Fisch 2003.

Methods	Randomised, placebo‐controlled, multicentre (15 centres) study
Participants	Ambulatory people of either sexes with advanced cancer (mixed sites) and depressive symptoms, as assessed with a score of 2 or greater on the Two‐Question Screening Survey (TQSS), excluding people with major depression diagnosed by a psychiatrist in the past 6 months. All participants gave informed consent
Interventions	Fluoxetine: 83 participants. The dose was 20 mg/day, fixed Placebo: 80 participants
Outcomes	The primary outcome was the quality of life (QoL) assessed with the Functional Assessment of Cancer Therapy–General (FACT‐G, version 3). The secondary outcome was the depressive symptoms assessed with the 11‐item BZSDS.
Notes	None
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "[...] randomly assigned in a double‐blind manner to receive either fluoxetine (20‐mg tablets) or an identical placebo tablet. The randomisation was performed centrally through a preprinted randomisation table, and the study drug was sent by overnight mail directly to the patient" and "Patients in each study arm were comparable at baseline with respect to age, sex, performance status, symptom status regarding pain and depression, disease distribution, and current treatment with chemotherapy."
Allocation concealment (selection bias)	Low risk	Quote: "[...] The randomisation was performed centrally through a preprinted randomisation table, and the study drug was sent by overnight mail directly to the patient."
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "Patients were then randomly assigned in a double‐blind manner to receive either fluoxetine (20‐mg tablets) or an identical placebo tablet". This should ensure patient blinding. The study is described as 'double‐blind', however procedures for ensuring the blinding of who administered the intervention are not discussed.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not discussed
Incomplete outcome data (attrition bias) All outcomes	High risk	Only participants who completed the assessment at each time point were analysed and missing data were not imputed ('per protocol' analysis). At the 'primary endpoint' (second visit, mean of 4.6 (fluoxetine group) versus 4.7 (placebo group) weeks from baseline) 64 versus 65 participants were assessed (over 83 versus 80 participants randomised). Only dropout rates due to side effects at the end of the study are reported, and whether there was imbalance between groups in term of reasons for leaving the study early is not discussed.
Selective reporting (reporting bias)	Low risk	Relevant data for the pre‐specified (methods) outcomes are reported (results).
Other bias	Unclear risk	Sponsorship bias cannot be ruled out since a 'financial disclosure' or possible conflicts of interest are not reported.