Hollander 2012.

Study characteristics
Methods	Parallel trial of fluoxetine versus placebo
Participants	Inclusion criteria: people between the ages of 18 and 60 years met the DSM‐4 criteria for an ASD CGI score of ≥ 4 medication‐free status Exclusion criteria: history of hypersensitivity or side effects while receiving fluoxetine treatment abnormal electrocardiogram, laboratory test, or physical examination findings schizophrenia, schizoaffective disorder, bipolar disorder, active seizure disorder, or significant hematopoietic or cardiovascular disease Location/setting: details not provided Sample size: 37 (fluoxetine 22, placebo 15) Number of withdrawals/dropouts: 2 dropouts did not comply with study procedures, 1 discontinued because of relocation, and 1 discontinued because of poor tolerability Gender: 26 male, 11 female Mean age: 34.31 years IQ: 103.25 Baseline ABC‐I or other BoC: not applicable Concomitant medications: 0% History of previous medications: not reported
Interventions	Intervention (fluoxetine) for 12 weeks: dosage followed a fixed schedule, starting at 10 mg/day and increasing, as tolerated, up to 80 mg/day; mean final dose 9.9 mg/day Comparator (placebo) for 12 weeks: equivalent placebo
Outcomes	Primary outcomes: AEs irritability, measured using the ABC‐I subscale (although not reported) (Aman 1985) Secondary outcomes: none reported Timing of outcome assessments: AEs were measured biweekly
Notes	Study start date: not reported Study end date: not reported Source of funding: "funded by Food and Drug Administration orphan product g rant FD‐R‐0 0 2 0 2 6 ‐0 1 and supported by Studies to Advance Autism Research and Treatment (STAART) Center of Excellence grant 1U5 4 MH‐ 0 6 6 6 7 3 from NIMH, by the Seaver Foundation, and by the Mount Sinai General Clinical Research Center. Mount Sinai School of Medicine licensed an orphan designation for fluoxetine in autism to Neuropharm, Ltd". Conflicts of interest: "Dr Hollander has been a consultant to Abbott, Forest, and Neuropharm in the past. Dr Anagnostou has consulted without fees to Neuropharm, Novartis, and Proximagen. The other authors report no financial relationships with commercial interests". Trial registry ‐ NCT00004486
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	Unclear risk	Not described
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Loss to follow‐up by group not reported for all outcomes
Selective reporting (reporting bias)	High risk	ABC irritability data not reported
Other bias	High risk	Higher proportion of men (80%) in placebo group compared to fluoxetine group (64%); higher proportion who were white (86%) in the fluoxetine group compared to placebo group (53%); higher proportion had Asperger's (rather than ASD) (73%) in the fluoxetine group compared to placebo group (53%). No other differences in age, IQ, and baseline scores