Methods | Allocation: random, no further details. Blindness: double, no further details. Duration: 8 weeks. Design: parallel. Location: multicentre. |
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Participants | Diagnosis: (DSM-IV) schizophrenia (n = 149) or schizoaffective disorder (n = 26), PANSS between 50 and 120. N = 176. Sex: 62 M, 113 F (of intent-to-treat population). Age: 60 years or more (mean olanzapine = 71.4 years, mean risperidone = 70.9 years) (of intent-to-treat population). History: duration ill mean = 36.5 years, age at onset mean olanzapine = 33.4 years, mean risperidone = 36.0 years (of intent-to-treat population). 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: CGI. Mental State: PANSS total score, PANSS positive subscore, PANSS negative subscore. Adverse effects: open interviews, cardiac effects (ECG), death (natural causes, suicide) EPS (akinesia, dystonia, extrapyramidal symptoms, parkinsonism, tremor, use of antiparkinson medication, ESRS), sedation, seizures, weight change, laboratory (cholesterol, glucose, prolactin) |
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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? 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 |
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 |
Unclear risk | Number of participants leaving the study early was moderate (23.9%). 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. It is unclear whether this led to bias |
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 risperidone. The mean age of included subjects was about 71 years. Probably due to this reason the upper dose range limit of risperidone was rather low (3mg/day), compared to that of olanzapine (20mg/day) |