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. 2019 Nov 26;2019(11):CD009286. doi: 10.1002/14651858.CD009286.pub3

Robinson 2000a.

Methods Parallel design
Comparison of fluoxetine, nortriptyline and placebo. We are using the fluoxetine and placebo data
Analysis: per protocol, number excluded from analyses varied
Data provided for depressed and non‐depressed separately. We are labelling the depressed group as Robinson 2000a (this trial), and the non‐depressed group as Robinson 2000b
Participants Location: USA and Argentina
Setting: mixed
Treatment: 23 people with depression, mean ± SD age 65 ± 14 years; 17 men
Control: 17 people with depression, mean ± SD age 73 ± 10 years; 9 men
Stroke criteria: all subtypes, diagnosis by clinical signs and CT (100%), stroke within 6 months of recruitment, 18 to 85 years of age
Stroke on average 16 weeks (fluoxetine) and 6 weeks (placebo) prior to randomisation
Exclusion criteria: other significant medical illness, severe comprehension deficit, prior history of head injury, prior history of other brain disease (with the exception of stroke), participants on antidepressants (other than fluoxetine) were allowed to stop their antidepressant for a 2‐week washout period
Interventions Treatment: fluoxetine 10 mg daily (3 weeks), 20 mg daily (3 weeks), 30 mg daily (3 weeks), 40 mg daily (3 weeks)
Control: matched placebo
Duration: treatment continued for 12 weeks
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
Additional: MMSE, JHFI
Death
AEs (method of reporting these was not stated)
Funding source Funded by NIMH grants and grants from the Raul Carrea Institute of Neurological Research and Fundacion Perez Companc. Eli Lilly and company supplied the fluoxetine and placebo
Notes Note difference in time since stroke between treatment groups
Dates of recruitment not stated. Conflicts not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random‐number table
Allocation concealment (selection bias) Low risk Concealment held by independent person
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 Per‐protocol and ITT analyses
Selective reporting (reporting bias) Low risk Protocol published www.strokecentre.org/trials
Other bias Unclear risk Imbalance in treatment groups for time since stroke and gender