Ontiveros 1994.

Methods	Randomised, double‐blind, parallel‐group study.
Participants	Male and female participants, aged 18 to 75 years inclusive, who were suffering from a major depressive episode according to the DSM‐III criteria, with a diagnosis confirmed by observation of signs and symptoms, and a score >18 on the Hamilton rating scale for depression (HDRS) scale at the pretreatment and baseline assessment. Participants with severe co‐existing disease, who had received ECT therapy in the previous 3 months, IMAO in the previous 2 weeks, lithium in the previous 3 months, oral neuroleptics in the previous 2 weeks, depot neuroleptics in the previous 4 weeks, benzodiazepines in the previous 3 days or coadministration of any drug with know psychotropic effects, participants at severe risk of suicide were excluded from the study.
Interventions	Paroxetine: 60 participants. Fluoxetine: 62 participants. Paroxetine dose: 20 mg/day. Fluoxetine dose: 20 mg/day.
Outcomes	HDRS, Clinical Global Impression (CGI). Total dropout, dropout due to side effects, dropout due to inefficacy. Number of patients experiencing at least one side effect, side‐effect profile.
Notes	Funding: paroxetine manufacturer.
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 information provided.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "double blind (...) in order to maintain the blind, all medication was concealed in coloured capsules".
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "double blind".
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "the primary analyses were performed on the Intention‐to‐treat (ITT) population, which included all subjects who were randomized to active treatment and had at least one valid efficacy evaluation after the start of treatment". The primary dataset was the ITT endpoint assessment (defined as the patient's last available assessment between weeks 4 and 6). Less than 20% of participants withdrew from the study prematurely.
Selective reporting (reporting bias)	High risk	Only adverse events by more than 5% of participants were reported.
Other bias	Unclear risk	Sponsorship bias cannot be ruled out.