Methods | Allocation: random, no further details. Blindness: double, no further details. Duration: six weeks. Design: parallel. Location: multicentre. |
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Participants | Diagnosis: (DSM-IV) acute schizophrenia (n=170) or schizoaffective disorder (n=99). CGI-S score ≥4, CGI-I score ≥3. N=269. Age: 18-55 years (mean olanzapine=37.6 years, mean ziprasidone=37.7 years). Gender: 176 M, 93 F. History: duration of illness mean olanzapine=14.0, mean risperidone=15.4, age at onset mean olanzapine=23.7 years, mean ziprasidone=22.2 years. Setting: inpatient. |
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Interventions |
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Outcomes | Leaving the study early: any reason, adverse events, inefficacy. Global State: CGI. Mental State: BPRS total score, depression Calgary depression scale for schizophrenia. Adverse effects: open interviews, EPS (use of antiparkinson medication, ESRS) cardiac effects (ECG), weight gain, laboratory Unable to use- Laboratory (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 overall attrition was high (42.8%).The last observation carried forward method was used to account for people leaving the study early |
Selective reporting (reporting bias) | High risk | The study focused on acutely ill schizophrenic or schizoaffective patients but data on the positive symptom subscore were not provided |
Other bias | High risk | The study was sponsored by the manufacturer of ziprasidone. The upper dose limit of olanzapine was 15 mg/day which is below the maximum dose for this medication |