Roffman 1982.
| Methods | 4‐week, double‐blind, randomised, multi‐centre study, placebo wash‐out with elimination of placebo responder | |
| Participants | Psychiatric outpatients meeting DSM criteria for major depressive disorder (296.2 and 296.3), moderately ill, having a minimum score of 18 on the 17‐item HAM‐D Age: range for AMI and PBO 18 to 65 years Sex: AMI M53, F42; PBO M54, F40 Exclusion criteria: history or evidence of clinically significant: renal disease, BUN or creatinine elevations, hepatic disease, liver enzyme elevations, cardiovascular diseases, metabolic diseases, seizure disorders, hypersensitivity to TCA or related compounds, cerebrovascular disease, drug abuse, alcoholism or endocrine disease. Also patients with adjustment disorders, manic‐depressive illness, recurrent type schizophrenia and primary anxiety disorder were excluded. |
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| Interventions | Amitriptyline: 95 participants Placebo: 94 participants Amitriptyline dose: range 75 mg to 150 mg |
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| Outcomes | Primary outcome: HAM‐D Secondary outcome: CGI |
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| Notes | Sponsor: Ciba‐Geigy Response: 50% reduction in Hamilton score from Visit 1 to endpoint visit or value of 12 or less in Hamilton Score Remission: no definition, no data 3‐arm study comparing oxaprotiline with amitriptyline and placebo The data from 30 participants with protocol violations were not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomized", "randomly divided" |
| 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 | High risk | 30 dropped out due to protocol violations after randomisation, reason and group of participants not reported, “in addition data from certain visits from 20 of the remaining 278 patients were also excluded from the efficacy analysis for the same reason” (protocol violations). Numbers do not add up |
| Selective reporting (reporting bias) | Low risk | No obvious selective reporting |
| Other bias | Low risk | No clear other bias |