Methods | 8 week randomised double blind study | |
Participants | Diagnosis: DSM-IV major depressive disorder Setting: In- and outpatients |
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Interventions | 1. Mirtazapine: 30-60 mg/day, N = 147 2. Fluoxetine: 20-40 mg/day, N = 152 Flexible dosing scheduling |
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Outcomes | The measure used for response and remission in the review: 17-item HAM-D Other measures: MADRS, CGI-Severity, Leeds Sleep Evaluation Questionnaire, Quality of Life, Enjoyment and Satisfaction Questionnaire, Changes in Sezual Functioning Questionnaire |
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Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “randomised” 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 |
Unclear risk | The numbers of dropouts in the both arms are not specified. |
Selective reporting (reporting bias) | Low risk | The response outcome at the end of acute-phase treatment is provided in the figure as the proportion of the participants who achieved this |
Free of Sponsorship bias? | High risk | The funding source is the pharmaceutical company of mirtazapine |