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. 2020 May 11;2020(5):CD003689. doi: 10.1002/14651858.CD003689.pub4

Robinson 2008.

Study characteristics
Methods Study design: parallel design
Number of arms: 2
Experimental arm: escitalopram (SSRI)
Control arm: matched placebo
Participants Geographical location: USA
Setting: outpatient
Stroke criteria: ischaemic or cerebellar stroke
Method of stroke diagnosis: based on clinical and neuro‐radiological findings consistent with either hemispheric, brainstem or cerebellar stroke
Time since stroke: not reported
Inclusion criteria: 1) patients with either ischaemic or cerebellar stroke
Exclusion criteria: 1) if they met DSM‐IV diagnostic criteria for major or minor (research criteria) depressive disorder; 2) those with severe comprehension deficit as demonstrated by inability to complete part 1 of the Token Test or patients with neuropsychological testing who showed impaired decision‐making capacity; 3) patients with acute coronary syndromes; 4) those with stroke as secondary complications from an intracranial aneurysm, arterial‐venous malformation, stroke from a myocardial infarction, aortic dissection or revascularization therapy; 5) life‐threatening heart or respiratory failure, renal or hepatic failure, severely disabling musculoskeletal disorder, cancer and neurodegenerative disorders such as idiopathic Parkinson disease or Alzheimer disease; 6) those who met the DSM‐IV criteria for alcohol or substance abuse or dependence within the past 12 months
Depression criteria: depression score not an entry criteria
Total number randomised in this trial: 117
Number randomised to treatment group: 59 (64.4% men, mean age 61.3, SD 13.7)
Number randomised to control group: 58 (63.8% men, mean age 63.9, SD 13.3)
Total number included in final analysis: 117
Number included in treatment group for final analysis: 59
Number included in control group for final analysis: 58
Interventions Treatment: escitalopram (SSRI) 10 mg/day (morning) for participants < 65 years and 5 mg/day for participants > 65 years
Control: matched placebo
Treatment duration: 12 months
Follow‐up: not reported
Outcomes Primary outcomes
  • Depression measured using the 17‐item HDRS


Secondary outcomes
  • Activities of daily living measured using the ADL Index

  • Social function measured using the Social Functioning Examination

Notes This trial had 3 arms (escitalopram, problem‐solving therapy and placebo) but only the data from the escitalopram group compared with placebo (n = 117 participants) are presented here
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "... each block patients were randomly assigned 1 of the 3 treatments using computer‐generated random numbers of 1, 2, or 3 to escitalopram." pp. 2393
Allocation concealment (selection bias) Low risk Quote: "all pills were identical ..." pp. 2393
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "all pills were identical ..." pp. 2393
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "Patients were seen for evaluation by raters who were blinded to drug assignment ..." pp. 2393
Incomplete outcome data (attrition bias)
All outcomes Low risk Comments: ITT analysis was reported. All participants were included in the analysis despite dropouts
Selective reporting (reporting bias) High risk Comments: did not report the results for anxiety
Other bias Low risk Quote: "There were no significant differences between the groups in age, sex, years of education, marital status, or socioeconomic status."
"There were no significant inter‐group differences in overall cumulative illness scores, coronary artery disease, low‐density lipoprotein cholesterol, atrial fibrillation, chronic obstructive pulmonary disease, or systolic blood pressure. The patients randomized to escitalopram, however, had a significantly greater frequency of diabetes mellitus when compared with the placebo group" pp. 2395