Meyers 2009.
Study characteristics | ||
Methods | Randomised double‐blind study | |
Participants | 259 participants; DSM‐IV‐TR psychotic depression; 18 years of age or older; HAM‐D ≧ 21 and SADS delusional severity rating ≧ 3 Inpatients |
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Interventions | 12 weeks' treatment with olanzapine + placebo and olanzapine + sertraline | |
Outcomes | Remission rates (HAM‐D 17 ≦ 10 and SADS delusional item score = 1) | |
Notes | 53% dropout in olanzapine arm and 37% dropout in olanzapine + sertraline arm | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | As reported: "computer generated randomisation list" |
Allocation concealment (selection bias) | Unclear risk | No further data |
Blinding (performance bias and detection bias) of participants | Low risk | Study was double‐blind (reported as: "sertraline and placebo under double‐blind conditions") |
Blinding (performance bias and detection bias) of personnel | Low risk | Well‐described double‐blinding. "Sertraline and placebo under double‐blind conditions". As reported: "investigators and raters were blind to treatment assignment" |
Blinding (performance bias and detection bias) of outcome assessors | Low risk | Well‐described double‐blinding. "Sertraline and placebo under double‐blind conditions". As reported: "investigators and raters were blind to treatment assignment" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None |
Selective reporting (reporting bias) | Low risk | Protocol available. Generally accepted outcomes have been used |
Other bias | Unclear risk | Relatively high dropout rate with significant differences between treatment groups (53% olanzapine and 37% olanzapine + sertraline) Patients with only hallucinations excluded |