Zohar 2003.

Methods	Eight‐week double blind, multicentre, randomised study.
Participants	Psychiatric inpatients suffering from major depressive episode, with or without mood congruent psychotic features not requiring antipsychotic treatment according to DSM‐IV, with a minimum baseline score of 25 on the HRSD‐17. Age range: 18‐70 years old. Exclusion criteria: psychosis, a history of other psychiatric diagnosis; epilepsy or seizures; severe suicide risk; pregnant, lactating or of childbearing potential and not taking adequate contraceptive measures; clinically relevant/unstable disease which could affect the diagnosis and/or treatment of depression; hepatic or renal disease, severe heart disease, glaucoma, adrenal tumor, micturition disturbances, prostate hypertrophy; clinically relevant laboratory test abnormalities; multiple drug allergies; had been treated unsuccessfully with 2 or more antidepressants during the current episode of depression; had been treated with fluvoxamine or clomipramine during the current episode of depression.
Interventions	Fluvoxamine: 44 participants. Clomipramine: 42 participants. Fluvoxamine dose range: 100‐250 mg/day. Clomipramine dose range: 100‐250 mg/day. Patients were required not to have received any antidepressants in the week prior to active treatment (5 weeks in the case of fluoxetine) or lithium, monoamine oxidase inhibitors, antipsychotics or ECT in the 2 weeks prior to active treatment. With the exception of oxazepam, which could be given for night‐time sedation or control of anxiety, no other psychopharmacological treatments or ECT were permitted during the study.
Outcomes	HRSD‐17, MADRS, CGI‐I, CGI‐S. 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 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: "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: 10/44 missing from fluvoxamine group (1 due to lack of efficacy, 5 due to adverse effects); 13/42 missing from control group (10 due to adverse effects).
Selective reporting (reporting bias)	High risk	SDs of endpoint/change score for depression were not reported.