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. 2016 Feb 4;2016(2):CD009996. doi: 10.1002/14651858.CD009996.pub2

Ramtvedt 2013.

Methods Multi‐center, randomized, placebo‐controlled, cross‐over trial
 Country: Norway
 Number of study sites: 4
 Statistical methods: unclear
Participants Sample size: 36* children/adolescents with an ADHD diagnosis according to DMS‐IV‐TR criteria
 Dropouts: 0
 Psychiatric comorbid disorders: oppositional defiant disorder, anxiety/depression, learning disability
 Age range: 9 years to 14 years
 Mean age (SD): 11.4 (1.4) years
 Sex: 29 (81%) males
 ADHD subtype: 10 (28%) inattentive; 1 (3%) hyperactive ‐ impulsive; 25 (69%) combined
Interventions Three interventions (all 36 children/adolescents participated in each of the three interventions):
  1. Dextroamphetamine (short acting), 5 mg twice a day in week 1; 10 mg twice a week in week 2, (n = 36)

  2. Methylphenidate (short acting): 10 mg three times a day in week 1; 15 mg twice a day, 10 mg once daily in week 2, (n = 36)

  3. Placebo (n = 36)


Duration: 42 days (3 x 14‐day treatment periods)
Outcomes Relevant outcomes:
  1. Improvement of ADHD symptoms, assessed with a 21‐item ADHD questionnaire developed for the study by parents and teachers**

  2. Adverse events


Other outcomes:
  1. Inattention, assessed with Conners' Continuous Performance Test

  2. Motor activity, assessed with Conners' Continuous Performance Test

Notes ClinicalTrials.gov identifier: NCT01220440Authors' affiliation: university and hospital
 Study funding: public funds
 Outcomes were presented across two publications
*Data only provided on those children/adolescents who completed the trial; no information provided regarding number of children/adolescents randomized
 **Data is presented as an aggregate score of parent and teacher ratings and therefore could not be incorporated into the meta‐analysis
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of sequence generation not described
Allocation concealment (selection bias) Unclear risk Method of allocation concealment not described
Incomplete outcome data (attrition bias) 
 All outcomes High risk Primary analysis only included a subset of completers without any reason provided. No information on non‐completers provided
Selective reporting (reporting bias) High risk Although the registered protocol stated that they would collect adverse events using the Side‐Effects Rating Scale, this was not reported in the published manuscript
Other bias Unclear risk No information on the validity of the primary outcome measure provided
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Interventions and placebo were not identical
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Blinding of outcome assessment not described