Dam 1996.
| Methods | Parallel design Analysis: per protocol: withdrawn because of AEs (2 treatment), all excluded from analysis |
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| Participants | Location: Italy Setting: unclear Treatment: 18 people, mean ± SD age 68 ± 9 years, 44% men Control: 17 people, mean ± SD age 68 ± 5.5 years, 44% men Stroke criteria: ischaemic, unilateral MCA territory stroke, diagnosis via clinical signs and CT (100%), stroke 1 to 6 months prior to randomisation (average time 3 months) Other inclusion criteria: unable to walk Comparability of treatment groups: balanced Exclusion: history of major affective disorders; alcohol abuse; or a history or evidence or both of severe heart, lung, kidney or liver diseases or mental deterioration |
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| Interventions | Treatment: fluoxetine 20 mg daily Control: matched placebo Duration: treatment continued on average 74 ± 6 days, duration not reported for control group 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 on HDRS Additional: graded neurological scale (HSS), BI Leaving the study early Death AEs including seizures ‐ unclear if these were reported systematically |
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| Funding source | Funding source not stated | |
| Notes | Dates of recruitment and conflicts of interest not stated | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No description |
| Allocation concealment (selection bias) | Unclear risk | No description |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Examining neurologists blind to treatment". Comment: Unclear if this refers to outcome assessors or the neurologist caring for the participant. However, placebo was 'matched' so this is low risk |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | See above |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 2/35 dropouts, per‐protocol analysis |
| Selective reporting (reporting bias) | Low risk | Trial available, including results on www.strokecentre.org/trials ‐ all specified outcome measures were reported |
| Other bias | Unclear risk | Baseline characteristics similar in the 2 groups |