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

Pliszka 2000.

Methods Single‐center, randomized, double‐blind, placebo‐controlled, parallel‐group trial
 Country: United States
Number of study sites: 1
 Statistical methods: modified ITT (last observation carried forward)
Participants Sample size: 59* children/adolescents with an ADHD diagnosis according to the Diagnostic Interview Schedule for Children
 Dropouts: 5
 Psychiatric comorbid disorders: oppositional defiant disorder, conduct disorder, anxiety
 Age range: 6 years to 10 years
 Mean age (SD): 8.2 (1.6) years
 Sex: NR
 ADHD subtype: NR
Interventions Three interventions (58 children/adolescents participated in one of three interventions):
  1. Mixed amphetamine salts (short acting), weight‐based, titrated dosing (maximum dose for children < 27.2 kg (60 lbs) was 15 mg/day; maximum daily dose for children/adolescents > 27.2 kg (60 lbs) was 30 mg/day), (n = 20)

  2. Methylpehnidate, weight‐based, titrated dosing (maximum dose for children < 27.2 kg (60 lbs) was 25 mg/day; maximum daily dose for children/adolescent > 27.2 kg (60 lbs) was 50 mg/day), (n = 20)

  3. Placebo (n = 18)


Duration: 21 days
Outcomes Relevant outcomes:
  1. ADHD core symptom severity, assessed with IOWA (inattention/overactivity with aggression) Conners' Teacher Rating Scale and Conners' Parent Global Index

  2. Clinical impression, assessed with Clinical Global Impressions ‐ Improvement scale

  3. Number of participants who dropped out due to any adverse event

  4. Adverse events


Other outcomes:
  1. Agression/defiance, assessed with Conners' Teacher Rating Scale

Notes ClinicalTrials.gov identifier: not available
Author's affiliation: university and pharmaceutical industry
 Study funding: pharmaceutical industry
 *1 participant dropped out before the end of the study, and was not accounted for in the participant characteristic description (data only provided on 58 participants)
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 Low risk Low attrition (10%), and reasons provided. All randomized children/adolescents included in primary analysis
Selective reporting (reporting bias) Unclear risk Study protocol not available and the possibility of reporting bias could not be assessed
Other bias Low risk Study appears to be free of other biases
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Intervention and placebo are described as identical
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Blinding of outcome assessment not described