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

Bliznakova 2007.

Study characteristics
Methods 11‐day N‐of‐1 randomised, double‐blind, cross‐over trial with 2 interventions:
  • MPH

  • placebo

Participants Number of participants screened: 1 boy
Number included: 1
Number of participants followed up: 1
Number of withdrawals: 1
Diagnosis of ADHD: ICD‐10 (predominantly hyperactive type)
Age: 15 years
IQ: not stated
MPH‐naive: no
Ethnicity: not stated
Country: Germany
Setting: not stated
Comorbidity: not stated
Comedication: not stated
Other sociodemographics: 2 parents
Interventions The participant was randomly assigned to MPH and placebo across 11 days
Mean MPH dosage: not stated
Administration schedule: not stated
Duration of each medication condition: the condition was changed daily, but placebo was given for 6 days and MPH for 5 days
Washout before trial initiation: not relevant
Medication‐free period between interventions: none
Titration period: none
Treatment compliance: 100% according to Table 7
Outcomes ADHD symptoms
  • CTRS: rated daily

  • Parent/Teacher Rating Scale: rated daily


Non‐serious AEs
  • Assessment of stomachaches (yes/no) daily

Notes Sample calculation: yes
Ethics approval: not stated
Key conclusion of trial authors
  • Double‐blind trial showed significant symptom reduction under the medication condition, which was also noted by the participant himself. Furthermore, towards the end of the trial, the somatic complaints were gone


Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: no
Any withdrawals due to AEs: no
Funding source: not stated
Email correspondence with trial authors: December 2013. Emailed trial author to request information about missing data but received no response. Not possible to use data from this trial
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not stated
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Double‐blind
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Double‐blind
Incomplete outcome data (attrition bias)
All outcomes Low risk No
Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no
Selective reporting (reporting bias) Low risk No indication of selective reporting