Skip to main content
. 2023 Mar 27;2023(3):CD009885. doi: 10.1002/14651858.CD009885.pub3

Solanto 2009.

Study characteristics
Methods Cross‐over trial with 2 interventions:
  • MPH

  • placebo


Phases: week‐long exposure to placebo and to each of 3 different dosage regimens of IR‐MPH
Participants Number of participants screened: not stated
Number of participants included: 30
Number of participants followed up: 25
Number of withdrawals: 5
Diagnosis of ADHD: DSM‐IV (combined (60%), inattentive (40%))
Age: mean 8.53 (combined) and 9.20 (inattentive)
IQ: not stated
MPH‐naive: all but 1 were stimulant‐naive
Ethnicity: not stated
Country: USA
Setting: hospital
Comorbidity: ODD (combined 13%, predominantly inattentive 20%); learning disability (combined 40%, predominantly inattentive 20%); anxiety (combined 0%, predominantly inattentive 10%)
Comedication: no
Other sociodemographics: minority representation (combined 53%, predominantly inattentive 20%)
Inclusion criteria
  • Between 7 and 12 years of age

  • Concordant reports: CPRS and CTRS ‐ Combined group T scores ≥ 65 on both DSM‐IV Inattentive and DSM‐IV Hyperactive‐Impulsive Scales

  • Predominantly Inattentive group T scores ≥ 65 on the DSM‐IV Inattentive Scale and < 65 on the DSM‐IV Hyperactive‐Impulsive scale

  • Diagnosis of ADHD, combined or predominantly inattentive according to a structured diagnostic interview of the parent: DISC

  • Expert clinical diagnosis of ADHD based on review of all information collected


Exclusion criteria
  • Currently receiving psychotropic medication

  • WISC‐III: < 80

  • Mood disorder, Tourette's disorder or psychotic disorder

  • Sensory impairment or chronic medical or neurological condition including asthma that required systemic medication

  • Colour blindness

Interventions Participants were randomly assigned to 1 of 24 possible drug condition orders of LD‐, MD‐ and HD‐MPH and placebo
Mean MPH dosage (Combined vs predominantly Inattentive): LD 0.50 ± 0.12 vs 0.44 ± 0.13; MD 0.83 ± 0.20 vs 0.73 ±‐0.21; HD 1.54 ± 0.31 vs 1.40 ± 0.38
Administration schedule: 3 times daily: morning, midday and 3:00 pm
Duration of each medication condition: 1 week
Washout before trial initiation: not required
Medication‐free period between interventions: no
Titration period: open‐label lead‐in week, not specified whether before or after randomisation of treatment
Treatment compliance: not stated
Outcomes ADHD symptoms
  • CPRS, parent and teacher: baseline and end of each medication phase

  • CTRS, parent and teacher: baseline and end of each medication phase

  • ADHD‐RS‐IV: observer, weekly


Non‐serious AEs
  • Height, weight and vital signs: observer, weekly

  • Side Effects Rating Scale: observer, weekly

Notes Sample calculation: no
Ethics approval: not stated
Key conclusion of trial authors
  • "Results support the clinical utility of MPH in the treatment of predominantly inattentive subtype and provide no evidence of differences in response between subtypes"


Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: unclear if there was an open‐label titration phase before randomisation
Any withdrawals due to AEs: yes; 2
Funding source: not declared
Email correspondence with trial authors: April 2014. We received supplemental information from trial authors
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not stated
Allocation concealment (selection bias) Low risk Double‐blind, cross‐over with week‐long exposure to placebo and each of 3 different dosage regimens of IR‐MPH in randomly assigned order
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, cross‐over with week‐long exposure to placebo and each of 3 different dosage regimens of IR‐MPH in randomly assigned order. Trial medications were prepared and coded by the hospital pharmacy using identical gelatin capsules for active medication and placebo
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not stated
Incomplete outcome data (attrition bias)
All outcomes Low risk Across the 4 placebo and drug conditions, data points were missing as follows: CPRS 1%, CTRS 6%, Parent SKAMP 1%, Teacher SKAMP 4%, Side Effects 0%. Missing scores were replaced by the mean of scores for that group in that condition
Selection bias: titration conducted but unclear whether before or after randomisation. No participants were excluded after the 1‐week titration period
Selective reporting (reporting bias) Low risk Protocol identified; all outcomes reported