Methods | Allocation: random, no further details. Blindness: double, double-dummy protocol. Duration: 29 weeks. Design: parallel. Location: multicentre. |
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Participants | Diagnosis: (DSM-IV) schizophrenia (n = 93) or schizoaffective disorder (n = 14), treatment resistance, moderate severity score on BPRS or SANS. N = 107. Sex: 84 M, 23 F. Age: 18-60 years (mean = 42 years). History: duration ill n.i., age at onset mean clozapine = 23 years, mean risperidone = 22 years. Setting: in- and outpatient. |
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Interventions |
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Outcomes | Leaving the study early: any reason, adverse events, inefficacy. Global State: CGI. General Mental State: BPRS total score, SANS. Cognitive functioning: Spatial working memory performance, social skill and problem solving assessment. Adverse effects: TESS, laboratory (hematology). Unable to use: SANS (modified version). |
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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, double-dummy protocol. 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 | The overall attrition was high 63.9%. The analysis was based on mixed effect models, but it is unclear whether any statistical method can account for such a high dropout rate |
Free of selective reporting? | High risk | Outcome reporting was incomplete. Quote: “…adverse events data have been reported elsewhere (unpublished study of N.R. Schooler et al.) |
Free of other bias? | Low risk | Review authors did not find other sources of bias. Probably yes |