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. 2010 Mar 17;2010(3):CD006114. doi: 10.1002/14651858.CD006114.pub2

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.
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.
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.