Kostiukova 2003.
Methods | Six‐week, single‐centre, randomised study. | |
Participants | Psychiatric inpatients meeting ICD‐10 for recurrent depressive disorder without psychotic features, with a minimum baseline score of 19 on the HRSD‐17. Age range: 18‐65 years old. Exclusion criteria: not stated. | |
Interventions | Fluvoxamine: 30 participants. Amitriptyline: 30 participants. Fluvoxamine dose range: 50‐300 mg/day. Amitriptyline dose range: 50‐250 mg/day. | |
Outcomes | HRSD‐17. Total dropout, dropout due to inefficiency, dropout due to side effects, side effect profile. |
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Funded by pharmaceutical companies | Unclear. | |
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 | No details. |
Allocation concealment (selection bias) | Unclear risk | No details. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | No details. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Study endpoint: 7/30 missing from fluvoxamine group (4 due to lack of efficacy, 3 due to adverse effects); 8/30 missing from control group (3 due to lack of efficacy, 5 due to adverse effects). |
Selective reporting (reporting bias) | High risk | SDs of endpoint/change score for depression were not reported. |