Mynors‐Wallis 1995.
| Methods | 12‐week, double‐blind, randomised, single‐centre study, placebo wash‐out unclear | |
| Participants | Patients meeting RDC criteria for major depression, having a minimum score of 13 on the 17‐item HAM‐D, focusing on general care setting Age: range AMI 18 to 58 years; PBO 21 to 60 years Sex: AMI M7, F24; PBO M9, F21 Exclusion criteria: another psychiatric disorder before onset of depression, receiving current psychological or antidepressant drug therapy, current psychotic symptoms, serious suicidal intent, history of schizophrenia, recent drug or alcohol misuse, physical problems contraindicating amitriptyline treatment |
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| Interventions | Amitriptyline: 31 participants Placebo: 30 participants Amitriptyline dose: maximum 150 mg, mean dose 139 mg, fixed dosing schedule |
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| Outcomes | Primary outcome: Present State Examination, 17‐item HAM‐D Secondary outcome: BDI, modified social adjustment scale |
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| Notes | Sponsor: Wellcome Trust funded a training fellowship for 1 author, Warner‐Lambert provided amitriptyline and placebo Response: no definition, no data Remission: recovery criteria are HAM‐D score ≤ 7 and BDI ≤ 8 3‐arm study comparing problem‐solving treatment, amitriptyline plus standard clinical management and placebo plus standard clinical management (total 91 participants) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomised controlled trial,...", "randomly allocated", "stratified to make sure that the three groups contained patients with depressive symptoms of similar severity" |
| Allocation concealment (selection bias) | Low risk | Quote: "System of sealed envelopes" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Identical capsules", "both patient and therapist were blind to the content of the capsules" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Identical capsules", "double‐blind", "two experienced research interviewers who were blind to treatment" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Reasons for withdrawals reported, 82 (at least 4 therapy sessions) out of 91 patients included in ITT analysis |
| Selective reporting (reporting bias) | Low risk | Data for all outcomes reported |
| Other bias | Low risk | No obvious other bias |