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. 2023 Mar 27;2023(3):CD009885. doi: 10.1002/14651858.CD009885.pub3

Swanson 1998.

Study characteristics
Methods Randomised, double‐blind, cross‐over trial with 6 interventions:
  • MPH

  • Placebo

  • MAS (Adderall) in 4 different doses

    • 5 mg

    • 10 mg

    • 15 mg

    • 20 mg

Participants Number of participants screened: 36
Number of participants included: 33 (26 boys, 7 girls)
Number of participants followed up: 29
Number of withdrawals: 4
Diagnosis of ADHD: DSM‐IV (subtype not stated)
Age: mean 10.58 years (range 7‐14)
IQ: > 80
MPH‐naive: 0%
Ethnicity: not stated
Country: USA
Setting: outpatient clinic (laboratory classroom)
Comorbidity: none
Comedication: none
Other sociodemographics: none
Inclusion criteria
  • Age between 7 and 14 years

  • Diagnosis of ADHD by DSM‐IV

  • History of clinically significant response to typical doses of MPH (5 mg‐20 mg, twice/d or 3 times/d)


Exclusion criteria
  • BP outside 95th percentiles for age and sex

  • WISC‐II: score < 80

  • Abnormalities noted upon physical examination

  • Current treatment with a non‐stimulant medication for ADHD

  • Comorbid disorder

  • History of aggressive behaviour serious enough to preclude participation in regular classroom activities

Interventions Participants were randomly assigned to 1 of 36 possible drug condition orders of unknown dose of MPH, placebo and 4 doses of MAS (Adderall)
Mean MPH dosage: not stated
Administration schedule: once, morning
Duration of each medication condition: 7 days
Washout before trial initiation: not stated
Medication‐free period between interventions: none
Titration period: none
Treatment compliance: 30 of 33 participants completed the 7‐week trial
Outcomes ADHD symptoms
  • SKAMP Teacher Rating Scale, as modified by Greenhill into 2 domains of Attention and Deportment (i.e. positive behaviour): completed by 1 of the teachers after each 45‐min class period (i.e. every 1.5 h on the Saturday of each week, the teacher monitoring behaviour rated each student on each item)


Serious AEs
  • No unusual or serious side effects were noted in this trial


Non‐serious AEs
  • After each classroom period (6 times/d), teachers assessed each student on the MTA 10‐Item Stimulant Side Effects (SSE) rating scale

  • Parents completed a side effects rating scale that included Stimulant Side Effects items plus an additional item (trouble sleeping) 3 times/d, on Monday, Wednesday and Friday of each week

Notes Sample calculation: no
Ethics approval: not stated
Comments from trial authors
  • Laboratory classroom experience may represent a novel experience for participants, and this could alter response to medication

  • Group interactions in a classroom with 16 or 17 students with ADHD may be different from those in the typical classroom of 20‐30 students including 1‐2 children with ADHD

  • Behaviour of 16‐17 students with ADHD in a classroom with a student:teacher ratio of about 8:1 may be different from that in a classroom with the typical ratio of 20:1 to 30:1


Key conclusions of trial authors
  • "This documentation of efficacy in a controlled study supports the addition of MAS (Adderall) to the armamentarium of psychotropic medications for treatment of ADHD"

  • "Differences in time‐response patterns of MAS and MPH may help tailor treatment to meet specific clinical needs of different children with ADHD"


Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: yes; only known MPH responders were included
Any withdrawals due to AEs: no, not in the MPH or placebo group (2 in different MAS groups)
Funding source: grant from Richwood Pharmaceutical Company
Email correspondence with trial authors: January 2014. No reply has been received
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Latin‐square design (with provisions for 36 participants) was used to determine the within‐participant order of administration of the 6 medication conditions, so that for each of the first 6 weeks, approximately one sixth of participants would be assigned to each of the 6 conditions. Separate randomisation was used to determine assignment of conditions across participants for week 7, to provide an opportunity to make up missed weeks
Allocation concealment (selection bias) Unclear risk No information
Blinding of participants and personnel (performance bias)
All outcomes Low risk For each condition, a pharmacist prepared a set of 7 identical capsules, all containing placebo (lactose), 1 of the 4 doses of MAS or MPH
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No information
Incomplete outcome data (attrition bias)
All outcomes Unclear risk 30 of 33 participants completed the 7‐week trial; 98% of data were collected as planned. For each individual, missing data (1.1% for SKAMP, 0% for Stimulant Side Effects) were replaced by the average of values from adjacent time points (or adjacent values for session 1 or 6).
Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no
Selective reporting (reporting bias) Unclear risk No protocol available