Asakura 2005.
Methods | Four‐week double blind, single‐centre, randomised study. | |
Participants | Psychiatric in‐ and outpatients meeting major depressive disorder or other affective disorder according to DSM‐IV. Baseline HRSD score: 20.02 (SD 6.60). Age: 20 years old or more, mean 41.3 years old (SD 13.7). Exclusion criteria: treated with any antidepressants for the current depressive episode. | |
Interventions | Fluvoxamine: 158 participants. Imipramine: 161 participants. Fluvoxamine dose range: 50‐150 mg/day. Imipramine dose range: 75‐150 mg/day. | |
Outcomes | HRSD‐17, CGI. Total dropout. |
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Funded by pharmaceutical companies | Funded by pharmaceutical companies market fluvoxamine and comparator drug. | |
Fluvoxamine as an investigational or comparator drug | As an investigational drug. | |
Notes | Almost all the patients were drug naive outpatients. 17% (54/309) of participants were with dysthymic disorder, depressive disorder not otherwise specified, bipolar II disorder or major depressive disorder with psychotic features. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "patients were randomized", no further details. |
Allocation concealment (selection bias) | Unclear risk | No details. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: "double blind", no further details. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Study endpoint: 9/158 missing from fluvoxamine group; 12/161 missing from control group. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement. |