Andersen 1994.
Study characteristics | ||
Methods | Parallel design Analysis (ITT) last observation carried forward and per protocol: death (1 treatment, 1 control) withdrawn owing to AE (6 treatment, 1 control), all excluded from analysis |
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Participants | Location: Denmark Setting: mixed Treatment: 33 people, mean ± SD age 68 ± 4 years, 36% men Control: 33 people, mean ± SD age 66 ± 9 years, 66% men Stroke criteria: ischaemic stroke and PICH; diagnosis via clinical signs and CT (100%); stroke 2 to 52 weeks prior to randomisation (average time 12 weeks) Depression criteria: HDRS score > 12 (score transformed to appropriate DSM‐III‐R criteria) Other entry criteria: none stated Comparability of treatment groups: balanced Exclusion criteria: depression within last year, receiving current treatment for depression, severe dementia or communication problems, degenerative or expansive neurological disease, decreased consciousness |
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Interventions | Experimental: citalopram 10 mg in participants > 66 years, 20 mg in participants < 67 years daily; dose doubled if no response to treatment within 3 weeks Comparator: matched placebo Duration: treatment continued for 6 weeks Duration of follow‐up (post‐treatment to study end): 0 Note that although the protocol on www.strokecentre.org/trials states that mood scores were measured up to 1 year post‐stroke, this probably refers to the time since stroke at the time of randomisation |
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Outcomes | Depression: change in scores from baseline to end of treatment on HDRS Melancholia scale Proportion no longer meeting entry criteria (< 13 on HDRS) 50% reduction in HDRS score Additional: leaving the study early Death AEs (unwanted drug effects were registered and evaluated at the same intervals using a side effect scale) Unable to use: BI, Social Activities Index, MMSE (data not presented) |
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Funding source | Funded by Lundbeck Foundation, Medical Research Foundation for North Jutland County, The Aalgorg Diocese Research Foundation, Consultant Otorhinolaryngologist Kopp's Foundation and Stine and Martinus Sorensen's Foundation. Lundbeck Pharma A/S provided the citalopram and placebo; thus we have classified this as 'unclear risk'. | |
Notes | Recruitment 1 February 1991 to 29 February 1992. Conflicts of interest not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Blocks of 4 used |
Allocation concealment (selection bias) | Low risk | Centralised opaque envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Matched placebo |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Those who were blinded were not stated |
Incomplete outcome data (attrition bias) All outcomes | High risk | Although there were dropouts, analysis performed both per protocol and using last observation carried forward |
Selective reporting (reporting bias) | High risk | Trial published on www.strokecentre.org/trials The primary outcome was reported. We have been unable to access this record on 28 September 2021, the paper also describes the social activities index in the list of outcomes but this was not reported in the results so we have changed this to high risk of bias for this 2021 update |
Other bias | Unclear risk | − |