Ghanizadeh 2014.

Study characteristics
Methods	Parallel trial of aripiprazole versus risperidone
Participants	Inclusion criteria: children and adolescents with ASD (diagnosed according to DSM‐4‐TR and according to ADI‐R. clinician rating of at least moderate severity of autistic symptoms (CGI‐S score of C4, range 0‐7) Exclusion criteria: history of medically significant or uncontrolled medical conditions such as hypothyroidism, diabetes or cancer history of drug or alcohol abuse received risperidone or aripiprazole during the last 2 weeks prior to enrolment in the study received any additional behavioural intervention Location/setting: child psychiatry outpatient clinic affiliated with Shiraz University of Medical Sciences, Iran Sample size: 59 were randomised (29 aripiprazole, 30 risperidone) Number of withdrawals/dropouts: 3 children dropped out of aripiprazole group because of severity of symptoms (1), exacerbation of epilepsy (1) and severe sedation (1). 3 children dropped out of the risperidone group due to lack of efficacy (1), refused to return (1), agitation and crying (1) Gender: aripiprazole 25/29 male; risperidone 23/30 male Mean age: aripiprazole 9.6 years, risperidone 9.5 years IQ: not reported Baseline ABC‐I or other BoC: ABC‐I aripiprazole 26.2; risperidone 21.5 Concomitant medications: concurrent medications were allowed apart from antipsychotics provided they were stable throughout the trial and commenced at least two weeks prior to the trial. History of previous medications: details not provided
Interventions	Intervention (aripiprazole) for 8 weeks: maximum dose of aripiprazole for children weighing < 40 kg was up to 10 mg/day and up to 15 mg/day for children > 40 kg. The dose of aripiprazole was titrated over 2 weeks (1.25 mg/day starting dose); mean daily dose of 5.5 mg/day (approximately 0.163 mg/kg/day) Comparator (risperidone) for 8 weeks: maximum dose for children weighing < 40 kg was 2 mg, and for those > 40 kg was up to 3 mg/day. Risperidone was titrated over 2 weeks (0.25 mg starting dose); risperidone mean daily dose 1.12 mg/day (or 0.033 mg/kg/day)
Outcomes	Primary outcomes: irritability, measured using the ABC‐I subscale (Aman 1985) AEs Secondary outcomes: none reported Timing of outcome assessments: baseline, 1 month and 2 months (endpoint)
Notes	Study start date: not reported Study end date: not reported Source of funding: "grant (No: 3135) from Shiraz University of Medical Sciences to Professor Ahmad Ghanizadeh. MB is supported by the Simons Autism Foundation. MB has received Grant/Research Support from the NIH, Cooperative Research Centre, Simons Autism Foundation, Cancer Council of Victoria, Stanley Medical Research Foundation, MBF, NHMRC, Beyond Blue, Rotary Health, Geelong Medical Research Foundation, Bristol Myers Squibb, Eli Lilly, Glaxo SmithKline, Organon, Novartis, Mayne Pharma and Servier, has been a speaker for Astra Zeneca, Bristol Myers Squibb, Eli Lilly, Glaxo SmithKline, Janssen Cilag, Lundbeck, Merck, Pfizer, Sanofi Synthelabo, Servier, Solvay and Wyeth, and served as a consultant to Astra Zeneca, Bristol Myers Squibb, Eli Lilly, Glaxo SmithKline, Janssen Cilag, Lundbeck Merck and Servier, and is a co‐inventor of two provisional patents regarding the use of NAC and related compounds for psychiatric indications". Conflicts of interest: none declared Trial registry ‐ IRCT201110233930N15
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	The clinician who administered the medications was not blind to assignment and "about 7 of the parents (12%) of the parents were not blinded to the group assignment because they could correctly guess the group allocation or requested to be not blinded to it".
Blinding of outcome assessment (detection bias) All outcomes	High risk	Some parents knew of their allocation and contamination could have occurred.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants completed both the first and second follow‐up and an ITT analysis was used. LTFU aripiprazole: severity of symptoms (1); exacerbation of epilepsy (1); and severe sedation (1) LTFU risperidone: lack of efficacy (1); refused to return (1); agitation and crying (1)
Selective reporting (reporting bias)	High risk	The most common AEs associated with risperidone were not reported (sedation and weight gain)
Other bias	Low risk	None identified