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. 2012 Dec 12;2012(12):CD009138. doi: 10.1002/14651858.CD009138.pub2

Organon 84062 unpublished.

Methods 6‐week, double‐blind, randomised, single‐centre study, placebo wash‐out unclear
Participants Psychiatric outpatients meeting DSM‐III criteria for a major depressive episode (single or recurrent), baseline 17‐item HAM‐D ≥ 18
Age: no data
Sex: no data
Exclusion criteria: not reported
Interventions Amitriptyline: 15 participants
Placebo: 15 participants
Amitriptyline dose: no information provided
Outcomes 17‐item HAM‐D, MADRS, CGI, ZDS, PDI, drug account (primary outcome not defined)
Notes We received the data from Organon
3‐arm, dose finding study comparing mirtazapine with amitriptyline and placebo
Sponsor: Organon, The Netherlands
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomised, no further information
Allocation concealment (selection bias) Unclear risk Not explained
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Double‐blind, no further information
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Double‐blind, no further information
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Insufficient information
Selective reporting (reporting bias) Unclear risk Insufficient information
Other bias Unclear risk Insufficient information