Methods | Allocation: random, no further details. Blindness: double, identical capsules. Duration: 22 weeks (last 12 weeks observed). Design: parallel. Location: multicentre. |
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Participants | Diagnosis: (DSM-IV) schizophrenia (n = 24) or schizoaffective disorder (n = 12). N = 36. Sex: 17 M, 19 F. Age: mean = 47.0 years. History: duration ill not reported, age at onset not reported. Setting: outpatient. |
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Interventions |
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Outcomes | Mental State: PANSS total score, PANSS positive subscore, PANSS negative subscore. Adverse effects: EPS (SAS), weight gain. Unable to use: Leaving the study early: 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 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 | Standard deviations for the primary outcome were not available |
Free of other bias? | High risk | Dose ranges were not indicated. The study was sponsored by the manufacturer of risperidone |