Methods | Allocation: random, no further details. Blindness: double, identical capsules. Duration: 12 weeks. Design: parallel. Location: not reported. |
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Participants | Diagnosis: (DSM-IV or ICD-10) schizophrenia, predominant negative symptoms, CGI of 4 or more, PANSS negative subscore of 21 or more. N = 44. Sex: 27 M, 17 F. Age: mean quetiapine = 30.6 years, mean risperidone = 39.3 years. History: duration ill mean quetiapine = 5.4 years, mean risperidone = 2.5 years, age at onset mean quetiapine = 25.3 years, mean risperidone = 36.9 years. Setting: partially in- and outpatient. |
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Interventions |
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Outcomes | Leaving the study early: any reason, adverse events, inefficacy. Mental State: PANSS total score, PANSS positive subscore, PANSS negative subscore, SANS total score. Cognitive functioning: auditory verbal memory test, Trail Making Test, Wechsler visual memory scale. Adverse effects: open interviews, cardiac effects (ECG), EPS (akathisia, parkinsonism, use of antiparkinson medication, SAS), sedation, headache, nausea, insomnia, dizziness, weight gain, laboratory (prolactin) Unable to use: SANS total score: no data. Prolactin change from baseline in ng/ml: no data. Cardiac effects: 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 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 (45.2%). The data were analysed using both a LOCF method and a study completer approach. Nevertheless, it is questionable whether any statistical method can account for such a high attrition |
Free of selective reporting? | High risk | Data on negative symptoms (SANS) and some adverse effects were not available |
Free of other bias? | High risk | The study was sponsored by the manufacturer of quetiapine. |