Breier 2002.

Methods	Allocation: randomised. Blindness: double. Duration: 24 hours.
Participants	Diagnosis: schizophrenia, schizophreniform or schizoaffective disorder. N = 270. Age: range 18‐73 years. Sex: 155 males, 115 females. History: "recently hospitalised with acute agitation." Mean age at onset of illness 25.1 (SD 7.3) years. Excluded: people with "significant medical disorders, including alcohol and/or drug dependency, were excluded from this trial." Setting: Multi‐centre (Croatia, Italy, Romania and South Africa).
Interventions	1. Haloperidol IM: dose up to 3 injections of 7.5 mg/IM (mean number of IMs not reported, mean dose 9.9 mg (SD 4.6). N = 40. 2. Olanzapine IM: dose up to 3 injections of 2.5 mg/IM (mean number of IMs not reported, mean dose 4 mg (SD 1.5). N = 48. 3. Olanzapine IM: dose up to 3 injections of 5 mg/IM (mean number of IMs not reported, mean dose 6.9 mg (SD 2.7). N = 45. 4. Olanzapine IM: dose up to 3 injections of 7.5 mg/IM (mean number of IMs not reported, mean dose 9.8 mg (SD 3.8). N = 46. 5. Olanzapine IM: dose up to 3 injections of 10 mg/IM (mean number of IMs not reported, mean dose 12.6 mg (SD 4.9). N = 46*. 6. Placebo IM. N = 50. 2nd injection allowed 2 hours after 1st, 3rd injection allowed 4 hours after 2nd injection. Both to be administered within 20 hours of 1st injection. Need for subsequent doses at the discretion of the investigator.
Outcomes	Mental state: BPRS Total, BPRS Positive. Global state: CGI‐S, additional injections, need for benzodiazepine. Agitation: ABS, PANSS‐EC. Adverse events: QT interval at 24 hours, hypotension**, acute dystonia**, EPS**. Unable to use*** ‐ Leaving the study early: reasons are not given for why participants did not complete the study. Adverse effects: SAS (mean, SE/SD not reported). Adverse effects: BAS (mean, SE/SD not reported). Adverse effects: need for anticholinergic therapy (olanzapine 10 mg/IM not reported). Adverse effects: QT interval at 2 hours (mean, SE/SD not reported).
Notes	* For data analysis, where continuous outcomes were used, haloperidol was compared with Olanzapine 10 mg/IM as this is the dose referred to as usual by the BNF (BNF 2011). ** It is possible that this binary data was derived from the BAS scale. *** Additional data are reported by dose but not used in this review (Table 52; Table 53; Table 54; Table 55; Table 56)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Described as randomised ‐ method of randomisation is not reported.
Allocation concealment (selection bias)	Low risk	"Allocation concealed placebo‐controlled trial." Method of randomisation not reported.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"unblinded third‐party personnel, who played no role in evaluating patients, were trained to handle and administer injections in identical, unmarked syringes." "Investigators, patients, clinical carers and raters were blinded."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"Investigators, patients, clinical carers and raters were blinded."
Incomplete outcome data (attrition bias) All outcomes	High risk	Reasons why all participants that left the study early were not reported.
Selective reporting (reporting bias)	Unclear risk	It is not clear whether all side effects are reported.
Other bias	High risk	Trial sponsored by manufacturers of olanzapine IM.