Murthy 1991.
Methods | Randomised controlled trial, 6 weeks | |
Participants | 208 outpatients with moderate to severe depression meeting Feighner’s criteria for primary depression and DSM‐III major depression criteria | |
Interventions | Alprazolam versus imipramine (105/103 patients) Placebo 'washout' period: 3 to 7 days Maximum dosages: alprazolam 4.5 mg per day, imipramine 225 mg per day Mean dosages: alprazolam 2.5 mg per day, imipramine 125 mg per day, and 80% required less than 6 capsules of 0.5 mg per day |
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Outcomes | Primary outcome: Mean HDRS after 6 weeks: alprazolam 9.75 (initial score 23.81), SD 4.63; imipramine 9.20 (initial score of 23.44); SD 4.72 Secondary outcome: All‐cause withdrawals: alprazolam 29 (28%), imipramine 34 (33%) "The frequency of side effects was higher for imipramine compared to alprazolam. Significantly higher number of patients reported insomnia (P < 0.01) and tremor as side effects (P < 0.01). None of the side effects reported was significantly more in the alprazolam group." |
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Notes | HDRS 21 items | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Assigned in double blind random fashion." In each consecutive group, there were 3 persons who received alprazolam and 3 imipramine; but there is no further information |
Allocation concealment (selection bias) | Unclear risk | There is no information, except that "The drug code of each patient was kept in a sealed envelope which could be opened in case of emergency." |
Blinding (performance bias and detection bias) Patients | Low risk | Yes, identical capsules (there could have been a specific and rapid tranquillising effect of alprazolam) |
Blinding (performance bias and detection bias) Physicians | Low risk | Yes, identical capsules and the code was kept in a sealed envelope: "The drugs were dispensed in identical capsules, each capsule containing alprazolam 0.5 mg or imipramine 25 mg. Patients were started with one capsule twice daily. The drug code for each patient was kept in a sealed envelope which could be opened in case of emergency." |
Blinding (performance bias and detection bias) Investigators | Unclear risk | No further information is provided |
Incomplete outcome data (attrition bias) HDRS | Unclear risk | No information is provided |
Incomplete outcome data (attrition bias) Withdrawals/side effects | Unclear risk | Unclear, although dropouts are documented |
Selective reporting (reporting bias) | Unclear risk | No information is provided |
Other bias | Unclear risk | It seems that Upjohn sponsored the study |
Placebo washout | High risk | 3 to 7 days |