Methods | Allocation: random, no further details. Blindness: double, no further details. Duration: 12 weeks. Design: parallel. Location: not reported. |
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Participants | Diagnosis: (DSM-IV) schizophrenia, treatment resistance, persistant positive psychotic symptoms, BPRS total score of 35 or more plus CGI score of 4 or more. N=38. Gender: 30 M, 8 F. Age: 18-65 years (mean fluphenazine=44.2 years, mean quetiapine=43.7 years, mean risperidone=46.3 years). History: duration ill not reported, age at onset not reported. 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, BPRS positive subscore, BPRS negative subscore. Cognitive functioning: Neuropsychological testing. Quality of life: QLS. Adverse effects: open interviews, EPS (use of antiparkinson medication, SAS), prolactin increase, sexual dysfunction, sedation, weight gain, laboratory (thyroidal hormones) Unable to use- Prolactin increase: no useable data. Sexual dysfunction: no useable 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? Subjective 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 |
Blinding? Objective outcomes |
Yes | 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 |
No | Overall attrition was moderate 36%. The analysis was based on mixed effect models. It is unclear whether this statistical method can account for such a relatively high attrition rate |
Free of selective reporting? | No | Not all of the predefined adverse effects were reported. |
Free of other bias? | Unclear | There was a slight baseline imbalance in terms of mean age and the mean number of previous hospitalisations (14 in the risperidone and 9.7 in the quetiapine group) |