Palomaki 1999.

Study characteristics
Methods	Study design: parallel design Number of arms: 2 Experimental arm: mianserin (tetracyclic agent) Control arm: matched placebo
Participants	Geographical location: Finland Setting: unclear Stroke criteria: ischaemic stroke Method of stroke diagnosis: via clinical signs and CT or MRI (100%) Time since stroke: 0 to 30 days prior to randomisation (average 14.3 days) Inclusion criteria: 1) under 71 years of age Exclusion criteria: 1) other diseases severe enough to confound the assessments of stroke outcome (severe cardiovascular, renal or liver disease, psychosis, alcoholism or dementia); 2) currently on antidepressants Total number randomised in this study: 100 Number randomised to treatment group: 51 (71% men, mean age 56 years, SD 11) Number randomised to control group: 49 (65% men, mean age 55 years, SD 10) Total number included in final analysis: 64 Number included in treatment group for final analysis: 27 Number included in control group for final analysis: 37
Interventions	Treatment: mianserin (tetracyclic agent),10 mg every night; within 10 days dosage increased to 60 mg daily Control: matched placebo Treatment duration: treatment continued for 12 months Follow‐up: 18 months
Outcomes	Primary outcomes Depression (proportion not meeting criteria for major depression) measured using the DSM‐III‐R Depression (change in scores from baseline to end of treatment) measured using the HDRS and the BDI Secondary outcomes Adverse events
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "The patients were randomized to mianserin or placebo groups of equal size, stratified according to location of lesion ..." pp. 490 Comments: method of sequence generation not reported
Allocation concealment (selection bias)	High risk	Quote: "The randomization codes were kept in sealed envelopes." pp. 491 Comments: this method of concealment can be tampered with
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "For each stratum, the test drugs were provided in numbered vials containing tablets of identical appearance." pp. 491
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comments: blinding of outcome assessment not reported
Incomplete outcome data (attrition bias) All outcomes	High risk	Comments: per protocol analysis reported only. Only 75% of participants remained in placebo and 52% remained in treatment group at 12 months and were included in the analysis
Selective reporting (reporting bias)	Unclear risk	Comments: no trial protocol available to compare with the publication
Other bias	Unclear risk	Comments: the treatment group had more heart disease