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. Author manuscript; available in PMC: 2014 Sep 19.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Mar 17;(3):CD006654. doi: 10.1002/14651858.CD006654.pub2
Methods Allocation: random, no further details.
Blindness: double, no further details.
Duration: 8 weeks.
Design: parallel.
Location: single centre.
Country: Italy.
Participants Diagnosis: (DSM-IV) schizophrenia, treatment resistance to two previous antipsychotic medications, BPRS score of 27 or more.
N=23.
Age: 18 years or more (mean clozapine=38.3 years, mean olanzapine=34.1 years) (of completer population).
Sex: 16 M, 7 F.
History: duration ill not reported, age at onset not reported.
Setting: inpatient.
Interventions
  1. Clozapine: flexible dose. Allowed dose range: 300-400 mg/day. Mean dose: 325.4 mg/day. N=12.

  2. Olanzapine: flexible dose. Allowed dose range: 15-20 mg/day. Mean dose: 18.3 mg/day. N=11

Outcomes Leaving the study early: any reason, adverse events, inefficacy.
Mental State: PANSS total score, BPRS total score, PANSS positive subscore, PANSS negative subscore.
Receptor occupancy measures ([18F]FESP/PET).
Adverse effects: open interviews, EPS (SAS, AIMS).
Unable to use -
AIMS (no useable data).
Notes
Risk of bias
Bias Authors’ judgement Support for judgement
Adequate sequence generation? Unclear risk Random, no further details.
Allocation concealment? Unclear risk No further details.
Blinding?
Objective outcomes
Low risk Objective outcomes such as laboratory measures or death are unlikely to have been much affected by problems of blinding
Blinding?
Subjective outcomes
Unclear risk Double, no further details. Whether blinding was successful has not been examined, but the compounds differ quite substantially in side-effects. This can be a problem for blinding
Incomplete outcome data addressed?
All outcomes
High risk Numbers of leaving the study early were high (34.8%). The statistical analysis was based on completer data
Free of selective reporting? High risk Data on EPS scales were incompletely reported.
Free of other bias? High risk The study was sponsored by the manufacturer of olanzapine.