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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 major depressive disorder
Setting: Outpatients
Interventions 1. Mirtazapine: 5-35 mg/day, N = 50
2. Amitriptlyline: 40-280 mg/day, N = 50
3. Placebo, N = 50
Flexible dosing scheduling
Outcomes The measure used for response and remission in the review: 17-item HAM-D
Other measures: MADRS, CGI-Improvement, CGI-Severity, Zung Self-Rating Depression Scale
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 concealment 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
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 this
Free of Sponsorship bias? High risk The funding source is the pharmaceutical company of mirtazapine