Dam 1996a.

Study characteristics
Methods	Study design: parallel design Number of arms: 2 Experimental arm: fluoxetine (SSRI) Control arm: matched placebo
Participants	Geographical location: Italy Setting: unclear Stroke criteria: ischaemic, unilateral MCA territory stroke Method of stroke diagnosis: via clinical signs and CT (100%) Time since stroke: 1 to 6 months prior to randomisation (average time 3 months) Inclusion criteria: 1) unable to walk Exclusion criteria: 1) history of major affective disorders; 2) alcohol abuse; 3) a history or evidence or both of severe heart, lung, kidney or liver diseases or mental deterioration Total number randomised in this study: 26 Number randomised to treatment group: 18 (44% men, mean age 68 years, SD 9) Number randomised to control group: 8* (44% men, mean age 68 years, SD 6) Total number included in final analysis: 24 Number included in treatment group for final analysis: 16 Number included in control group for final analysis: 8*
Interventions	Treatment: fluoxetine (SSRI), 20 mg daily Control: matched placebo Treatment duration: treatment continued on average 74 +/‐ 6 days, duration not reported for control group Follow‐up: not reported
Outcomes	Primary outcomes Depression measured using the HDRS Secondary outcomes Impairment measured using the Hemispheric Stroke Scale (HSS) Disability measured using the BI Leaving the study early Adverse events Death
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Patients were randomly divided into three groups and treated for 3 months with physical therapy associated with ..." pp. 2 Comments: method of sequence generation not reported
Allocation concealment (selection bias)	Unclear risk	Comments: method of allocation not reported
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comments: blinding of participants and personnel was not reported
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The examining neurologists were blinded to the treatment administered to the patients." pp. 2
Incomplete outcome data (attrition bias) All outcomes	High risk	Comments: per protocol analyses reported only. 3/35 participants were not included in the analysis
Selective reporting (reporting bias)	Unclear risk	Comments: no trial protocol available to compare with the publication
Other bias	Low risk	Comments: there was no statistically significant difference between the treatment and control group in baseline demographic characteristics