Methods | Allocation: random, no further details. Blindness: double, no further details. Duration: 24 weeks. Design: parallel. Location: multicentre. |
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Participants | Diagnosis: (DSM-IV) schizophrenia or schizoaffective disorder, dominant depressive symptoms, MADRS ≥16. N=394. Age: 18-60 years. Gender: not reported. History: duration of illness 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 |
Random sequence generation (selection bias) | Unclear risk | Random, no further details. |
Allocation concealment (selection bias) | Unclear risk | No further details. |
Blinding (performance bias and detection bias) 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 |
Blinding (performance bias and detection bias) 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 (attrition bias) All outcomes |
High risk | The overall attrition was very high (62. 7%). The last observation carried forward method was used for people leaving the study early |
Selective reporting (reporting bias) | High risk | Secondary outcomes were not fully reported. |
Other bias | High risk | The study was sponsored by the manufacturer of olanzapine. |