Methods | Allocation: randomised. Blindness: double. Duration: 8 weeks. |
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Participants | Diagnosis: (CCMD-3) schizophrenia. N=61. Age: mean clozapine=30 years, mean olanzapine=25.8 years. Gender: 29 M, 32 F. Setting: in- and outpatient. History: duration ill mean= 4.2 years, age at onset not reported |
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Interventions |
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Outcomes | Mental state: BPRS total score. Adverse effects: at least one adverse effect, extrapyramidal side effects (extrapyramidal symptoms), sedation, weight gain Unable to use: White blood cell countleukopenia (no usable data). Leaving the study early -adverse events (no usable data). Hypersalivation (no usable data). |
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Notes | ||
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Random, no further details. |
Allocation concealment? | Unclear | No further details. |
Blinding? All outcomes |
Unclear | Double, no further details. Whether blinding was successful has not been examined, but both compounds differ quite substantially in side-effects. This can be a problem for blinding Objective outcomes such as laboratory measures or death are unlikely to have been much affected by problems of blinding. This latter, probably leads a low risk of bias |
Incomplete outcome data addressed? All outcomes |
No | Data on leaving the study early were not provided. |
Free of selective reporting? | No | Data were not available for all of the predefined adverse effect outcomes |
Free of other bias? | No | The sponsor was unclear. The upper dose range limit of clozapine was 400 mg/day which was reached rather quickly (10 days), which could mean a disadvantage for cloza-pine in terms of side-effects |