Methods | Allocation: random, no further details. Blindness: double, no further details. Duration: 18 weeks. Design: parallel. Location: not reported. |
|
Participants | Diagnosis: schizophrenia, non-response to or intolerance of three previous antipsychotic treatment trials. N=146. Age: mean clozapine=38.3 years, mean ziprasidone=41.6 years. Gender: 101 M, 45 F. History: duration of illness not reported, age at onset not reported. Setting: not reported. |
|
Interventions |
|
|
Outcomes | Leaving the study early: any reason. Global State: CGI. Mental State: PANSS total score, PANSS positive subscore, PANSS negative subscore, depression Calgary depression scale for schizophrenia. Adverse effects: cardiac effects (ECG), laboratory. Unable to use- PANSS positive, negative subscore (no data). CGI (no data). Laboratory parameters (no usable data). |
|
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random, no further details. |
Allocation concealment (selection bias) | Unclear risk | No further details. |
Blinding (performance bias and detection bias) 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 (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 overall attrition was 38.4%. Data on reasons for dropout were not available. The last observation carried forward method was used to account for people leaving the study early |
Selective reporting (reporting bias) | High risk | Data were only presented as an abstract. Primary and secondary outcome data were reported incompletely |
Other bias | High risk | The study was sponsored by the manufacturers of ziprasidone. |