Methods | Allocation: random, no further details. Blindness: single, rater-blinded. Duration: 6 weeks. Design: parallel. Location: single centre. |
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Participants | Diagnosis: (DSM-IV) schizophrenia. N=56. Sex: 24 M, 29 F (3 not reported) Age: 19-46 years (mean clozapine = 31.3 years, mean olanzapine = 29.6 years, mean quetiapine = 30.1 years, mean risperidone = 27.9 years, mean control group = 32.1 years). History: duration ill mean clozapine = 6.6 years, mean olanzapine = 6.3 years, mean quetiapine = 5.9 years, mean risperidone = 5.6, age at onset: not reported |
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Interventions |
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Outcomes | Leaving the study early: any reason. Mental State: PANSS total score. Adverse effects: EPS (use of antiparkinson medication), weight gain (BMI), laboratory (serum leptin, triglyceride levels) |
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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 | Single, rater-blind. 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 |
Low risk | Three subjects in the control groups left the study early (5.4%). Reason for dropout were not assessed, only completer data were presented. But due to the very low rate we do not think that there was a risk of bias |
Free of selective reporting? | Low risk | Probably free of bias. The study focused on serum leptin and triglyceride levels which were adequately described |
Free of other bias? | Unclear risk | Data on the allowed dose range have not been presented. Furthermore, the pre-study treatment was quite heterogeneous as 19 participants had never taken any psy-chotropic drugs while most other participants had a long history of previous treatment |