Methods | Allocation: random, 2 steps of randomisation before and after availability of ziprasidone, subjects received other medication than in previous phase 1 treatment. Re-randomised. Blindness: double, identical capsules. Duration: 26 weeks. Design: parallel. Location: not reported. |
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Participants | Diagnosis: (DSM-IV) chronic schizophrenia. N = 444. Sex: 308 M, 136 F. Age: 18-65 years (mean olanzapine = 40.0 years, mean quetiapine = 40.1 years, mean risperidone = 41.8 years, mean ziprasidone = 41.3 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, adverse events, inefficacy. Global State: CGI. Mental State: PANSS total score. Adverse effects: open interviews, death (suicide), EPS (akathisia), cardiac effects (ECG), prolactin-associated side effects, weight gain, laboratory (prolactin, glucose, cholesterol) |
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Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Random, 2 steps of randomisation before and after availability of ziprasidone, subjects received other medication than in previous phase 1 treatment. Re-randomised |
Allocation concealment? | Unclear risk | No further details. |
Blinding? subjective outcomes |
Unclear risk | Double, identical capsules. Whether blinding was successful has not been examined, but both 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 (72.5%). The main statistical analysis used a mixed effects model approach. It is unclear whether any statistical method can account for such high rates of leaving the study early |
Free of selective reporting? | High risk | Use of antiparkinson medication was permitted but data on this outcome have not been presented |
Free of other bias? | Unclear risk | Patients had a history of former intolerance to atypical antipsychotic treatment but baseline data on this was not provided |