Methods | Allocation: random, no further details. Blindness: double, no further details. Duration: 8 weeks. Design: parallel. Location: multicenter. |
|
Participants | Diagnosis: (DSM-III-R) chronic schizophrenia, non-responders or intolerance, PANSS between 60 and 120. N = 86. Sex: 61 M, 25 F. Age: 18-65 years (mean = 37.3). History: age at first hospitalisation mean clozapine = 25.0, mean risperidone = 26.0, age at onset mean clozapine = 23.5, mean risperidone = 22.4. Setting: inpatient. |
|
Interventions |
|
|
Outcomes | Leaving the study early: any reason, adverse events, inefficacy. Mental State: PANSS total score, PANSS positive subscore, PANSS negative subscore). Adverse effects: cardiac effects, EPS (akinesia, dystonia, parkinsonism, use ofantiparkin-son medication), prolactin associated side effects (sexual dysfunction), sedation, failing memory, concentration difficulties, nausea, weight gain, laboratory (hematology) Unable to use: Change of weight in kg (no usable data). |
|
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, 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 |
Unclear risk | The overall attrition was moderate (20.9%) . The LOCF method was used to account for people leaving the study early. It assumes that a participant who discontinued the study would not have had a change of his condition if he had remained in the study. This assumption can obviously be wrong |
Free of selective reporting? | High risk | Secondary outcomes were not fully reported. For treatment emergent adverse events there was an incidence ofat lest 5% occurrence for being reported |
Free of other bias? | High risk | The study was sponsored by the manufacturer of risperidone. |