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 |
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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 |
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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 |
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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 |
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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 |
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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 |