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

James 2001.

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: 35 children/adolescents with an ADHD diagnosis according to DSM‐IV criteria
 Dropouts: NR
 Psychiatric comorbid conditions: oppositional defiant disorder, anxiety, enuresis, dysthymic disorder, learning disorder
 Age range: 6.9 years to 12.2 years
 Mean age (SD): 9.1 (1.5) years
 Sex: 21 (60%) males
 ADHD subtype: 35 (100%) combined
Interventions 4 interventions:*

  1. Dextroamphetamine (short acting)*

  2. Dextroamphetamine spansules (long acting)*

  3. Mixed amphetamine salts (long acting)*

  4. Placebo


Duration: 56 days (4 x 14‐day treatment periods)
Outcomes Relevant outcomes:

  1. ADHD core symptom severity, assessed with Conners' Teacher Rating Scale and Conners' Parent Rating Scale

  2. Academic performance, assessed with a 5‐minute timed math task

  3. Adverse events


Other outcomes:

  1. Motor activity, assessed with an actometer
Notes ClinicalTrial.gov identifier: not available
Authors' affiliation: National Insitute of Mental Health
 Study funding: NR
 *Doses were individualized and based on age, weight, prior medication experience and symptom severity (overall mean dose range: 7.8 mg/day to 12.8 mg/day)
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 (7%), and reasons provided. All dropouts occurred prior to randomization. All randomized children/adolescents completed the trial and 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 described as identical
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Blinding of outcome assessment not described