibly resulting in underreporting. Most patients that were included in the study had an indication for a medication switch. Thus, the study does not allow for conclusions about general effectiveness or superiority of Medikinet retard compared to alternative medications Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: not stated Supplemental information on adverse events requested through personal email correspondence with the authors in July 2014 (Sobanski 2014 [pers comm]). Authors not able to provide further information