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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: Unclear
Interventions 1. Mirtazapine: 45 mg/day, N = 9
2. Fluoxetine: 40 mg/day, N = 13
Fixed dosing scheduling
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
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