Methods | Allocation: random, no further details. Blindness: double, identical capsules. Duration: 6 weeks. Design: parallel. |
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Participants | Diagnosis: (DSM-IV) schizophrenia disorganised (n = 9), paranoid (n = 22) or undifferentiated (n = 16) (of intent-to-treat population). N = 48. Age: 18-65 years (mean amisulpride = 36.3 years, mean risperidone = 34.1 years). Sex: 20 M, 27 F (of intent-to-treat population). Location: multicentre. Setting: not described. History: duration ill mean amisulpride = 13.3 years, mean risperidone = 13.4 years, age at onset not reported |
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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, BPRS total, PANSS positive subscore, PANSS negative subscore. General functioning: SOFAS total score. Adverse effects: open interviews, cardiac effects (QTc interval of > 500 ms), EPS (akathisia, rigor, tremor, use of antiparkinson medication), weight, laboratory (hematology, blood chemistry, urinanalysis) Unable to use: ESRS: no data. Leukopenia: 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? subjective outcomes |
Unclear risk | Double, identical capsules. Whether blinding was successful has not been examined, but both compounds differ in side effects. This may 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 |
Low risk | The rate of participants leaving the study early was below 10% and data on reasons for drop-out were available. The data were analysed on an intent-to-treat basis with the LOCF method. This method is not perfect, but due to the very low attrition the risk of bias was low |
Free of selective reporting? | High risk | Data on the extrapyramidal symptom scale have not been presented. Only those adverse events that occurred in at least 5% of the participants were reported. This procedure can miss rare, but important adverse events |
Free of other bias? | High risk | The study was sponsored by the manufacturer of amisulpride. |