Kaplan 1990.

Study characteristics
Methods	3 open trials, then a placebo‐controlled, double‐blind, cross‐over trial with 2 interventions: MPH placebo
Participants	Number of participants screened: 6. Number of participants followed up: 6 (all boys) Number of withdrawals: 0. 3 outpatients were studied in an open‐label design Diagnosis of ADHD: DSM‐III (subtype not stated) Age: mean 14.4 years (range 13‐16) IQ: mean 86 (range 76‐97) MPH‐naive: 5 (55%) Ethnicity: not stated Country: USA Setting: outpatient clinic and inpatient ward Comorbidity: aggressive CD (100%) Comedication: yes; diphenhydramine 50 mg Other sociodemographics: none Inclusion criteria Meeting DSM‐III criteria for both ADHD and aggressive CD Exclusion criteria Consent from parent or custodial social service agency Psychosis or drug abuse history
Interventions	Participants were randomly assigned to 1 of 2 possible drug condition orders of 0.6 mg/kg, with 30 mg as a ceiling for MPH and placebo Administration schedule: twice/d, 8:00 am and noon Mean MPH dosage: 0.47 mg/kg Duration of each medication condition: 3 weeks Washout before trial initiation: 1 week Medication‐free period between interventions: 20 h Titration period: 1 week after randomisation Treatment compliance: not stated
Outcomes	ADHD symptoms CTRS: completed weekly by classroom teachers In addition, for inpatients, CRS was completed weekly by the unit nurse Non‐serious AEs Treatment Emergent Side Effect Scale: completed weekly by treating psychiatrists Dizziness, appetite loss and headache were reported in 3 of the 9 youngsters
Notes	Sample calculation: no Ethics approval: no information Comment from trial authors As the result of an oversight, assignment to MPH‐first or placebo‐first condition was made in the absence of a specific randomisation formula. 5 of the 6 participants received placebo for the first condition and MPH for the second condition Key conclusion of trial authors Findings provide preliminary evidence of the efficacy of MPH in reducing aggression among aggressive conduct‐disordered adolescents also diagnosed with ADHD Inclusion of MPH responders only/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 declared Email correspondence with trial authors: March 2014. Emailed trial author twice to request additional information but have not received a reply.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	As the result of an oversight, assignment to MPH or placebo as the first condition was made in the absence of a specific randomisation formula. 5 of the 6 participants received placebo for the first condition and MPH for the second condition
Allocation concealment (selection bias)	Low risk	Assignment to order condition was determined with no knowledge of the particular participants involved; thus participants did not receive 1 condition or the other based on symptoms or any other systematic bias
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No information
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	In 2 cases, school vacation at the inpatient setting prevented teacher ratings from being obtained during 1 condition of the trial. In those 2 instances, the decision was made to use Conners' ratings obtained from the unit nurse for both the condition for which no teacher ratings were provided and the condition for which teacher ratings were given; thus comparisons were consistent in terms of rater. Selection bias (e.g. titration after randomisation → exclusion): no
Selective reporting (reporting bias)	Unclear risk	No protocol identified