Methods | 8 week randomised double blind study | |
Participants | Diagnosis: DSM-IV major depressive disorder Setting: Unclear |
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Interventions | 1. Mirtazapine: 45 mg/day, N = 9 2. Fluoxetine: 40 mg/day, N = 13 Fixed dosing scheduling |
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Outcomes | The measure used for response and remission in the review: 21-item HAM-D Other measures: CGI-Severity, polysomnographic data, multiple sleep latency testing, performance vigilance testing, Epworth Sleepiness Scale |
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Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “randomly assigned” Comment: No further information provided. |
Allocation concealment (selection bias) | Unclear risk | Comment: The method of allocation is not described. |
Blinding (performance bias and detection bias) All outcomes |
Unclear risk | Quote: “double-blind” Comment: No further information provided. |
Incomplete outcome data (attrition bias) All outcomes |
High risk | More than 20% of the allocated participants to the comparator arm dropped out during the study |
Selective reporting (reporting bias) | High risk | Neither the response nor remission outcomes at the end of acute-phase treatment are provided. They needed to be imputed in the analysis |
Free of Sponsorship bias? | High risk | The funding source is the pharmaceutical company of mirtazapine |