Smith 1990.
| Methods | 6‐week, double‐blind, randomised study, number of participating centres not reported, probably single‐centre, placebo wash‐out with elimination of placebo responder | |
| Participants | Psychiatric outpatients meeting DSM‐III criteria for major depressive illness, having a minimum score 18 of on the 17‐item HAM‐D Age: total at least 18 years, total mean 43 years Sex: total M64, F86 Exclusion criteria: significant renal, hepatic, respirators, cardiovascular or cerebrovascular disease, narrow‐angle glaucoma, prostatic hypertrophy, seizure disorders, clinically relevant abnormal laboratory values or significantly abnormal ECG findings, primary diagnosis of schizophrenia, atypical depression, anxiety, adjustment or bipolar disorder, drug or alcohol abuse, suicidal tendencies, cognitive deficiencies |
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| Interventions | Amitriptyline: 50 participants Placebo: 50 participants Amitriptyline dose: range 80 to 280 mg, modal dose 111 mg |
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| Outcomes | Primary outcome: 17‐item HAM‐D Secondary outcome: Pulse, Zung, CGI‐I, EKG, Laboratory |
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| Notes | Sponsor: 2 authors are representatives from Organon Inc. Response: at least 50% HAM‐D (17‐item) reduction from baseline Remission: no definition, no data 3‐arm study comparing mirtazapine, amitriptyline and placebo (total 150 participants) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Randomly assigned", no further details |
| Allocation concealment (selection bias) | Unclear risk | Method not presented |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double‐blind" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double‐blind", no details on blinding of assessor |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | There were 60 drop‐outs (patients completing the trial N = 90 at week 6 of 150 patients), in the text only 53 drop‐outs are described, but these in a sufficiently detailed way. More participants in the placebo group dropped out due to inefficacy. Efficacy analysis included all patients who remained for at least 2 weeks in the study which was the vast majority (ITT) |
| Selective reporting (reporting bias) | High risk | Missing SDs, other outcomes seem to have all been reported |
| Other bias | Low risk | No obvious other bias |