Streim 2008.

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: 256 (131 aripiprazole125 placebo) Mean age: 83.0 years Sex (female): 76% Type of dementia: Alzheimer's disease Severity of dementia: moderate Indication: psychosis (Psychosis NPI‐NH: 10.6) Setting: institutionalised persons (i.e. residing in a nursing home or residential assisted‐living facility) Country: USA
Interventions	Intervention characteristics Aripiprazole dosage: flexible, 2 mg to 15 mg/ day Placebo Aripiprazole dosing was flexible, starting at 2 mg/day, with titration to higher doses (5 mg, 10 mg, and 15 mg/day) depending on the study physicians’ clinical judgment. The recommended titration schedule was 2 mg/day for 1 week, increasing to 5 mg/day for 2 weeks, 10 mg/day for the next 2 weeks, and 15 mg/day for the remainder of the acute phase (Weeks 6 –10). The mean daily aripiprazole dose at Week 10 was 9.0 mg (range: 0.7 mg to 15.0 mg).
Outcomes	Psychosis: Neuropsychiatric Inventory–Nursing Home version (NPI‐NH) psychosis score Number of responders for psychosis Extrapyramidal symptoms Somnolence Death Any adverse event Any serious adverse event Discontinuation (any reason) Discontinuation due to adverse events Cognitive function: Mini‐Mental State Examination (MMSE) Functioning in activities of daily living: Alzheimer’s Disease Cooperative Study – Activities of Daily Living for Severe impairment (ADCS‐ADL‐SEV)
Identification
Notes	Sponsorship source: Bristol‐Myers Squibb Company, Wallingford, CT (CDB, Marcus); Bristol‐Myers Squibb Company, Braine l’Alleud, Belgium (RS); Otsuka America Pharmaceutical Inc., Princeton, NJ (McQuade, WHC)
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	Limited set of relevant baseline characteristics shown. Small differences in set shown. Outcome score at baseline is not given for all randomized, but adjusted for in the analyses.
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 high (41%). Modified ITT was used excluding patients that did not receive one dose of study medication or an assessment after baseline (within 7 days after taking medication). Missing data was imputed with LOCF.
Selective reporting (reporting bias)	Unclear risk	Insufficient information. Study protocol is available but no outcomes prespecified. Two coprimary outcomes. Multiple scales for NPS. Many additional analyses including OC comparisons. Unusual cut‐offs f.i. only weight increase of 7% or more included. Correction for multiple testing.
Other bias	High risk	Following screening and a minimum 7‐day psychotropic medication washout period (...)