Methods | Allocation: random, no further details. Blindness: single, rater-blinded. Duration: 12 weeks. Design: parallel. Location: single centre. Country: Israel. |
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Participants | Diagnosis: (DSM-IV) schizophrenia, PANSS negative subscore of more than 15, SANS total score more than 60. N=40. Age: 21-64 years (mean olanzapine=36.2 years, mean quetiapine=38.3 years). Sex: 32 M, 8 F. History: duration ill mean olanzapine=13.3 years, mean quetiapine=15.9 years, age at onset not reported. Setting: inpatient. |
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Interventions |
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Outcomes | Leaving the study early: any reason, adverse events, inefficacy. Mental State: PANSS total score, SANS. Adverse effects: open interviews, cardiac effects (ECG), EPS (akathisia, parkinsonism, use of antiparkinson medication, SAS, AIMS, BAS), sedation, insomnia, abdominal pain, fever, rhinitis, conjunctivitis, seizures, weight gain Unable to use - Mental State - PANSS total score (median change). Negative Symptoms - SANS (median change). EPS scales (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? Objective outcomes |
Low risk | Objective outcomes such as laboratory measures or death are unlikely to have been much affected by problems of blinding |
Blinding? Subjective outcomes |
Unclear risk | Single, rater-blind. Whether blinding was successful has not been examined, but both compounds differ quite substantially in side-effects. This can be a problem for blinding |
Incomplete outcome data addressed? All outcomes |
Low risk | The attrition rate was quite low (12%). 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. For the reason of low attrition the risk of bias can be considered as low |
Free of selective reporting? | High risk | Efficacy data (PANSS, SANS) were only presented as median change. There were no data on EPS and cardiac effects |
Free of other bias? | High risk | The study was sponsored by the manufacturer of quetiapine. |