Organon 84062 unpublished.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 |
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Interventions | Amitriptyline: 15 participants Placebo: 15 participants Amitriptyline dose: no information provided |
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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 |
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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 |