Ansseau 1991a.

Methods	Four‐week double blind, multicentre, randomised study.
Participants	Psychiatric inpatients meeting RDC for major depressive disorder, endogenous subtype, with a minimum baseline score of 25 on the Montgomery and Asberg Scale for Depression (MADRS). Age range: 20‐70 years old. Exclusion criteria: patients presenting any evidence of contra‐indications for a tricyclic antidepressant, or serious or uncontrolled medical illness.
Interventions	Fluvoxamine: 41 participants. Milnacipran: 42 participants. Fluvoxamine dose: 200 mg/day. Milnacipran dose: 300 mg/day for 2 weeks and 150mg/day during the 2 following weeks) The active period was preceded by a washout period of 4‐7 days on placebo and lorazepam (up to 10 mg/day) and nitrazepam (up to 10 mg/day) if needed. These associated drugs could be maintained during the treatment period if necessary.
Outcomes	HRSD‐24, CGI‐I, CGI‐S, CGI‐efficacy index, Raskin Scale for Depression. Total dropout, dropout due to inefficiency, dropout due to side effects, side effect profile.
Funded by pharmaceutical companies	Funded by pharmaceutical company markets comparator drug.
Fluvoxamine as an investigational or comparator drug	As a comparator drug.
Notes	11/127 (8.7%) patients were with bipolar depression and 14/127 (11.0%) patients were with psychotic features.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "randomly assigned", no further details.
Allocation concealment (selection bias)	Unclear risk	no details.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Both participants and drug prescribing physicians were blinded. No further details.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Study endpoint: 6/41 missing from fluvoxamine group (1 due to lack of efficacy, 5 due to adverse effects); 10/86 missing from control group (2 due to lack of efficacy, 7 due to adverse effects).
Selective reporting (reporting bias)	High risk	SDs of change score for depression were not reported.