Perez 1990.
Methods | Six‐week double blind, multicentre, randomised study. | |
Participants | Psychiatric outpatients meeting DSM‐III for major depressive episode, with a minimum baseline score of 30 on the MADRS. Age range: 18 years old or more; mean 41.6 years old. Exclusion criteria: pregnant or at risk of becoming pregnant, breast feeding; strong suicide potential; major physical disorders such as epilepsy, hepatic or renal disease. | |
Interventions | Fluvoxamine: 30 participants.
Mianserin: 33 participants.
Fluvoxamine dose range: 100‐300 mg/day
Mianserin dose range: 60‐180 mg/day. No other form of antidepressant medication was allowed during the trial period. |
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Outcomes | MADRS, CGI‐I, Leeds Sleep Evaluation Questionnaire. Total dropout, dropout due to inefficiency, dropout 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 | Unclear. | |
Notes | Patients with major depressive episode (DSM‐III) 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: "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 | High risk | Study endpoint: 9/30 missing from fluvoxamine group (1 due to lack of efficacy, 6 due to adverse effects); 9/33 missing from control group (2 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. |