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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: 52 weeks.
Design: parallel.
Location: multicentre.
Countries: USA, Canada.
Participants Diagnosis: (DSM-IV) schizophrenia or schizoaffective disorder.
N=414.
Age: 18-55 years (mean=39 years).
Sex: 282 M, 132 F.
History: duration ill not reported, age at onset not reported.
Setting: in- and outpatient.
Interventions
  1. Haloperidol: flexible dose. Allowed dose range: 2-19 mg/day. Mean dose: 8.2 mg/day. N=97.

  2. Olanzapine: flexible dose. Allowed dose range: 5-20 mg/day. Mean dose: 12.3 mg/day. N=159.

  3. Risperidone: flexible dose. Allowed dose range: 2-10 mg/day. Mean dose: 5.2 mg/day. N=158

Outcomes Leaving the study early: any reason, adverse events, inefficacy.
Global State: relapse.
Mental State: PANSS total score, PANSS positive subscore, PANSS negative subscore, depression (MADRS), anxiety (Hamilton anxiety scale).
Cognitive Functioning: Neurocognitive Composite Score.
Adverse effects: open interviews, EPS (akathisia, tremor, use of antiparkinson medication, AIMS, BAS, SAS), sedation, weight change, laboratory (cholesterol, prolactin, urine analysis)
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 The attrition rate was high (62.8%). The last-observation-carried-forward 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.