Methods | Allocation: random, 33 participants were assigned to a three-arm randomisation (1:1:1, blocks of 15) and 18 participants with a history of adverse experiences with haloperidol were assigned to a two-arm randomisation (1:1) for risperidone and olanzapine only. Blindness: double, no further details. Duration: 8 weeks. Design: parallel. Location: multicentre. |
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Participants | Diagnosis: (DSM-IV) schizophrenia or schizoaffective disorder. N = 51. Sex: 43 M, 8 F. Age: 18-60 years (mean = 48.8 years). History: duration ill not reported, age at onset not reported. Setting: not reported. |
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Interventions |
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Outcomes | Neurological functioning: Prepulse inhibition, EMG. | |
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Random, 33 participants were assigned to a three-arm randomisation (1:1:1, blocks of 15) and 18 participants with a history of adverse experiences with haloperidol were assigned to a two-arm randomisation (1:1) for risperidone and olanzapine only |
Allocation concealment? | Unclear risk | No further details. |
Blinding? subjective outcomes |
Unclear risk | Double, no further details. Whether blinding was successful has not been examined, but the compounds differ quite substantially in side effects. This can 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 |
High risk | Data on leaving the study early were not available. |
Free of selective reporting? | High risk | Efficay outcomes such as the general mental state (PANSS total score) were not presented |
Free of other bias? | High risk | The study was sponsored by the manufacturer of risperidone. |