Amore 1989.
Methods | Four‐week double blind, randomised study. | |
Participants | Psychiatric inpatients meeting DSM‐III for major depression without psychotic features, with a minimum baseline score of 21 on the HDRS‐21. Age range: 20‐70 years old. Exclusion criteria: during pregnancy, lactation, or being of childbearing potential, serious diseases, alcohol or drug abuse, or treatment with any medications that might interact with antidepressant drugs. | |
Interventions | Fluvoxamine: 15 participants.
Imipramine: 15 participants.
Fluvoxamine dose range: 100‐150 mg/day.
Imipramine dose range: 100‐150 mg/day. Benzodiazepine were allowed as additional medications. |
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Outcomes | Hamilton Rating Scale for Depression (HRSD) ‐21, Zung Self‐Rating Depression Scale, Clinical Global Impression‐severity (CGI‐S) and Clinical Global Impression‐improvement (CGI‐I). Total dropout, dropout due to inefficiency, due to side effects, side effect profile. |
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Funded by pharmaceutical companies | Funded by pharmaceutical company markets fluvoxamine. | |
Fluvoxamine as an investigational or comparator drug | As an investigational drug. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomly assigned", no further details. |
Allocation concealment (selection bias) | Unclear risk | No details. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: "in a double blind fashion", no further details. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Study endpoint: 5/15 missing from control group (4 due to adverse effects). |
Selective reporting (reporting bias) | High risk | Standard deviations (SDs) of endpoint / change score for depression were not reported. |