Schneider 2003 RIS USA 63.

Study characteristics
Methods	Study design: randomised controlled trial Study grouping: parallel group Study duration: 12 weeks Rescue medication: allowed Country: USA
Participants	Number randomised: 463 (of 625 in main trial) Mean age: 83.3 years Sex (female): 72% Type of dementia: Alzheimer's disease, vascular dementia, mixed type dementia Severity of dementia: severe Indication: mixed for main trial, but results were reported for the subgroup with psychosis at baseline. Setting: nursing home or chronic disease hospital
Interventions	Intervention characteristics Risperidone dosage: 2x0.5 mg, 2x1.0 mg or 2x2.0 mg daily Placebo
Outcomes	Psychosis: Behavioural Pathology in Alzheimer's Disease (BEHAVE‐AD) psychosis subscale
Identification
Notes	Sponsorship source: Janssen Research Foundation
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information for subgroup cohort
Allocation concealment (selection bias)	Unclear risk	No information for subgroup cohort
Comparability of groups (selection bias)	Unclear risk	No information for subgroup cohort
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Identically appearing risperidone (0.25, 0.5, and 1.0 mg) and placebo tablets were supplied by the sponsor. Each patient received 2 tablets twice daily. All trial drugs were appropriately labelled with a 2‐part la‐ bel containing the visit, protocol, patient numbers, and directions for administration. The first part of the label remained attached to the medication carton and the second part (double‐blind portion) was detached and placed in the case report form.Only says double blind but doesn't mention the persons who were blinded.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information if trained raters were blinded.
Incomplete outcome data (attrition bias) All outcomes	High risk	Modified (all patients who received at least one dose and one post baseline assessment) ITT analysis performed. Imputation LOCF. Discontinuation rates imbalanced across groups (range from 27% in the placebo group to 42% in the group receiving 2mg risperidone).
Selective reporting (reporting bias)	High risk	This is a secondary report of the trial based on the patients with psychosis only. Primary results are presented for the 1.0 and 2.0 group combined. Unclear why. Many outcomes that were reported in the main results paper based on all participants were not reported here.
Other bias	High risk	After a single‐blind placebo washout period of 3 to 7 days, eligible patients were randomly assigned to placebo or to 0.5, 1.0, or 2.0 mg/day of risperidone