Cassano 1986.

Methods	Four‐week double blind, multicentre, randomised study.
Participants	Psychiatric in‐ and outpatients meeting DSM‐III for major affective disorder, with a minimum baseline score of 15 on the HDRS‐17. Age range: 19‐70 years old. Exclusion criteria: child bearing potential or pregnant women; antidepressant therapy in the past 2 weeks; ECT within the last month; depressive symptoms secondary to other psychiatric illness; dependence upon licit or illicit drugs; serious organic diseases; need for concurrent medications which could interact with the study drugs or obscure their effects; patients unwilling or unable to cooperate with the study.
Interventions	Fluvoxamine: 169 participants. Imipramine: 161 participants. Placebo: 151 participants. Fluvoxamine dose range: 50‐300 mg/day. Imipramine dose range: 50‐300 mg/day. Chloral hydrate or flurazepam as hypnotics were allowed during the trial.
Outcomes	HDRS‐17, CGI‐I, CGI‐severity, BPRS, SCL‐90, SDS. Total dropout, dropout due to inefficiency, dropout due to side effects, side effect profile.
Funded by pharmaceutical companies	Funded by pharmaceutical company markets fluvoxamine.
Fluvoxamine as an investigational or comparator drug	As an investigational drug.
Notes	Patients with major affective disorder (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: 67/169 missing from fluvoxamine group (12 due to lack of efficacy, 19 due to adverse effects); 57/161 missing from control group (10 due to lack of efficacy, 17 due to adverse effects).
Selective reporting (reporting bias)	High risk	SDs of endpoint/change score for depression were not reported.