Remick 1988.
| Methods | Randomised controlled trial, 6 weeks | |
| Participants | 52 outpatients suffering from major depressive disorder (12 dropped out before analysis), with a score of at least 21 on HDRS | |
| Interventions | Alprazolam versus desipramine (19/21 patients) Placebo 'washout' period 3 to 14 days Maximum dose: alprazolam 4.5 mg, desipramine 225 mg Mean daily dose at the end: alprazolam 3.34 mg, desipramine 192 mg |
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| Outcomes | Primary outcome: Mean HDRS after 6 weeks: alprazolam 12.0 (initial 26.3), desipramine 17.5 (initial 26.0) Secondary outcome: All‐cause withdrawals: alprazolam 6 (31.6%), desipramine 7 (33.3%) Withdrawals due to side effects: alprazolam 4 (21.1%), desipramine 5 (23.8%) |
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| Notes | There seems to be an overlap with the Remick 1985 paper. The 2 car accidents and the side effects profile are the same, but this study has larger samples and allows for a higher maximum dosage. 21 patients completed an all‐night polysomnographic recording and 37 completed a modified dexamethasone suppression test HDRS‐17 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Patients were blindly assigned to either alprazolam or desipramine." No information is provided |
| Allocation concealment (selection bias) | Unclear risk | No information is provided |
| Blinding (performance bias and detection bias) Patients | Low risk | "Medicine was dispensed in opaque gelatine capsules containing...in a dose‐dispensing system administered by a pharmacist." |
| Blinding (performance bias and detection bias) Physicians | Low risk | "Weekly assessments were completed by the research psychiatrist..." Drugs were distributed by the pharmacist. |
| Blinding (performance bias and detection bias) Investigators | Unclear risk | No information is provided |
| Incomplete outcome data (attrition bias) HDRS | Low risk | 40 patients enrolled of whom 29 were analysed for 6 weeks treatment. There was also an analysis for all 40 patients. Number and reasons for dropping out are equally distributed between the treatment groups. |
| Incomplete outcome data (attrition bias) Withdrawals/side effects | Unclear risk | It is not specified when the patients dropped out during the study |
| Selective reporting (reporting bias) | High risk | SD not reported |
| Other bias | High risk | "There was a trend for desipramine patients to have more previous episodes than the alprazolam group. In addition, more desipramine patients had their current episode characterized as an exacerbation of a chronic condition while more alprazolam patients were having their first occurrences with no previous psychiatric illness." Group differences Support from alprazolam manufacturer |
| Placebo washout | High risk | 3 to 14 days |