Rahman 1991.
Methods | Six‐week double blind, multicentre, randomised study. | |
Participants | Patients meeting DSM‐III for major depressive episode, with a minimum baseline score of 29 on the MADRS. Age range: 61‐86 years old. Exclusion criteria: concurrent depressive delusions or stupor; depression secondary to other psychiatric illness, according to DSM‐III; narrow angle glaucoma; symptoms suggestive of prostatic hypertrophy; history of epilepsy, myocardial infarct within 3 months of entry into the study or any degree of heart block or other clinically significant arrhythmia. | |
Interventions | Fluvoxamine: 26 participants.
Dothiepin: 26 participants.
Fluvoxamine dose range: 100‐200 mg/day.
Dothiepin dose range: 100‐200 mg/day. Hypnotic and anxiolytic medication was allowed during the study, but other antidepressants were not. |
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Outcomes | MADRS, CGI‐I, Newcastle Scale. Total dropout, dropout due to side effects, number of patients experiencing at least one side effect. |
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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: 9/26 missing from fluvoxamine group (2 due to adverse effects); 7/26 missing from control group (2 due to adverse effects). |
Selective reporting (reporting bias) | High risk | SDs for endpoint score and change score were not reported. |