NCT00198107.

Study characteristics
Methods	48‐week parallel trial of aripiprazole versus placebo
Participants	Inclusion criteria: aged 5‐17 years weight ≥ 15 kg meet the DSM‐4 criteria for autism free of psychotropic medications for at least 2 weeks prior to baseline ABC‐I of at least 18 at baseline CGI‐S score of at least 4 mental age of at least 18 months Exclusion criteria: Asperger's syndrome, Rett's disorder, childhood disintegrative disorder, Fragile X, tuberous sclerosis, any other PDD, schizophrenia, psychotic disorder, or bipolar disorder any other significant medical condition such as heart, kidney, liver or lung disease, or seizure disorders pregnant previous treatment with aripiprazole or hypersensitivity to aripiprazole Location/setting: USA (Riley Hospital for Children, Christian Sarkine Autism Treatment Center, Indiana University School of Medicine) Sample size: 81 randomised, 40 aripiprazole, 41 placebo Mean IQ: details not provided Mean age: details not provided Gender: 4/38 female in aripiprazole group, 7/40 female in placebo group Reasons for dropouts: 6 from placebo group discontinued, AE (1), lack of efficacy (2), LTFU (2), doctor decision (1); 3 from aripiprazole group discontinued, AE (1), LTFU (1), withdrawal by participant (1) Baseline ABC‐I or other BoC scale: details not provided Concomitant medications: details not provided Previous medications: details not provided
Interventions	Intervention (aripiprazole) for 8 weeks: participants ≤ 49 kg will receive maximum dose of 10 mg/day of aripiprazole over 8 weeks. Participants weighing ≥ 50 kg will receive a maximum dose of 15 mg/day aripiprazole over 8 weeks. Comparator (placebo) for 8 weeks: matching placebo pill for 8 weeks
Outcomes	Primary outcomes: ABC‐Irritability (Aman 1985) AEs Secondary outcomes: tolerability Timing of outcome assessments: ABC‐I measured in weeks 1, 2, 3, 4, 6, and 8 (endpoint)
Notes	Study start date: September 2005 Study end date: April 2019 Funding: details not provided Conflicts of interest: details not provided
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	Only details provided were on the trials registry, "Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)"
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Only details provided were on the trials registry, "Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)"
Incomplete outcome data (attrition bias) All outcomes	Low risk	Dropout < 15%, reasons reported
Selective reporting (reporting bias)	Unclear risk	No information
Other bias	Unclear risk	Not stated