Reimherr 1990.
| Methods | 8‐week, double‐blind, randomised, multi‐centre study, placebo wash‐out with elimination of placebo responder | |
| Participants | Psychiatric outpatients meeting DSM‐III criteria for major depression, having a minimum score 18 of on the 18‐item HAM‐D Age: AMI mean 37.7; PBO mean 40.1 Sex: AMI M65, F84; PBO M72, F78 Exclusion criteria: patients not meeting DSM‐III criteria for MD, pregnant or lactating females, females of childbearing potential not presently using an adequate method of contraception; patients receiving concurrent psychotherapeutic medication or concomitant medications other than oestrogens, progesterone and diuretics, patients with other significant medical conditions; patients receiving another investigational drug within 4 weeks of enrolling in this study; patients with a history of serious intolerance or resistance to antidepressant medications; patients with an alcohol or drug abuse condition, patients with schizophrenia or schizoaffective disorder |
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| Interventions | Amitriptyline: 149 participants Placebo: 150 participants Amitriptyline dose: 50 mg to 150 mg, mean 104 mg, flexible dosing schedule |
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| Outcomes | Primary outcome: 17‐item HAM‐D, CGI‐Improvment Secondary outcome: change SCL |
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| Notes | Sponsor: unclear Response: ≥ 50% decrease in HAM‐D total score between baseline and final visits Remission: no definition, no data 3‐arm study comparing sertraline to amitriptyline and placebo (total 448 participants) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Randomly allocated", no further details |
| Allocation concealment (selection bias) | Unclear risk | Method not described |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double‐blind", "in a double‐blind manner" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double‐blind", "in a double‐blind manner", no details on blinding of assessor |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | A similar number of participants in each group dropped out (˜50%), but more in the amitriptyline group due to adverse events. Details were reported. It appears that ITT analysis was done ("baseline to last visit"), however, there was an additional completer analysis |
| Selective reporting (reporting bias) | Low risk | No obvious selective reporting |
| Other bias | Low risk | No obvious other bias |