Rush 1985.
| Methods | Randomised controlled trial, 6 weeks | |
| Participants | 52 out‐ and inpatients suffering from major depression, non‐psychotic type. At least 18 on HDRS and at least a mean REM latency less or equal to 65. Aged 18 to 65 years |
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| Interventions | Alprazolam versus amitriptyline (26/26 patients) Placebo washout 10 to 14 days Maximum dose: alprazolam 6 mg, amitriptyline 300 mg Mean final dose: alprazolam 4.4 mg, amitriptyline 190 mg |
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| Outcomes | Primary outcome: Mean HDRS after 6 weeks: alprazolam 12.7 (initial score of 24.1, SD 8.5), amitriptyline 6.9 (initial score of 26.1, SD 6.0) 50% decrease of total HDRS after 6 weeks: alprazolam 11 (44%), amitriptyline 21 (87.5%) Secondary outcome: All‐cause withdrawals: alprazolam 12 (48%), amitriptyline 8 (33%) |
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| Notes | Endpoint and raw score data analyses were employed HDRS‐17 (After 3 weeks, 32 outpatients and 17 inpatients had assessments) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Treatments were assigned on a randomized, double‐blind basis and were independent of all pretreatment clinical and laboratory evaluations." No information is provided |
| Allocation concealment (selection bias) | Unclear risk | No information is provided |
| Blinding (performance bias and detection bias) Patients | Unclear risk | Unclear if they used identical tablets |
| Blinding (performance bias and detection bias) Physicians | Unclear risk | No information is provided |
| Blinding (performance bias and detection bias) Investigators | Unclear risk | No information is provided |
| Incomplete outcome data (attrition bias) HDRS | Unclear risk | Only endpoint analysis is given while dropout rate is not equally distributed between the treatment groups |
| Incomplete outcome data (attrition bias) Withdrawals/side effects | Unclear risk | The reasons for dropping out are not listed |
| Selective reporting (reporting bias) | Unclear risk | No information is provided |
| Other bias | High risk | A selective group of patients, due to the requirement of a shortened REM latency Support from alprazolam manufacturer |
| Placebo washout | High risk | 10 to 14 days |