Dollfus 1992.

Study characteristics
Methods	Cross‐over trial of amisulpride versus bromocriptine
Participants	Inclusion criteria: "children 4‐13 years inclusive who meet the DSM‐III diagnostic criteria for infantile autism. Severity of autism according to the Childhood Autism Rating Scale was at least 36 indicating 'severely autistic'." Exclusion criteria: details not provided Location/setting: inpatients and outpatients at Salpetriere hospital, Paris Sample size: 9 in total (cross‐over study). Amisulpride first group (5); bromocriptine first group (4) Number of withdrawals/dropouts: none in first phase of cross‐over. Only one dropped out of the study during the second treatment phase (amisulpride) on week 12 for reasons unrelated to the treatment Gender: 4 girls, 5 boys Mean age: 6.9 years IQ: "the severity of the autistic syndrome did not allow IQ tests to be given. It may be presumed, therefore, that the children are likely to have been severely mentally retarded". Baseline ABC‐I or other BoC: not an outcome Concurrent medications: "two of the nine children had received neuroleptic treatment at the time of selection. Therefore, a 45‐day neuroleptic washout period was required". No neuroleptic or other psychotropic drugs were allowed during the trial, except benzodiazepine, niaprazine, or hydroxyzine for severe sleep disorders, which 3 participants took concurrently during the trial (1 participant niaprazine; 1 participant niaprazine and flunitrazepam‐hydroxyzine; 1 participant hydroxyzine) History of previous medications: not reported
Interventions	Intervention (amisulpride): 1.5 mg/kg/day for 4 weeks Comparator (bromocriptine): 0.15‐0.20 mg/kg/day for 4 weeks
Outcomes	Primary outcomes: AEs Secondary outcomes: none reported Timing of outcome assessment: baseline and then every 2 weeks for 14 weeks
Notes	Study start date: not reported Study end date: not reported Source of funding: research protocol subsidised by MUSTELA Foundation (under the aegis of the Foundation of France) Conflicts of interest: none declared Trial registry: not reported
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	Double‐blinding was used although specific details not provided
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The raters were blind to the treatment"
Incomplete outcome data (attrition bias) All outcomes	Low risk	Only 9 participants were involved in the trial, with only 1 person withdrawing from the trial during the second phase of the crossover trial. A LOCF was used for the analysis of this participant.
Selective reporting (reporting bias)	Unclear risk	The BSE was reported fully at baseline and endpoint for both phases of the cross‐over, however the BSE is not relevant to the outcomes of interest. Non‐specific BSE measures include items on aggressiveness which not reported specifically, rather included as part of total score.
Other bias	Unclear risk	No other sources identified but difficult to know without a protocol or trial registry