Rossini 2005.

Methods	Seven‐week double blind, single‐centre, randomised study.
Participants	Psychiatric inpatients suffering from major depressive episode according to DSM‐IV, with a minimum baseline score of 22 on the HRSD‐21. Age range: 59 years old or more. Exclusion criteria: presence of any concomitant axis I diagnosis; presence of psychotic features together with somatic or neurological illnesses impairing psychiatric evaluation; mini mental state examination score less than 23.
Interventions	Fluvoxamine: 40 participants. Sertraline: 48 participants. Fluvoxamine dose: 200 mg/day. Sertraline dose: 150 mg/day. Subjects had not taken nonreversible monoamine oxidase inhibitors or slow release neuroleptics for at least 1 month before entering the study. All bipolar patients were under maintenance with mood stabilizers, the treatment remained unchanged during the present trial. No other psychotropic medication was allowed with the exception of flurazepam (up to 30 mg at bed time)
Outcomes	HRSD‐21. Total dropout, dropout due to inefficiency, dropout due to side effects, side effect profile.
Funded by pharmaceutical companies	Unclear.
Fluvoxamine as an investigational or comparator drug	As an investigational drug.
Notes	17/84 (17%) patients were with bipolar depression.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "randomization was performed by a computer originated schedule".
Allocation concealment (selection bias)	Unclear risk	No details.
Blinding (performance bias and detection bias) All outcomes	Low risk	Quote: "double blind", outcome assessors were blind to the treatment option.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Study endpoint: 1/40 missing from fluvoxamine group (1 due to adverse effects); 3/48 missing from control group (3 due to adverse effects).
Selective reporting (reporting bias)	High risk	SDs of change score for depression were not reported.