Shinkai 2004.
Methods | Four‐week, randomised, double‐blind study. | |
Participants | Inpatients with DSM‐IV major depressive disorder without psychotic features with a minimum score of 15 on the Hamilton rating scale for depression (HDRS). Age range: 20‐78 years. | |
Interventions | Paroxetine: 21 participants. Milnacipram: 20 participants. Paroxetine mean dose: 34.28 mg. Milnacipran mean dose: 80.25 mg. No other drugs were administered throughout the study with the exception of a few patients who received benzodiazepines for insomnia. |
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Outcomes | HDRS‐17. | |
Notes | Funding: independent from industry. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomly divided into either milnacipran or the paroxetine group using StatView, a computerized statistical package" |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double blind". No further details. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double blind". No further details. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Study endpoint: 1/21 missing from paroxetine group, 0/20 missing from control group. |
Selective reporting (reporting bias) | High risk | Adverse events were not reported so that could not be entered in to the meta‐analysis. |
Other bias | Low risk | This study was independent from pharmaceutical industry. |