Ramtvedt 2013.

Study characteristics
Methods	6‐week, cross‐over trial with 3 interventions: MPH placebo dextroamphetamine Phases: 3
Participants	Number of participants screened: not stated Number of participants included: 36. Number of participants followed up: 36 (29 boys, 7 girls) (n = 34 for AE data) Number of withdrawals: 0 Diagnosis of ADHD: DSM‐IV‐TR (combined (69%), hyperactive‐impulsive (3%), inattentive (28%)) Age: mean 11.4 years (range 9‐14) IQ: mean 90.9 MPH‐naive: 100% Ethnicity: not stated Country: Norway Setting: outpatient clinic Comorbidity: anxiety/depressive disorder (n = 9, 25%), ODD (n = 20, 55%), learning disability (n = 22, 61%) and Asperger syndrome (n = 1, 3%) Comedication: no Other sociodemographics: none Inclusion criteria ADHD diagnosis rated as > 2 SD above the mean on the CRS, DSM‐IV Inattention and/or DSM‐IV Hyperactivity‐Impulsivity subscales Between 9 and 14 years of age No prior treatment with stimulants Stimulant treatment that has been approved by a paediatrician or psychiatrist Exclusion criteria Moderate to severe mental disability Psychosis Brain injury Sensory deficits, motor impairment or both Epilepsy Factors that would substantially reduce the possibility of obtaining reliable observations from a parent or teacher
Interventions	Participants were randomly assigned to 1 of 6 possible drug condition orders of MPH (30 mg/d‐40 mg/d), dextroamphetamine (10 mg/d‐20 mg/d) and placebo Mean MPH dosage: not stated Administration schedule: MPH, 3 time points (morning, lunch and afternoon); dextroamphetamine, 2 time points (morning and afternoon) Duration of each medication condition: 2 weeks (1st week: low dose (30 mg/d), 2nd week: high dose (40 mg/d)) Washout before trial initiation: no; all were stimulant‐naive Medication‐free period between interventions: yes; Saturday and Sunday (48 h) Titration period: 2 weeks initiated after randomisation Treatment compliance: not stated
Outcomes	ADHD symptoms DSM‐IV Inattention and Hyperactive‐Impulsive subscales from CRS – Revised, Long Version, Parent and Teacher Forms 21‐item ADHD questionnaire was developed for this trial (8 items reflecting inattention, 6 items reflecting hyperactive‐impulsive behaviour and 4 items reflecting oppositional defiant behaviour), completed daily from Monday to Friday, every week by parents and teachers (Ramtvedt 2013) Children's self‐report scale ‐ developed for this trial: 8 items, rated weekly by the children themselves General behaviour CBCL Teacher Rating Form ADHD questionnaire ‐ Inattentive subscale, teacher‐rated Non‐serious AEs Barkley Side Effect Rating Scale: parents were instructed to rate side effects in co‐operation with their child at the end of each week during the trial
Notes	Sample calculation: not stated Ethics approval: yes Comments from trial authors Drugs were not camouflaged in identical capsules, increasing the risk for identification of drug order In only 1 case, a parent identified the drug order with certainty. That particular child was removed from the study ADHD questionnaire, used to rate ADHD symptoms during the stimulant trial, was developed for this study and cannot be considered equivalent to well‐established ADHD‐RSs Sample size might not have been sufficient to detect subtle differences between stimulants at the group level Key conclusions of trial authors MPH and dextroamphetamine were significantly effective. No significant superiority of 1 stimulant over the other was detected at the group level AEs associated with dextroamphetamine vs MPH appear similar at the group level but may differ substantially in individual children Overall, insomnia and decreased appetite were significantly associated with stimulants Comments from review authors This does not seem to be a particularly useful paper because the main point (not explicitly stated) was to obtain an equivalence for the QbTest (measures the 3 core signs of ADHD). As a result of this, the medication regimen was dedicated to find the best effects of both medications Trial authors stated that the primary outcome measure was developed for the study and cannot be considered equivalent to known ADHD‐RSs. Therefore, we have not used the data on ADHD symptoms in our analyses Inclusion of MPH responders only/exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: no Any withdrawals due to AEs: no Funding source: first phase was conducted as part of ordinary clinical practice at Neuropsychiatric Unit, Østfold Hospital Trust. Second and third phases, data analysis and preparation of manuscript were sponsored by South‐Eastern Norway Regional Health Authority, and also by Østfold Hospital Trust and National Resource Centre for ADHD, both under the umbrella of South‐Eastern Norway Regional Health Authority Email correspondence with trial authors: April 2015. We obtained supplemental information or data regarding comedication, randomisation and blinding
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were randomly and evenly assigned to each of 6 possible drug orders. "The children were assigned to the 6 possible drug condition orders by drawing numbers"
Allocation concealment (selection bias)	Unclear risk	Not clear
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants, parents, teachers and test administrators were blinded to drug order. 1 parent identified the drug order. Tablets of similar colours, shapes and textures were administered, but the drugs were not camouflaged in identical capsules
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not stated Selection bias (e.g. titration after randomisation → exclusion): no
Selective reporting (reporting bias)	Unclear risk	No access to protocol