Methods | Allocation: random, no further details. Blindness: double, no further details. Duration: 8 weeks. Design: parallel. Location: single centre. Country: China. |
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Participants | Diagnosis:(CCMD-3) schizophrenia. N=61. Age: mean clozapine=30 years, mean olanzapine=25.8 years. Sex: 29 M, 32 F. History: duration ill mean=4.2 years, age at onset not reported. Setting: in- and outpatient. |
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Interventions |
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Outcomes | Leaving the study early: adverse events. Mental State: BPRS total score. Adverse effects: open interviews, cardiac effects (palpitation, blood pressure), EPS, sedation, dry mouth, congestion, weight gain, laboratory (leukopenia) Unable to use - Leaving the study early - adverse events (no usable data). Leukopenia (no usable 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, 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 |
Incomplete outcome data addressed? All outcomes |
High risk | Data on leaving the study early were not provided. |
Free of selective reporting? | High risk | Data were not available for all of the predefined adverse effect outcomes |
Free of other bias? | High risk | The sponsor was unclear. The upper dose range limit of clozapine was 400mg/day which was reached rather quickly (10 days), which could mean a disadvantage for clozapine in terms of side effects |