Van Bellinghen 2001.

Methods	Double‐blind randomised controlled trial of risperidone and placebo
Participants	Setting: residential care Sample size: 13; 6 active treatment, 7 placebo Sex: 5 males and 8 females Age range: 6 to 18 years Mean age: active treatment 10.5 (range 6 to 14) years; placebo 11 (range 7 to 14) years IQ range: 45 to 85 Inclusion criteria: "Persistent behavioural disturbance" (hostility, aggressive behaviour, irritability, agitation, hyperactivity) symptoms. Primary psychiatric diagnoses were not specified. Comorbidity: ADHD comorbidity not reported other that 1 participant in placebo group was on ritalin but this was discontinued during the trial; and 1 (in the active group) received concurrent antiepileptic (valproate) Withdrawn/dropouts: no withdrawals Other interventions: no description of pre‐existing or comorbid psychosocial interventions
Interventions	Intended dose: once daily, evenings, week 1 0.01 to 0.04 mg/kg/day, week 2 to 4 flexible dosing Mean dose at endpoint: 0.05 mg/kg (range 0.03 to 0.06 mg/kg or 1.2 mg/day)
Outcomes	Primary outcome: no pre‐specified primary endpoint (from email correspondence) Secondary outcomes: Aberrant Behaviour Checklist, Personal Assessment Checklist, Clinical Global Impression, visual analogue scale for the most disturbing symptom Follow‐up interval: 4 weeks
Notes	Imputation method for incomplete data: LOCF (page 7) Funding/support: "Support for this work was received from Janssen Pharmaceutica, Berchem, Belgium" (p 5)
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	Not stated.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated.
Incomplete outcome data (attrition bias) All outcomes	Low risk	"All patients completed the study" (p 7).
Selective reporting (reporting bias)	Unclear risk	Protocol unavailable.
Other bias	High risk	Pilot study, limited by a small sample size and thus limited power to detect differences. No SDs or SEs reported.

AACAP: American Academy of Child and Adolescent Psychiatry; ADHD: attention deficit hyperactivity disorder; DSM IV: Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; IQ: intelligence quotient; LOCF: last observation carried forward; PI: principal investigator; RCT: randomised controlled trial; SD: standard deviation; SE: standard error.