Methods | Allocation: random, no further details. Blindness: double, no further details. Duration: 24 weeks. Design: parallel. Location: multicentre. Country: USA. |
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Participants | Diagnosis: (DSM-IV) schizophrenia or schizoaffective disorder, dominant depressive symptoms, MADRS of 16 or more. N=394. Age: 18-60 years. Sex: not reported. History: duration ill not reported, age at onset not reported. Setting: in- and outpatient. |
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Interventions |
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Outcomes | Leaving the study early: any reason, adverse events, inefficacy. Global State: CGI. Mental State: PANSS total score, depression MADRS, Calgary depression scale for schizophrenia. General Functioning: GAF. Adverse effects: open interviews, EPS (use of antiparkinson medication, AIMS, BAS, SAS), cardiac effects (ECG), weight gain, laboratory (prolactin, glucose, lipids) Unable to use - PANSS (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 | 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 |
Incomplete outcome data addressed? All outcomes |
High risk | The attrition rate was high (62.7%). 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 |
Free of selective reporting? | High risk | Secondary outcomes were not fully reported. |
Free of other bias? | High risk | The study was sponsored by the manufacturer of olanzapine. |