Ghaleiha 2014.

Study characteristics
Methods	Parallel trial of galantamine + risperidone versus placebo + risperidone
Participants	Inclusion criteria: outpatients aged 4‐12 years met the criteria for diagnosis of autism (DSM‐4‐TR) (≥ 6 symptoms, as per DSM 4‐TR) score of ≥ 12 on the ABC‐I Exclusion criteria: any other diagnosis of a psychiatric disorder on the DSM‐IV axis I or II, based on a structured diagnostic interview. severe intellectual disability any unstable medical illness, hepatic disease, active epilepsy, genetic syndrome or other clinically significant abnormality history of tardive dyskinesia or previous hypersensitivity with the use of galantamine or risperidone use of psychotropic medication in the 6 weeks prior to enrolment in the stud Location/setting: psychiatric academic hospital affiliated with Tehran University of Medical Sciences Sample size: galantamine 25; placebo 23 Number of withdrawals/dropouts: galantamine (5) because of withdrawn consent; placebo (3) because of withdrawn consent Gender: galantamine 17/20 male; placebo 18/20 male Mean age: galantamine 6.85 years; placebo 5.9 years IQ: galantamine 6 had mild intellectual disability, 2 had moderate intellectual disability; placebo 5 had mild intellectual disability, 4 had moderate intellectual disability Baseline ABC‐I or other BoC: ABC‐I baseline of ≥ 12 Concurrent medications: none permitted History of previous medications: galantamine 1 had taken valproic acid; placebo 1 sodium valproate, 1 carbamazepine, 1 vigabatrin, 1 phenobarbital
Interventions	Intervention (galantamine + risperidone) for 10 weeks: the initial dosage of galantamine was 2 mg/day and increased weekly in increments of 2 mg if tolerated and clinically indicated. The maximum dose was 12 mg/day for children weighing < 20 kg, 16 mg/day for children weighing 20–30 kg, 20 mg/day for children weighting 30–40 kg and 24 mg/day for children weighing ≥ 40 kg. Risperidone: titrated up to 1 mg/day for children weighing < 20 kg, and 2 mg/day for children weighing ≥ 20 kg Comparator (placebo + risperidone) for 10 weeks: risperidone was titrated up to 1 mg/day for children weighing < 20 kg, and 2 mg/day for children weighing ≥ 20 kg. The equivalent placebo was also administered.
Outcomes	Primary outcomes: irritability, measured using the ABC‐I (Aman 1985) response (partial or complete defined as a minimum 25% reduction and a minimum 50% reduction in ABC‐Irritability scores from baseline respectively) AEs Secondary outcomes: tolerability Timing of outcome assessments: baseline, week 5, week 10
Notes	Study start date: April 2012 Study end date: January 2013 Source of funding: Tehran University of Medical Sciences (grant number 13216 to SA) Conflicts of interest: none declared Trial registry: IRCT201204081556N40
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "randomization codes were generated by excel software by an independent person who was not involved elsewhere in the research project"
Allocation concealment (selection bias)	Low risk	Quote: "assignments were kept in sequentially‐numbered, sealed, opaque envelopes and were opened sequentially, only after the participant details were written on the envelope"
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "the patients, their parents and the physicians who referred them were all blind to the treatment assignments, so were the research investigators and the person who administered the medications. Placebo capsules and their ingredients were made to be identical to galantamine capsules"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The research investigators were blinded to the treatment assignments. Separate people were responsible for rating and random allocation of the patients.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Data analysed for 20 participants completing in each group
Selective reporting (reporting bias)	Low risk	All ABC domains reported
Other bias	High risk	The contact author is also on the ethics committee at the university funding the study. The contact author is a peer‐reviewer for one of the journals in which some of their studies are published.