Chollet 2011.
| Methods | Randomised parallel‐group trial | |
| Participants | Location: France Setting: stroke units Inclusion criteria: aged 18 to 85 years with FMMS of 55 or less, acute ischaemic stroke with hemiparesis or hemiplegia, 5 to 10 days after stroke onset, unclear if there had to be a visible lesion on brain imaging Treatment: 59 people, mean ± SD age 66.4 ± 11.7 years; 63% men Control: 59 people, mean ± SD age 62.9 ± 13.4 years; 59% men Comparability of treatment groups: total FMMS score fluoxetine 17.1 compared with 13.4 in placebo Previous stroke more common in the fluoxetine group; fluoxetine group had more diabetes Exclusions: clinical depression or treatment with antidepressants, MADRS > 19, aphasia severe enough to mask detection/assessment of depression, pregnancy, patient on neuroleptics/benzodiazepines, owing to undergo carotid endarterectomy, other major diseases that would prevent follow‐up |
|
| Interventions | Treatment: fluoxetine 20 mg daily for 90 days Control: identical capsules to active drug Duration of treatment: 90 days Duration of follow‐up (treatment end to study end): 0 days |
|
| Outcomes | Primary outcome: the mean change of FMMS score between inclusion (day 0) and day 90 after the start of the study drug Secondary endpoints were NIHSS, mRS and MADRS measured at days 0, 30 and 90 |
|
| Funding source | Funded by French national programme for clinical research: the sponsor had no involvement in study design, data collection, data analysis, data interpretation or writing the report | |
| Notes | Recruitment 14 March 2005 to 9 June 2009. Authors state "no conflicts of interest" | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Balanced by centre with an allocation based on a block size of 4 generated with a computer random‐number generator |
| Allocation concealment (selection bias) | Low risk | Sequentially‐numbered opaque envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Identical capsules for control arm |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | All study site investigators and all investigators were masked to treatment allocation |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropouts: 2 participants died (1 in each group) and 3 dropped out ‐ not stated how missing outcome data were dealt with |
| Selective reporting (reporting bias) | Low risk | Trial protocol published on www.strokecentre.org/trials, all outcomes were reported |
| Other bias | Unclear risk | Note difference in baseline: it is not clear what effect this had on results, so we have classified this as 'unclear risk' |