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. 2021 Nov 15;2021(11):CD009286. doi: 10.1002/14651858.CD009286.pub4

Robinson 2008.

Study characteristics
Methods Parallel group, 3‐arm (escitalopram, placebo, problem‐solving therapy group). We are using the escitalopram versus placebo arm in this review
Analysis: ITT
Participants Country: USA
Setting: mixed: neurology department and newspaper advertisements
Stroke criteria: ischaemic or haemorrhagic stroke not because of complications of intracranial aneurysm or intracranial vascular malformation; within 3 months of index stroke
Mood: excluded if DSM IV for major or minor depression or HAMD > 17
Treatment (escitalopram): 59 people, mean ± SD age 61.2 ± 13.7, 38 men
Control (matched placebo): 58 people, mean ± SD age 63.9 ± 11.1, 37 men
Exclusion: acute coronary syndrome, neurodegenerative disorders, DSM IV criteria for alcohol or substance abuse
Interventions Treatment: escitalopram 5 mg to 10 mg (depending on age ‐ lower dose given to > 65 years old)
Control: matched placebo
Duration of treatment: 12 months
Duration of follow‐up (treatment end to study end): 0
Outcomes Diagnosis of depression
HAMD (dichotomised)
FIM (though no raw data provided in the paper for meta‐analysis)
Social functioning examination
Repeatable Battery for Neuropyschological Status
The Iowa subset provided detailed information about cognition
Participants, family members and primary care physicians were asked about AEs at 3 monthly intervals or sooner if an individual reported an AE using a standardised checklist
Funding source The initial report states that "This work was supported solely by National Institute of Mental Health Grant RO1MH‐65134. All the study medications were purchased using NIMH grant funds." In a subsequent letter to the Journal, the authors disclosed honoraria and expenses from pharmaceutical companies, and that 1 of the authors owned Pfizer stock. However, the authors stated that the design and analysis of any of the expenses of the study were supported by monies, materials or any intellectual input from Forest Laboratories
Notes The escitalopram group had significantly more diabetes than the placebo group
Financial disclosures: see above
Recruitment: 9 July 2003 to 1 October 2007
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised blocks of 3, 6, and 9
Allocation concealment (selection bias) Unclear risk Not described
Blinding of participants and personnel (performance bias)
All outcomes Low risk Identical placebo
Blinding of outcome assessment (detection bias)
All outcomes Low risk Outcome assessors were blinded
Incomplete outcome data (attrition bias)
All outcomes Low risk ITT analyses, all participants used in analysis
Dropouts: 5 in placebo and 7 drop‐outs in escitalopram
Selective reporting (reporting bias) Low risk All specified outcome data reported. Trial published on www.strokecentre.org/trials
Other bias Unclear risk There was more diabetes in the escitalopram group than placebo group