Methods | Allocation: random, no further details. Blindness: double, no further details. Duration: 8 weeks. Design: parallel. Location: single centre. Country: Germany. |
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Participants | Diagnosis: (DSM-IV) schizophrenia, acute episode, CGI of more than 4, PANSS total score of more than 60. N=52. Age: 18-65 years (mean olanzapine=34.47 years, mean quetiapine=36.69 years) (of completers). Sex: 21 M, 12 F (of completers, here defined as participants who completed cognitive assessments at two or more time points out of three (baseline, week 4, weeks 8)). History: duration ill mean olanzapine=4.71 years, mean quetiapine=8.44 years (of completers), age at onset mean olanzapine=29.76 years, mean quetiapine=28.25 years (of completers). Setting: inpatient. |
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Interventions |
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Outcomes | Leaving the study early: any reason, adverse events. Global state: CGI. Mental State: PANSS total score, PANSS positive subscore, PANSS negative subscore. Adverse effects: open interviews, UKU, EPS (akathisia, use of antiparkinson medication, BAS, ESRS), sedation, headache, dizziness, obstipation, weight gain Unable to use - Global state: no data. BAS: 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? Objective outcomes |
Low risk | 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? Subjective outcomes |
Unclear risk | Double, no further details. 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 attrition rate was high (61.5%). The last-observation-carried-forward 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, given the high number of attrition |
Free of selective reporting? | High risk | Data on global state have not been presented. |
Free of other bias? | High risk | The study was sponsored by the manufacturer of olanzapine. |