Roh 1996.

Study characteristics
Methods	Study design: parallel design Number of arms: 2 Experimental arm: indeloxazine (tricyclic agent) Control arm: matched placebo
Participants	Geographical location: Korea Setting: unclear Stroke criteria: ischaemic stroke Method of stroke diagnosis: via clinical signs and symptoms and CT (100%) Time since stroke: unclear Inclusion criteria: 1) mental and neurological symptoms for 1 to 3 months attributed to cerebral infarction Exclusion criteria: 1) Alzheimers disease; 2) unstable patients (stroke occurring within 1 month); 3) disturbance of consciousness; 4) severe dementia (MMSE < 20); 5) unable to communicate adequately with investigator; 6) advanced hepatic, renal or cardiac circulatory impairment; 7) pregnancy, possibility of becoming pregnant; 8) under 20 years of age; 9) those judged unsuitable for participation by investigators Total number randomised in this study: 65 Number randomised to treatment group: 32 (90% men, mean age unclear) Number randomised to control group: 33 (87% men, mean age unclear) Total number included in final analysis: 60 Number included in treatment group for final analysis: 30 Number included in control group for final analysis: 30
Interventions	Treatment: indeloxazine (tricyclic agent), 20 mg daily Control: matched placebo Treatment duration: continued for 3 months Follow‐up: not reported
Outcomes	Primary outcome Depression measured using the physician assessment of change in emotional disturbance from baseline to end of treatment
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Patients were assigned by using a table of random numbers to receive either 20 mg of indeloxazine or placebo three times daily, after meals, for 3 months." pp. 633
Allocation concealment (selection bias)	Low risk	Quote: "The placebo and test drug were given in identical tablet form to ensure double‐masking." pp. 633‐4
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "The placebo and test drug were given in identical tablet form to ensure double‐masking." pp. 633‐4
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The placebo and test drug were given in identical tablet form to ensure double‐masking." pp. 633‐4
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "Of the 33 patients in the placebo group, 2 patients complained of headache and 1 showed a deterioration in eyesight: these patients withdrew from the study and were not included in the analysis." pp. 636‐7
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