Wiart 2000.
| Study characteristics | ||
| Methods | Purpose: to treat early depression Parallel design Analysis: ITT (last observation carried forward), withdrawn owing to AE (1 treatment), protocol violation (1 treatment) |
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| Participants | Location: France Setting: unclear Treatment: 16 people, mean ± SD age 66 ± 7 years, 65% men Control: 15 people, mean ± SD age 66 ± 12 years, 40% men Stroke criteria: ischaemic stroke and PICH, diagnosis by clinical signs and CT (100%); stroke on average 47 ± 22 days (treatment group) and 48 ± 20 days (control group) Depression criteria: psychiatric interview (ICD‐10 criteria) and MADRS score > 19 Other entry criteria: all antidepressant or neuroleptic drugs stopped 10 days prior to enrolment Comparability of treatment groups: balanced Exclusion criteria: severe psychiatric problems which required hospitalisation, severe aphasia, previous stroke, severe cognitive impairment, chronic alcoholism, chronic associated handicapping pathology, contraindication to fluoxetine |
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| Interventions | Treatment: fluoxetine 20 mg daily Control: matched placebo Duration of treatment: 45 days Duration of follow‐up (treatment end to study end): 0 |
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| Outcomes | Depression: change in scores from baseline to end of treatment of MADRS, 50% reduction in MADRS score Additional: FIMs MMSE Motricity Index Leaving the study early Death AEs ("evaluated qualitatively and quantitatively". Complete blood count, liver test and renal function test were carried out at each assessment visit) |
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| Funding source | Lilly France Laboratory provided methodological and financial support | |
| Notes | Dates of recruitment not stated. Conflicts of interest not stated | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of randomisation not stated |
| Allocation concealment (selection bias) | Unclear risk | Method not stated |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Identical white capsules" given |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Method of blinding not stated |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Used last observation carried forward; 2/31 (both in fluoxetine group) dropped out. This is > 5% |
| Selective reporting (reporting bias) | Low risk | Trial published on www.strokecentre.org/trials. The primary outcome was reported |
| Other bias | Unclear risk | Baseline balanced |