Methods | Allocation: random, no further details. Blindness: double, identical capsules. Duration: 52 weeks (26 weeks observed, because of small group sizes). Design: parallel. Location: multicentre. Country: USA. |
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Participants | Diagnosis: (DSM-IV) schizophrenia, inadequate efficacy in previous study, clozapine treatment (n=49) was open-label. N=99, (observed N=50). Age: 18-65 years (mean=39.7 years). Sex: 80 M, 19 F. History: duration ill, 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, PANSS positive subscore, PANSS negative subscore. Adverse effects: open interviews, amenorrhoea, galactorrhoea, sexual dysfunction, sedation, laboratory (lipids, glucose, prolactin, haemoglobin A1C level), weight gain Unable to use - Global state CGI: no data. |
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Notes | ||
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? Objective outcomes |
Low risk | Objective outcomes such as laboratory measures or death are unlikely to have been much affected by problems of blinding |
Blinding? Subjective outcomes |
Unclear risk | Double, identical capsules. Whether blinding was successful has not been examined, but the compounds differ quite substantially in side-effects. This can be a problem for blinding |
Incomplete outcome data addressed? All outcomes |
High risk | The overall attrition rate was high (74%). It is doubtful that the validity of the results was unaffected |
Free of selective reporting? | High risk | Due to small numbers and the very high attrition only data on 26 weeks treatment (rather than 52 weeks) were presented |
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. Patients had a history of former inefficacy to one of the medications. It was excluded that the same medication could be given again but still this might implicate a risk of bias due to baseline imbalance in terms of former treatment. There was no wash out period. Sponsorship was neutral |