Dam 1996.
| Study characteristics | ||
| Methods | Parallel design Analysis: per protocol: withdrawn because of AEs (2 treatment), all excluded from analysis |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 as the treating physician and the participants would have been blind |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | See above |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 2/35 dropouts (5.7%), 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 | Low risk | Baseline characteristics similar in the 2 groups |