Kane 2003.

Methods	Allocation: randomised, method not described. Blindness: double (during treatment phase). Duration: 6 weeks, preceded by 2‐14 day patient screening, 2 day neuroleptic washout, 4‐6 weeks confirmation of treatment resistance, 2‐10 day neuroleptic washout. Design: multicentre, parallel. Setting: unknown. Consent: obtained. Loss: described.
Participants	Diagnosis: schizophrenia (DSM‐IV). N=300. Age: >18 years, mean˜42.1 years. Sex: male 208, female 92. History: treatment resistant during 2 years prior to study, PANSS total score of >/= 75 & score of >/= 4 on 2 or more specified PANSS items; CGI‐I score > 4, treated as out‐patient for at least 1 continuous 3‐month period during the 2 years prior to study entry. Exclusions: DSM IV diagnosis of schizoaffective disorder, residual schizophrenia or bipolar disorder; delirium, dementia, amnesia or other cognitive disorders; any acute or unstable medical condition; refractory to previous clozapine therapy; prior perphenazine treatment without adequate response; likelihood to require prohibited concomitant therapy during study; current or recent psychoactive drug or alcohol abuse or dependence; suicidal attempts or serious suicidal thoughts; known allergy or hypersensitivity to study drugs; treatment with an investigational drug within 4 weeks of the washout period; previous enrolment in an aripiprazole clinical study; pregnant or lactating women.
Interventions	1. Aripiprazole: dose 15‐30 mg/day, average dose 28.8 mg/day. N=154. 2. Perphenazine: dose 8‐64 mg/day, average dose 39.1 mg/day. N=146.
Outcomes	Global state: change in CGI‐S score, mean CGI‐I score; discontinuation due to adverse event including psychosis, lack of efficacy. Mental state: response, change in PANSS score, change in BPRS score. Adverse effects. Quality of life: QLS scores. Satisfaction with treatment: withdrawal of consent. Economic outcomes: concomitant medication. Leaving the study early. Death. Unable to use ‐ Adverse affects: mean change in AIMS, BAS, SAS (no usable data); mean change in prolactin levels and body weight (no SD); abnormalities of vital signs and laboratory findings (no usable data). Quality of life: mean change in QLS scores.
Notes	Limited data given on standard deviations. Data reported in both LOCF and OC analyses. Jadad=2.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear