Skip to main content
. 2012 Dec 12;2012(12):CD009138. doi: 10.1002/14651858.CD009138.pub2

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"
Interventions Amitriptyline: 13 participants
Placebo: 15 participants
Amitriptyline dose: mean 109.93 ± 5.11
Outcomes Primary outcome: thyroid assay
Secondary outcome: response
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)
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