Auchus 1997.

Study characteristics
Methods	Study design: randomised controlled trial Study grouping: parallel group Study duration: 6 weeks Rescue medication: no information provided
Participants	Number randomised: 12 (6 haloperidol 6 placebo) Mean age: 75.6 years Sex (female): 66% Type of dementia: Alzheimer's disease Severity of dementia: moderate Indication: Agitation (baseline CMAI 35.9) Setting: community‐dwelling Country: USA
Interventions	Intervention characteristics Haloperidol dosage: fixed 3 mg daily Placebo
Outcomes	Agitation: Cohen‐Mansfield Agitation Inventory (CMAI) Death Discontinuation due to adverse events Discontinuation (any reason) Carer burden or carer quality of life: Caregiver Strain Index (CSI)
Identification
Notes	Sponsorship source: Grant from Emory University Research Council (226‐93) and Grant Alzheimer’s Disease Core Center from the National Institute on Aging (P3OAG1O13O)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Insufficient information
Comparability of groups (selection bias)	Unclear risk	Baseline characteristics are not presented per group for all randomized. Baseline outcome score differ greatly but direction of bias unclear. Unclear whether the difference has been adjusted for.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	"double blind", but it is not described if haloperidol and placebo tablets did look the same and no other actions to secure blinding of personnel and participants are described. Patients probably blinded but unclear if blinding of personnel was performed.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information
Incomplete outcome data (attrition bias) All outcomes	High risk	High rate of drop‐out: 2/6 haloperidol (33%) and 1/6 (17%) placebo treated patients drop‐out.
Selective reporting (reporting bias)	Low risk	All outcomes reported in methods section are reported in the results section.
Other bias	High risk	Subjects in each group completed a 2‐week washout period during which any current psychotropic medications were carefully withdrawn.