Karaiskos 2012.
Methods | Parallel randomised trial Method of randomisation: randomised stated, method unclear Method of concealment: open‐label Blinding: open‐label Analysis: no loss to follow‐up | |
Participants | Location: Greece
Setting: outpatients Number of participants: 60 participants at randomisation and all completed the study (mean age 53 years, sex unclear) Treatment group 1: 20 (mean age 51 years, sex unclear) Treatment group 2: 20 (mean age 54 years, sex unclear) Control group: 20 (mean age 52 years, sex unclear) Stroke criteria: ischaemic and haemorrhagic, based on clinical history, physical examination and brain MRI Time since stroke onset at randomisation: within 1 year after stroke Fatigue criteria: participants did not have to have fatigue at recruitment Other entry criteria: clinical diagnosis of depression, within 1 year after stroke Comparability of groups: no significant differences between groups at baseline in demographics, stroke characteristics and fatigue scores |
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Interventions | Treatment 1 intervention: oral duloxetine, 60 to 120 mg/day Treatment 2 intervention: oral citalopram, 20 to 40 mg/day Treatment 3 intervention: oral sertraline, 50 to 200 mg/day Treatment duration: 3 months Delivered by: unclear |
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Outcomes | Time for fatigue assessment: baseline, 1 month, 2 months and 3 months after the start of treatment Primary outcome: Hamilton Rating Scale for Depression, Hamilton Rating Scale for Anxiety Secondary outcome: FSS |
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Notes | Only people with post‐stroke depression were recruited Fatigue was measured as one of the symptoms of depression Funding: no information available |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | High risk | "Open‐label" trial, so participants and medical staff would be aware of what was being used |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not enough information reported |
Intention‐to‐treat | Low risk | No loss to follow‐up reported |