Kiev 1997.

Methods	Seven‐week double blind, multicentre, randomised study.
Participants	Psychiatric outpatients meeting DSM‐III‐R for recurrent major depressive disorder, with a minimum baseline score of 20 on the HRSD‐21. Age range: 18‐65 years old. Exclusion criteria: woman of childbearing potential were required to use appropriate birth control methods, and no pregnant or nursing patients were included the study; patients who were not fluent in written or oral English; had a history of medication noncompliance or substance abuse within the previous 6 months (other than nicotine); had been treated within 30 days with a drug with anticipated major organ toxicity; had a severe risk of suicide or displayed auto‐aggressive behavior during the current depressive episode; hypersensitivity to SSRIs; participation in previous fluvoxamine studies; significant organic disease; clinically significant laboratory abnormalities; other primary psychiatric diagnoses; patients who would not be able to return for assessment due to transportation difficulties.
Interventions	Fluvoxamine: 30 participants. Paroxetine: 30 participants. Fluvoxamine dose range: 50‐150 mg/day. Paroxetine dose range: 20‐50 mg/day. Sufficient washout from other investigational drugs prior psychotropic drugs, and ECT was assured, and concomitant use of any psychotropic medication was prohibited. While medications to treat gastrointestinal disturbances (antacids, laxatives), and headache (acetaminophen, aspirin, ibuprofen) and to provide nighttime sedation (chloral hydrate only) were permitted, all other medication use was prohibited unless approved by the study physician.
Outcomes	HRSD‐21, CGI‐I, CGI‐S, HRSA, SCL‐56. Total dropout, dropout due to inefficiency, 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
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	Quote: "double blind", no further details.
Incomplete outcome data (attrition bias) All outcomes	High risk	Study endpoint: 11/30 missing from fluvoxamine group (1 due to lack of efficacy, 2 due to adverse effects); 9/30 missing from control group (3 due to lack of efficacy, 5 due to adverse effects).
Selective reporting (reporting bias)	High risk	SDs of endpoint score for depression were not reported.