Methods | Allocation: random, no further details. Blindness: double, no further details. Duration: 8 weeks. Design: parallel. Location: single centre. Country: Italy. |
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Participants | Diagnosis: (DSM-IV) schizophrenia, treatment resistance to two previous antipsychotic medications, BPRS score of 27 or more. N=23. Age: 18 years or more (mean clozapine=38.3 years, mean olanzapine=34.1 years) (of completer population). Sex: 16 M, 7 F. History: duration ill not reported, age at onset not reported. Setting: inpatient. |
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Interventions |
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Outcomes | Leaving the study early: any reason, adverse events, inefficacy. Mental State: PANSS total score, BPRS total score, PANSS positive subscore, PANSS negative subscore. Receptor occupancy measures ([18F]FESP/PET). Adverse effects: open interviews, EPS (SAS, AIMS). Unable to use - AIMS (no useable data). |
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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 | Numbers of leaving the study early were high (34.8%). The statistical analysis was based on completer data |
Free of selective reporting? | High risk | Data on EPS scales were incompletely reported. |
Free of other bias? | High risk | The study was sponsored by the manufacturer of olanzapine. |