Draper 1983.
| Methods | Randomised controlled trial, 6 weeks | |
| Participants | 36 o utpatients with neurotic/reactive depression and a minimum RDS of 8 which had to equal or exceed the CAS score indicating that depression predominated. They had to satisfy FDC criteria for primary affective disorder and achieve a minimum score of 17 on the HDRS. 201 had a diagnosis of depression (151 of whom had neurotic depression). 60 did not fulfil severity criteria, 30 refused, or had other treatment etc., 25 left because of physical illness, 16 had wrong age, 11 responded to existing therapy, and 7 had the wrong clinical presentation. Of 52 participants remaining, 51 had neurotic depression and of these 36 met the inclusion criteria, 11 failed to reattend and 15 were ultimately available for the final assessments. Aged 18 to 60 years |
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| Interventions | Alprazolam versus amitriptyline Placebo wash‐out period 4 to 7 days Mean dosage: 2.15 mg alprazolam per day and 85 mg amitriptyline per day |
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| Outcomes | Primary outcome: Mean HDRS after 4 weeks: alprazolam 8.25 (initial 26), amitriptyline 8.06 (initial 26) Secondary outcome: All‐cause withdrawals: alprazolam 8 (27%), amitriptyline 8 (27%) Withdrawals due to side effects: Alprazolam 3 (10%), amitriptyline 0 (0%) |
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| Notes | At 6 weeks n = 10, alprazolam and n = 10 to n = 5 for amitriptyline | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | “The design of the study was double blind with random allocation.” No further information provided |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding (performance bias and detection bias) Patients | Low risk | “...in matched capsules.” “The design of the study was double blind” We assume patients were blinded |
| Blinding (performance bias and detection bias) Physicians | Unclear risk | No information provided |
| Blinding (performance bias and detection bias) Investigators | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) HDRS | High risk | 31% of the recruited patients were non‐available |
| Incomplete outcome data (attrition bias) Withdrawals/side effects | High risk | “Two‐thirds of the alprazolam treated group remained in trial at week six compared with one half of the amitriptyline treated group.” Of the 15 patients in the alprazolam group, 10 were available at the end, while for the amitriptyline group, of the 10 patients, 5 were available |
| Selective reporting (reporting bias) | Unclear risk | No information provided |
| Other bias | High risk | Dosing of medication, at least for amitriptyline |
| Placebo washout | High risk | 4 to 7 days |