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. Author manuscript; available in PMC: 2014 Sep 9.
Published in final edited form as: Cochrane Database Syst Rev. 2011 Dec 7;(12):CD006528. doi: 10.1002/14651858.CD006528.pub2
Methods 8 week randomised double blind study
Participants Diagnosis: DSM-IV major depressive disorder
Setting: In- and outpatients
Interventions 1. Mirtazapine: 15-40 mg/day, N = 66
2. Fluoxetine: 20-40 mg/day, N = 66
Flexiblie dosing scheduling
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
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