Ghanizadeh 2015.

Study characteristics
Methods	Parallel trial of buspirone + risperidone versus placebo + risperidone
Participants	Inclusion criteria: children 4‐17 years DSM‐4 diagnosis of autism, a CGI‐Severity score of C4, range 0‐7 at baseline able to swallow medication if taking concomitant medications must maintain them at a constant dose during the study Exclusion criteria: primary diagnosis of a psychotic disorder active substance abuse or dependence unstable medical condition, active liver disease, an unstable hypertension or cardiac disease, unstable asthma, kidney disease as determined by the investigator allergic to medications initiation of a new behavioral therapy Location/setting: "child and adolescent psychiatry clinic affiliated with Shiraz University of Medical Sciences [Iran] clinics specializing in the treatment of child and adolescent psychiatry problems". Sample size: 40 (20 in each group) Number of withdrawals/dropouts: 16 completing trial in the busperone group; 18 in placebo group Gender: buspirone 12/16 boys, placebo 15/18 boys Mean age: buspirone 7.05 years, placebo 7.5 years IQ: not reported Baseline ABC‐I or other BoC: ABC‐I buspirone 25.7, placebo 24.7 Concomitant medications: not reported History of previous medications: not reported
Interventions	Intervention (buspirone + risperidone) for 8 weeks: buspirone was titrated to a maximum 10 mg/day given twice daily for children weighing < 40 kg, and up to 20 mg/day for children weighing > 40 kg. The dose of risperidone was up to 2 mg/day for children weighing < 40 kg and up to 3 mg/day for children weighing > 40 kg. The dosage was increased to this target/maximum dose from week 1 to week 2, and modified at any time in response to clinical efficacy and AEs. Comparator (placebo + risperidone) for 8 weeks: the dose of risperidone was up to 2 mg/day for children weighing < 40 kg and up to 3 mg/day for children weighing > 40 kg. The dosage was increased to this target/maximum dose from week 1 to week 2, and modified at any time in response to clinical efficacy and AEs.
Outcomes	Primary outcomes: irritability, measured with the ABC (Aman 1985) response rate Secondary outcomes: tolerability Timing of outcome assessment: baseline, week 4, week 8
Notes	Study start date: 2012 Study end date: 2013 Source of funding: supported by a grant from Shiraz University of Medical Sciences to Professor Ahmad Ghanizadeh (grant no. 6978) Conflicts of interest: none declared Trial registry: IRCT201307303930N28
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "A random number list provided by a random number generator was used for the allocation of the patients into the groups".
Allocation concealment (selection bias)	Unclear risk	Quote: "both risperidone and placebo were administered in the form of similar tablets"
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Reported to be double‐blinded however, the "physician who interviewed the patients and allocated the patients into the groups was not blinded".
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The person who allocated the patients into the group and the person who rated the outcome measure were different.
Incomplete outcome data (attrition bias) All outcomes	High risk	Mentioned assessment at week 4 but these outcomes were not reported LTFU: 2 people did not respond to calls (1 in each group). 1 person's symptoms of crying and isolation were exacerbated (buspirone group)
Selective reporting (reporting bias)	High risk	The Iranian clinical trial registry does not include results (neither does the paper include week 4 measures) and the trial was retrospectively registered online.
Other bias	High risk	The study authors retrospectively registered the trial on the Iranian clinical trials website ‐ it is unknown whether 8 weeks was the original length of the trial or not.