Dalery 2003.

Methods	Six‐week double blind, multicentre, randomised study.
Participants	Psychiatric outpatients meeting DSM‐III‐R for major depressive episode, with a minimum baseline score of 17 on the HRSD‐17. Age range: 18‐70 years old. Exclusion criteria: acute suicidal ideation or a serious suicide attempt in the previous 6 months; dementia; a history of epilepsy or seizures; concurrent or recent (6 months) alcoholism, other psychoactive substance abuse or drug‐induced psychosis, were pregnant, lactating or of childbearing potential and not taking adequate contraceptive measures, or if they had clinically uncontrolled hepatic, renal, pulmonary, endocrine or collagen disease. Also excluded were patients who had previously failed SSRI therapy or who required concomitant lithium, warfarin, hepatically metabolised antivitamine K agents, carbamazepine, theophyline, insulin or hypoglycaemic agents. Patients were required not to receive monoamine oxidase inhibitors or ECT in the 2 weeks prior to the study.
Interventions	Fluvoxamine: 90 participants. Fluoxetine: 94 participants. Fluvoxamine dose: 100 mg/day. Fluoxetine dose: 20 mg/day. Oxazepam or nitrazepam were permitted as necessary for night time sedation; no other psychotherapeutic treatments or ECT were permitted during the study.
Outcomes	HRSD‐17, CGI‐I, CGI‐S, Clinical Anxiety Scale, Irritability, Depression and Anxiety scale, Beck's scale for suicide ideation score. Total dropout, 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: "randomised", 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: 24/90 missing from fluvoxamine group; 20/94 missing from control group (due to lack of efficacy, due to adverse effects).
Selective reporting (reporting bias)	High risk	SDs of endpoint/change score for depression were not reported.