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

Short 2004.

Methods Single‐center, randomized, double‐blind, placebo‐controlled, cross‐over trial
 Country: United States
Number of study sites: 1
 Statistical methods: per protocol
Participants Sample size: 34* children/adolescents with an ADHD diagnosis according to DSM‐IV criteria
 Dropouts: NR
 Psychiatric comorbid conditions: NR
 Age range: 3 years to 5.9 years
 Mean age (SD): 5.3 (NR) years
 Sex: 24 (85%) males
 ADHD subtype: 5 (17%) inattentive; 23 (83%) hyperactive ‐ impulsive or combined
Interventions Two conditions (28 children/adolescents participated in one of two conditions)*:
  1. Amphetamine:

    1. Mixed amphetamine salts (short acting), 5 mg/day, once daily

    2. Mixed amphetamine salts (short acting), 10 mg/day, once daily

    3. Mixed amphetamine salts (short acting), 15 mg/day, once daily

    4. Placebo

  2. Methylphenidate:

    1. Methylphenidate, 5 mg/day, twice a day

    2. Methylphenidate, 10 mg/day, twice a day

    3. Methylphenidate, 15 mg/day, twice a day

    4. Placebo


Amphetamine or methylphenidate determined by a physician
 Duration: 28 days (4 x 7‐day treatment periods)
Outcomes Relevant outcomes:
  1. ADHD core symptom severity, assessed with Conners' Parent Rating Scale‐short form and Conners' Teacher Rating Scale‐short form**

  2. Adverse events

Notes ClinicalTrial.gov identifier: not available
Authors' affiliations: university
 Study funding: public funds
 *Clinical characteristics only presented on children/adolescents included in analysis (n = 28)
 **The authors did not separate the two active interventions (amphetamine and methylphenidate) in their analysis. We contacted the authors on three occasions to obtain the data on amphetamines only, but we received no response, and therefore outcomes could not be included in 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 sufficiently described
Incomplete outcome data (attrition bias) 
 All outcomes High risk Reasons for attrition not described. In addition, six participants were dropped from the analysis, and their last data point was not carried forward
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 described as identical
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcome assessors blinded to order of trial interventions