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: 15-40 mg/day, N = 66 2. Fluoxetine: 20-40 mg/day, N = 66 Flexiblie dosing scheduling |
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Outcomes | The measure used for response and remission in the review: MADRS Other measures: HAM-A, CGI-Improvement, CGI-Severity, Leeds Sleep Evaluation Questionnaire -adapted, Quality of Life Enjoyment and Satisfaction 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 | Quote: “participants were allocated to treatment with either mirtazapine or citalopram, according to the centrally prepared randomization list” Comment: No further information about actual central randomisation provided |
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 |
Low risk | Less than 20% of the participants dropped out and missing outcome data are balanced in numbers across intervention groups, with similar reasons of missing data across groups |
Selective reporting (reporting bias) | Low risk | The response outcome at the end of acute-phase treatment is provided as the proportion of the participants who achieved these |
Free of Sponsorship bias? | High risk | The funding source is the pharmaceutical company of mirtazapine |