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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: Inpatients
Interventions 1. Mirtazapine: 45-60 mg/day, N = 78
2. Venlafaxine: 75-375 mg/day, N = 79
Flexible dosing scheduling
Outcomes The measure used for response and remission in the review: 17-item HAM-D
Other measures: The Quality of Life, Enjoyment, and Satisfaction Questionnaire and Quality of Life in Depression Scale, Quality of Life in Depression Scales
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 randomised to receive treatment with either mirtazapine or venlafaxine orally for 8 weeks, prepared as indistinguishable capsules, according to a 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
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 Both the response and the remission outcomes at end of the acute-phase treatment are reported with the proportion of the participants who achieved these
Free of Sponsorship bias? High risk The funding source is the pharmaceutical company of mirtazapine