Kusalic 1993.
Methods | 6‐week, double‐blind study, number of study centres not reported, placebo lead‐in period of 1 week, exclusion of placebo responder not reported | |
Participants | Psychiatric outpatients meeting DSM‐III‐R criteria for major depressive episode, having a minimum score 18 of on the 17‐item HAM‐D Age: range (total) 22 to 61 years, mean (total) 41.3 ± 10.1 Sex: M24, F14 (total) Inclusion criteria: "Subjects were in good physical health according to physical examination, blood count, T3/4 laboratory and ECG" |
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Interventions | Amitriptyline: 13 participants Placebo: 15 participants Amitriptyline dose: mean 109.93 ± 5.11 |
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Outcomes | Primary outcome: thyroid assay Secondary outcome: response |
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Notes | Sponsor: unclear Response: "improvement: 50% decline in the HRSD score by the end of the treatment period" Remission: no definition, no data 3‐arm study comparing amitriptyline, moclobemide and placebo (total 39 patients) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details presented, assumed because double‐blind trial |
Allocation concealment (selection bias) | Unclear risk | Quote: “The medication was given in capsules that were identical in shape, size and color”, "double‐blind" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: “The medication was given in capsules that were identical in shape, size and color”, "double‐blind" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: “The medication was given in capsules that were identical in shape, size and color”, "double‐blind", no details on blinding of assessor |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Drop‐outs not presented, unclear whether there were any |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | There appear to be 2 typos about numbers, no obvious other bias |