Campbell 1987.

Study characteristics
Methods	Parallel trial of fenfluramine versus placebo
Participants	Inclusion criteria: children 2‐7 years met the DSM‐III criteria for infantile autism, full syndrome patients in Bellevue Hospital, Children's Psychiatric inpatient service free of psychoactive drugs for a minimum of 2 weeks prior to the study Exclusion criteria: "children who had a known cause of autism" Location/setting: children's psychiatric inpatient service, USA Sample size: 11 (6 fenfluramine, 5 placebo) Number of withdrawals/dropouts: none reported Gender: 9 male, 2 female Mean age: 4.48 (1.16) years IQ: "adaptive developmental quotients ranged from 34‐83” Baseline ABC‐I scores or other BoC: not reported/ applicable Concomitant medications: 0% History of previous medications: not reported
Interventions	Intervention (fenfluramine) for 8 weeks: fenfluramine was started at 1.0 mg/kg/day in 2 daily doses. The maximum dose would not exceed 60 mg/day Comparator (placebo) for 8 weeks: "for placebo, the optimal doses ranged from 1.8‐3.3 mg/kg/day (mean = 2.2); the maximum explored dose was 3.3 mg/kg/day.’
Outcomes	Primary outcomes: AEs Secondary outcomes: none reported Timing of outcome assessment: baseline, week 4, week 8
Notes	Study start date: not reported Study end date: not reported Funding source: supported, in part, by USPHS grant MH‐32212 from the National Institute of Mental Health Conflicts of interest: none 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	Details not provided
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Details not provided
Incomplete outcome data (attrition bias) All outcomes	Low risk	Low attrition
Selective reporting (reporting bias)	High risk	Only selected items from the CGI and CPRS were reported. "None of the items on the CPRS nor their sum produced a statistically significant interaction. The effects of fenfluramine were thus indistinguishable from those of placebo".
Other bias	Unclear risk	No group differences published