Ansseau 1994.
Methods | Six‐week double blind, multicentre, randomised study. | |
Participants | Psychiatric in‐ and outpatients meeting DSM‐III‐R for major depressive episode, with a minimum baseline score of 18 on the HRSD‐21. Age range: 18‐65 years old. Exclusion criteria: clinically significant co‐existing diseases or other psychiatric disorders, history of alcohol or drug abuse, women of child bearing potential not employing adequate contraception, recent treatment with monoamine oxidase inhibitors, neuroleptics, or lithium, and current treatment with oral anticoagulants and type 1C antiarrythmic. | |
Interventions | Fluvoxamine: 64 participants.
Paroxetine: 56 participants.
Fluvoxamine dose range: 50‐200 mg/day.
Paroxetine dose range: 20‐30 mg/day. For patients who had received benzodiazepines for at least two weeks prior to continue these agents, providing the dose remained unchanged throughout the study period. In addition, low dose lormethazepam or chloral hydrate were permitted in case of severe insomnia. |
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Outcomes | HRSD‐21, CGI‐S, Hamilton Rating Scale for Anxiety (HRSA). Total dropout, dropout due to inefficiency, dropout due to side effects, number of patients experiencing at least one side effect, side effect profile. |
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Funded by pharmaceutical companies | Funded by pharmaceutical company markets comparator drug. | |
Fluvoxamine as an investigational or comparator drug | Unclear. | |
Notes | Patients with major depressive episode (DSM‐III‐R) were included, so there might be some bipolar depression, but correct number was not reported. | |
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: "the trial used a double‐blind design", no further details. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Study endpoint: 23/64 missing from fluvoxamine group (5 due to lack of efficacy, 13 due to adverse effects); 16/56 missing from control group (2 due to lack of efficacy, 3 due to adverse effects). |
Selective reporting (reporting bias) | High risk | SDs of change score for depression were not reported. |