NCT00183339.

Study characteristics
Methods	12‐month parallel trial of fluoxetine versus placebo
Participants	Inclusion criteria: diagnosis of autism Exclusion criteria: diagnosis of Asperger's Syndrome, Rett Syndrome, Childhood Disintegrative Disorder, or PDDNOS' if SSRIs are not medically advisable, taking ongoing medications (except for diphenhydramine, clonidine, or melatonin for sleep) use of stimulants within the 5 days prior to enrolment recent use of psychotropic medications in the 14 days prior to commencing the trial recent commencement of behavioural, dietary or other treatment for autism in the month prior to commencing the trial Location/setting: details not provided on clinical registry Sample size: 18 Number of withdrawals/dropouts: 4/8; 6/10 (reasons not provided) Mean age: 44 months Gender: details not provided IQ: details not provided Baseline ABC‐I or other BoC: baseline ABC‐I not provided Concomitant medications: details not provided History of previous medications: details not provided
Interventions	Fluoxetine: "between 2 mg per day and 20 mg per day of liquid fluoxetine will be given in the morning using a flexible dosing strategy, following a 36‐week dose titration schedule" Placebo: "between 0.5ml per day and 5ml per day of liquid placebo will be given in the morning using a flexible dosing strategy, following a 36‐week dose titration schedule"
Outcomes	Primary outcomes: irritability, measured using the ABC‐I subscale (Aman 1985) AEs Secondary outcomes: tolerability
Notes	Study start date: September 2005 Study end date: March 2014 Funding: details not provided Conflicts of interest: details not provided
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 apart from, "Masking: quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)"
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Details not provided apart from, "Masking: quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)"
Incomplete outcome data (attrition bias) All outcomes	High risk	This study primarily aimed to look at rate of attrition and recruitment but doesn't provide data on reason for dropout.
Selective reporting (reporting bias)	Unclear risk	Primary outcome is rate of recruitment however without a protocol we can't be sure.
Other bias	Unclear risk	Paper has not been published as yet, so greater details have not been provided.