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. Author manuscript; available in PMC: 2014 Sep 19.
Published in final edited form as: Cochrane Database Syst Rev. 2011 Jan 19;(1):CD006626. doi: 10.1002/14651858.CD006626.pub2
Methods Allocation: random, computer-generated randomisation.
Blindness: double, double-dummy design.
Duration: 30 weeks.
Design: parallel.
Location: multicentre.
Participants Diagnosis: (DSM-IV) schizophrenia, schizoaffective disorder or schizophreniform disorder, BPRS total score of 36 or more.
N = 65.
Sex: 38 M, 27 F.
Age: 18 years or more (mean olanzapine = 35.6 years, mean risperidone = 34.8 years).
History: duration ill not reported, age at onset not reported.
Setting: in- and outpatient.
Interventions
  1. Olanzapine: flexible dose. Allowed dose range: 10-20 mg/day. Mean dose: 17.2 mg/day. N = 32.

  2. Risperidone: flexible dose. Allowed dose range: 4-8 mg/day. Mean dose: 6.6 mg/day. N = 33

Outcomes Leaving the study early: any reason, inefficacy.
Global State: CGI-S.
Mental State: PANSS total score, BPRS total score, PANSS positive subscore, PANSS negative subscore.
Quality of life: QLS, SF-36.
Adverse effects: open interviews, death (suicide attempt), cardiac effects (ECG), EPS (akathisia, dyskinesia, parkinsonism, rigor, tremor, use of antiparkinson medication), prolactin associated side effects (abnormal ejaculation, decreased libido, gynaecomastia, impotence), sedation, weight change, laboratory (glucose, leukopenia).
Unable to use:
Cardiac effects (no data).
Notes
Risk of bias
Bias Authors’ judgement Support for judgement
Adequate sequence generation? Low risk Random, computer-generated randomisation.
Allocation concealment? Unclear risk No further details.
Blinding?
subjective outcomes
Unclear risk Double, double-dummy design. Whether blinding was successful has not been examined, but the compounds differ quite substantially in side effects. This can be a problem for blinding
Blinding?
objective outcomes
Low risk Objective outcomes such as laboratory measures or death are unlikely to have been much affected by problems of blinding
Incomplete outcome data addressed?
All outcomes
High risk The overall attrition was high (55.4%). The LOCF method was used to account for people leaving the study early. It assumes that a participant who discontinued the study would not have had a change of his condition if he had remained in the study. This assumption can obviously be wrong
Free of selective reporting? High risk Only those adverse events that occurred in at least 10% of the participants were reported. This procedure can miss rare, but important adverse events
Free of other bias? High risk The study was sponsored by the manufacturer of olanzapine.