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. 2021 Nov 15;2021(11):CD009286. doi: 10.1002/14651858.CD009286.pub4

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Analysis (ITT) last observation carried forward and per protocol: death (1 treatment, 1 control) withdrawn owing to AE (6 treatment, 1 control), all excluded from analysis
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
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
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)
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