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 |
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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 |
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Outcomes | Primary outcomes
Secondary outcomes
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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 |