Methods | Allocation: random, no further details. Blindness: double, no further details. Duration: eight weeks. Design: parallel. Location: multicentre. |
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Participants | Diagnosis: (DSM-III-R) schizophrenia (n=260) or schizoaffective disorder (n=36), acute exacerbation, PANSS total score of ≥60. N=296. Age: 18-64 years. Gender: 215 M, 81 F. History: duration of illness not reported, age at onset mean risperidone=24.6 years, mean ziprasidone=25.2 years. Setting: not reported. |
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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 derived BPRS, BPRS positive subscore, PANSS negative subscore, depression MADRS. General functioning: GAF. Adverse effects: open interviews, EPS (akathisia, tremor, use of antiparkinson medication, AIMS, BAS, SAS), cardiac effects (ECG), prolactin-associated side-effects, sedation, weight gain, laboratory (urine, blood chemistry) Unable to use- GAF total score (no usable data). QTc abnormalities in ms (no usable data). |
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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 attrition rate was 33%. The last observation carried forward method was used to account for people leaving the study early. Data on study completers were also available |
Selective reporting (reporting bias) | High risk | Reporting on secondary outcomes was incomplete. |
Other bias | High risk | The study was sponsored by the manufacturer of ziprasidone. |