Methods | Allocation: two step randomisation before and after the availability of ziprasidone. Blinding: double, identical capsules. Duration: 26 weeks. Design: parallel. Location: not reported. |
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Participants | Diagnosis: (DSM-IV) chronic schizophrenia. N=444. Age: 18-65 years (mean olanzapine=40.0 years, mean quetiapine=40.1 years, mean risperidone=41.8 years, mean ziprasidone=41.3 years). Gender: 308 M, 136 F. History: duration of illness 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. Death: suicide. Adverse effects: open interviews, 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 |
Random sequence generation (selection bias) | Unclear risk | Random, 2 step randomisation before and after the availability of ziprasidone, Participants were re-randomised to a different medication than they had received in previous phase 1 |
Allocation concealment (selection bias) | Unclear risk | No further details. |
Blinding (performance bias and detection bias) 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 (performance bias and detection bias) 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 (attrition bias) All outcomes |
High risk | The attrition rate was extremely high (72. 5%). Efficacy data analysis was based on mixed models, but it is unclear whether any statistical method can account for such high dropout rates |
Selective reporting (reporting bias) | High risk | Use of antiparkinson medication was permitted but data on this was not available |
Other bias | Unclear risk | Patients had a history of intolerance to atypical antipsychotic treatment but baseline data on this were not provided |