Montañés‐Rada 2012.

Methods	An 8‐week prospective, open‐label cohort study of participants receiving 8 hours extended release methylphenidate
Participants	Number of patients screened: 60 Number included: 40 Number followed up: 40 Number of withdrawals: 0 Diagnosis of ADHD: DSM‐IV‐TR (subtype: not stated) Age: mean: 13.6 years old (range: 10‐16) IQ: above 100 Sex: 30 males, 10 females Methylphenidate‐naïve: not stated Ethnicity: not stated Country: Spain Comorbidity: ODD: 75%, anxiety disorder: 10%, Gilles de la Tourette syndrome: 2.5%, no comorbidity: 20% Comedication: not stated Sociodemographics: low socioeconomic status: 37.5%, medium socioeconomic status: 50%, high socioeconomic status: 12.5% Inclusion criteria: 10‐16 years old Admitted to a child psychiatric consultation Not candidate for atomoxetine (sufficient response to stimulant treatment) Not candidate for immediate‐release methylphenidate because of prior poor tolerance (but at least with a partial response to Concerta or Medikinet) Not candidate for a short‐acting methylphenidate (4 hours) Candidate for taking methylphenidate with effect from 8 am to 9 pm defined as: patients attending school from 8 am to 3 pm or 8 am to 5 pm and needing supplemental support of stimulant treatment, and furthermore, also studying in the afternoon (at school or at home) (60%), or having challenging conduct problems and needing an extended effect until at least 9 pm (20%) or both situations Either moderate or severe in symptomatology according to the 20 items Conners Scale for teachers (above 45) and Clinical global impression scale (above or equal to a severity of 5 to 7) when off medication IQ above 70 Exclusion criteria: None stated
Interventions	Methylphenidate type: Medikinet (50% extended release and 50% immediate release methylphenidate) Methylphenidate dosage: 40‐50 mg/daily Administration schedule: twice daily. A fixed dose of 30 mg at breakfast (8:30 am) and either 10 mg (n = 34) or 20 mg (n = 6) in the afternoon (3:00 pm) Duration of intervention: 8 weeks (1 month of titration) Treatment compliance: not stated
Outcomes	Non‐serious adverse events: Insomnia, spontaneous reported
Notes	Sample calculation: not stated Ethics approval: not stated Funding/vested interests: HB Pharma Key conclusions of the study authors: at week 8, 63% of the participants reached complete remission, and 27.5% reached partial remission. Scores in all subscales of Eyberg, Conners (parents and teachers) were reduced till the level of normal population (except for the conduct subscale of the teacher rated) in a statistical significant level. Due to insomnia, 2 patients reduced the afternoon dose of 50/50‐ER/IR‐MPH from 20 mg to 10 mg and 3 patients changed the 20 mg 50/50‐ER/IR‐MPH afternoon dose to 10 mg IR‐MPH Comments from the study authors: our sample is representative of patients with moderate and severe symptomatology Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: see inclusion criteria 4‐6 Supplemental information regarding ADHD diagnostic criteria and IQ received through personal email correspondence with the authors in November 2013 (Montañes‐Rada 2013 [pers comm]) The publications on this study were received from the pharmaceutical company HB Pharma in June 2013 (Fischer 2013 [pers comm])