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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 6 week randomised double blind study
Participants Diagnosis: DSM-III-R major depressive disorder
Setting: In- and outpatients
Interventions 1. Mirtazapine: 15-60 mg/day, N = 66
2. Fluoxetine: 20-40 mg/day, N = 67
Flexible dosing scheduling
Outcomes The measure used for response and remission in the review: 17-item HAM-D
Other measures: CGI-Severity, the Visual Analogue Mood Rating Scale, 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 fluoxetine, according to the centrally prepared randomization list”
Comment: No further information about actual central randomization 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
High risk More than 20% of the allocated participants to both of the intervention arms dropped out during the study
Selective reporting (reporting bias) Low risk The response and remission outcomes at the end of acute-phase treatment are provided in the figures as the proportion of the participants who achieved these
Free of Sponsorship bias? High risk The funding source is the pharmaceutical company of mirtazapine