Methods | Allocation: random, computer-generated randomisation. Blindness: double, double-dummy design. Duration: 30 weeks. Design: parallel. Location: multicentre. |
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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. |
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Interventions |
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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). |
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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. |