Mintzer 2007.

Study characteristics
Methods	Study design: randomised controlled trial Study grouping: parallel group Study duration: 10 weeks Rescue medication: allowed for NPS and EPS
Participants	Number randomised: 487 (366 aripiprazole, 121 placebo) Mean age: 82.5 years Sex (female): 79% Type of dementia: Alzheimer's disease Severity of dementia: moderate Indication: Psychosis (baseline NPI‐NH psychosis: 11.6) Setting: nursing homes or residential assisted‐living facilities Country: USA, Australia, Canada, South Africa, and Argentina
Interventions	Intervention characteristics Aripiprazole dosage: fixed 2 mg/day, 5 mg/day, or 10 mg/day Placebo Nodose modification of study medication was allowed for tolerability reasons after titration during the acute phase. Patients unable to tolerate acute‐phase study medication were discontinued from the study.
Outcomes	Psychosis: Neuropsychiatric Inventory–Nursing Home version (NPI‐NH) psychosis subscale Number of responders for psychosis Extrapyramidal symptoms Somnolence Death Any serious adverse event Discontinuation (any reason) Discontinuation due to adverse events Cognitive function: Mini‐Mental State Examination (MMSE)
Identification
Notes	Sponsorship source: Alzheimer’s Research & Clinical Programs, Medical University of South Carolina and the Ralph H. Johnson VA Medical Center, Charleston, SC (JEM); the Department of Psychiatry, Emory University, Atlanta, GA (LET); Bristol‐Myers Squibb Company, Wallingford, CT (CDB, RNM); Bristol‐Myers Squibb Company, Braine l’Alleud, Belgium (RS); and Otsuka Pharmaceutical Development & Commercialization, Princeton, NJ (RDM, AF).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information
Allocation concealment (selection bias)	Unclear risk	No information
Comparability of groups (selection bias)	Unclear risk	No information
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No information
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information
Incomplete outcome data (attrition bias) All outcomes	High risk	Drop‐out was very high (42%). Modified ITT with exclusion of patients who did not take at least one dose of study medication, and did not have at least one postbaseline evaluation within 7 days after the last medication was taken. Handling of missing data with LOCF.
Selective reporting (reporting bias)	High risk	Outcome was measured with several scales and presented for each drug group separately. Subanalyses of individual NPI items. No correction for multiple testing. % any adverse event per group missing. No study protocol available.
Other bias	High risk	Concomitant use of antipsychotics, mood stabilizers or sedatives (except trazodone [25–50 mg], zolpidem tartrate [2.5–5.0 mg] and temazepam [7.5–15.0 mg]) was prohibited during the study treatment period and the seven days prior to randomization.