NCT00468130.

Study characteristics
Methods	8‐week parallel trial of aripiprazole versus placebo
Participants	Inclusion criteria: meets DSM‐4 for ASD is an outpatient 5‐17 years of age parents consent to participate in the trial Exclusion criteria: diagnosed with a psychotic disorder history of prior treatment of aripiprazole ≥ 5 mg/day history of diabetes significant medical conditions at risk of self‐injury pregnant or breastfeeding Setting/location: the USA Sample size: 15 in total Number and reason for dropouts: 2 in each group dropped out, 3 due to AEs and 1 withdrew Mean age: 12.4 years Gender: 2 female, 11 male Mean IQ: details not provided Previous or current medications: details not provided
Interventions	Intervention (aripiprazole): participants weighing < 40 kg will receive a maximum of 10 mg/day of aripiprazole, and a maximum of 20 mg/day for children ≥ 40 kg for 8 weeks Comparator (placebo): equivalent placebo (sugar pills) for 8 weeks
Outcomes	Primary outcomes: irritability, measured using the ABC‐I subscale (Aman 1985) AEs Secondary outcomes: none reported Timing of outcome assessments: every second week
Notes	Source of funding: University of Medicine and Dentistry of New Jersey Conflicts of interest: unclear
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Details not provided
Allocation concealment (selection bias)	Unclear risk	Details not provided
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Apart from, "Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)", no other details provided.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Apart from "Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)", no other details provided.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	8‐week data appear to be reported for all participants, but study authors note 2 dropouts due to AEs in treatment group (i.e. nearly 30% dropout). Unclear if outcome data are really complete.
Selective reporting (reporting bias)	Unclear risk	Protocol is available and all prespecified outcomes of interest reported in the prespecified way
Other bias	High risk	The baseline ABC‐I scores were twice that in the intervention group compared to placebo.