Rapaport 1996.
Methods | Seven‐week double blind, multicentre, randomised study. | |
Participants | Psychiatric outpatients meeting DSM‐III‐R for major depressive episode, with a minimum baseline score of 20 on the HRSD‐21. Age range: 22‐61 years old. Exclusion criteria: pregnant or nursing patients; unstable medical conditions; other axis I diagnoses; acute suicidality; history of substance dependence within 6 months of the study; history of a seizure disorder; had been treated with either fluvoxamine or fluoxetine before enrolment. | |
Interventions | Fluvoxamine: 51 participants.
Fluoxetine: 49 participants.
Fluvoxamine dose range: 100‐150 mg/day.
Fluoxetine dose range: 20‐80 mg/day. Only chloral hydrate (up to a maximum of 1000 mg/day) was allowed as adjuvant medication for insomnia during the study. |
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Outcomes | HRSD‐21, CGI‐I, CGI‐S, HRSA, Raskin‐Covi scale, SCL‐56. Total dropout, 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 fluvoxamine. | |
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: "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", "study medication was provided in identical‐appearing green capsules", no further details. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Study endpoint: 7/51 missing from fluvoxamine group (2 due to adverse effects); 8/49 missing from control group (2 due to adverse effects). |
Selective reporting (reporting bias) | High risk | SDs of endpoint/change score for depression were not reported. |