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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: Inpatients
Interventions 1. Mirtazapine: 20-60 mg/day, N = 103
2. Amitriptyline: 75-225 mg/day, N = 104
Flexible dosing scheduling
Outcomes The measure used for response and remission in the review: 17-item HAM-D
Other measures: MADRS, CGI-Improvement
Notes
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: “randomly allocated”
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 both of the intervention arms dropped out during the study
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