Rasmussen 2003.
| Methods | Parallel design Analysis: ITT (last observation carried forward) and per‐protocol: details of those excluded from analyses (35 treatment, 35 control) unclear |
|
| Participants | Location: Denmark Setting: unclear Treatment: 70 people, mean ± SD age 72 ± 9, 50% men Control: 67 people, mean ± SD age 68 ± 11, 51% men Stroke criteria: ischaemic and PICH; diagnosis by clinical signs and symptoms; stroke 0 to 4 weeks prior to randomisation Other entry criteria: not stated Comparability of treatment groups: participants in treatment group older on average |
|
| Interventions | Treatment: sertraline 50 mg daily; at any time after 2 weeks dose could be increased in 50 mg increments up to 150 mg daily; average dose 62.9 mg daily Control: matched placebo Duration of treatment: 12 months Duration of follow‐up (end of treatment to end of study): 0 |
|
| Outcomes | Depression: change in scores from baseline to end of treatment on HDRS Proportion scoring > 2 on the CGI or > 16 on the GDS at end of treatment Additional: leaving the study early. Did not report death Unable to use: HDRS, GDS, aphasia severity rating scale, European Stroke Scale, MMSE, Cambridge Cognitive Examination, SF‐36, BI (data not presented) AEs (detailed data not presented) evaluated by using the Udvalg for Kliniske Undersogelser Side Effect Rating Scale Did not report death |
|
| Funding source | Funding from Pfizer A/S, Gert Jorgensen legat and the Brain Cause. It is unclear whether the drug companies had input into the design and analysis of the study | |
| Notes | Recruitment January 1996 to May 1998. Conflicts not stated | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method not stated |
| Allocation concealment (selection bias) | Unclear risk | Method not stated |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Matched placebo |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Used ITT analysis and last observation carried forward |
| Selective reporting (reporting bias) | Low risk | Trial details published on www.strokecentre.org/trials |
| Other bias | Unclear risk | Those given sertraline were slightly older (by 4 years) but this is unlikely to introduce bias There was no significant difference between groups |