Methods | Allocation: random, no further details. Blindness: double, no further details. Duration: 52 weeks. Design: parallel. Location: multicentre. Countries: USA, Canada. |
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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. |
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Interventions |
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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) |
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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. |