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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 5 week randomised study
Participants Diagnosis: DSM-IV major depressive episode (bipolar disorder not included)
Setting: Psychiatric inpatients
Interventions 1. Mirtazapine: 45 mg/day, N = 20
2. Reboxetine: 8 mg/day, N = 20
Fixed dosing scheduling
Outcomes The measure used for response and remission in the review: 21-item HAM-D
Other measures: Hypothalamic-pituitary-adrenocortical axis activity
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 Comment: The method of allocation is not described.
Blinding (performance bias and detection bias)
All outcomes
High risk Quote: “We abstained from blinding the medication because the side effect profiles of reboxetine and mirtazapine markedly differ"
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 numbers of the participants who achieved this
Free of Sponsorship bias? High risk The funding source is the pharmaceutical company of mir-tazapine