Thomson 1982.
| Methods | 12‐week, double‐blind, double‐dummy, randomised, multi‐centre study, placebo wash‐out with elimination of placebo responder | |
| Participants | Psychiatric outpatients meeting RDC criteria for major affective disorder, having a minimum score of 12 on the HAM‐D (unclear how many items) Age: range 18 to 65 years, median (total) 33 years Sex: total M25, F115 Exclusion criteria: receiving antidepressants in the previous 2 weeks, contraindication to TCA |
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| Interventions | Amitriptyline: 31 participants Placebo: 28 participants Amitriptyline dose: fixed dosing schedule, dosage is described as 100 mg per day and in results as 150 mg per day |
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| Outcomes | Primary outcome: first 18 items of the 21‐item HAM‐D, number of items unclear Secondary outcome: Present State Examination, 5‐point Global State of Depression, plasma tryptophane levels |
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| Notes | Sponsor: Berk Pharmaceuticals Response: no definition, no data Remission: defined as a fall to 4 points or less on the total HAM‐D score 4‐arm study comparing amitriptyline with tryptophane, a combination of amitriptyline and tryptophane and with placebo |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Allocation to treatment was random, but balanced within each group practice", no further details |
| Allocation concealment (selection bias) | Unclear risk | Method not described |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double‐dummy technique for drug administration" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double‐dummy technique for drug administration", assessments were made by a research psychiatrist, not the treating psychiatrist, no details on blinding of assessor |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Unclear whether randomisation was done before or after run‐in period so that some numbers are unclear. Clearly more drop‐outs due to inefficacy in the placebo group. Very much modified ITT (at least one assessment after 4 weeks). |
| Selective reporting (reporting bias) | High risk | No standard deviations, no numbers for all side effects |
| Other bias | Low risk | No obvious other bias |