Methods | Allocation: random, no further details. Blindness: double, identical capsules. Duration: 78 weeks. Design: parallel. Location: multicentre. |
|
Participants | Diagnosis: (DSM-IV) schizophrenia, previously more than one schizophrenic episode, responder. N = 1493. Age: 18-65 years (mean = 40.6 years). Sex: 1080 M, 380 F. History: duration not reported, age at onset not reported. Setting: in- and outpatient. |
|
Interventions |
|
|
Outcomes | Leaving the study early: any reason, adverse events, inefficacy. Global State: CGI-S. Mental State: PANSS total score. Service use: number of patients re-hospitalised. Death: suicide attempt. Adverse effects: open interviews, EPS (use of antiparkinson medication, akathisia), cardiac effects (ECG), prolactin-associated side effects, sedation, weight gain, laboratory (prolactin, lipids, glucose) Unable to use: Withdrawal due to “extrapyramidal effects” (no usable data). |
|
Notes | Note: 33 patients were excluded before analysis. | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Random, no further details. |
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 (75%), and it is unclear whether any statistical method can account for such a high drop-out rate. Efficacy outcomes were evaluated based on mixed effects model analysis |
Free of selective reporting? | Low risk | There was no evidence for selective reporting. |
Free of other bias? | Unclear risk | Dose ranges were quite different, the upper dose range of olanzapine was 30 mg whereas risperidone could only be titrated up to 6mg /day. There was no wash-out period. An overlap in the administration of formerly given antipsychotics was permitted for the first four weeks after randomisation. Allocation to ziprasidone treatment was not possible from the start of the study due to the later availability of ziprasidone |