SBK‐115 1998.

Methods	Twelve‐week, randomised, double‐blind, comparative, placebo‐controlled study.
Participants	Outpatients >18 years old with moderate to moderately severe depression (DSM: single episode or recurrent). At both the screen visit and baseline the Hamilton rating scale for depression (HDRS‐21) had to be at least 18 for the HDRS‐21 first 17 items; the could not decrease by more than 25% between screen and baseline visit. The Raskin depression score had to be at least 8 at baseline and must have exceeded the Covi Anxiety Score (CAS). Key exclusion criteria were patients with a primary psychiatric diagnosis other than depression, or those with serious concomitant diseases. Patients were excluded who had a serious suicidal threat, recent ECT or with substance abuse.
Interventions	Paroxetine:287 participants. Fluoxetine: 289 participants. Paroxetine dose range: 20‐50 mg/day. Fluoxetine dose range: 20‐80 mg/day.
Outcomes	HDRS, Clinical Global Impression (CGI), the Raskin Depression score (RDS), CAS. 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: "subjects were 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". No further details.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "double blind". No further details.
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "analyses were performed on the Intention‐to‐treat (ITT) population, which included all subjects who were randomized to study medication. For the safety analysis, this included the total patient population. The efficacy ITT population (depression, anxiety) only included all randomized patients with at least one on‐therapy efficacy evaluation". More than 20% of participants in both arms abandoned the study prematurely.
Selective reporting (reporting bias)	Low risk	Outcomes data were reported.
Other bias	Unclear risk	Sponsorship bias cannot be ruled out.