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. 2021 Mar 5;2021(3):CD011246. doi: 10.1002/14651858.CD011246.pub2

Rasmussen 2003.

Study characteristics
Methods Study design: randomised (2‐arm parallel randomised controlled clinical trial)
Sample size: 155
Method of randomisation: division in terms of gender and age (over and under 65 years of age)
Method of concealment: no information specified
Blinding: double‐blind
Analysis: no information specified
Date the study was conducted: January 1996 ‐ May 1998
Participants Location: Denmark
Total N randomised: 137
Intervention n: 70 (50 % male; age M = 72, SD = 9)
Control n: 67 (51 % male; age M = 68, SD = 11)
Inclusion criteria: stroke in the preceding 4 weeks
Diagnostic criteria ‐ long‐term physical condition: stroke is diagnosed according to clinical criteria (WHO)
Diagnostic criteria ‐ depression: diagnosis of depression according to ICD‐10 and assessed by clinical interview
Exclusion criteria: current depression (total score > 13 on the HAM‐D‐17); stroke occurrence not within the preceding four weeks; significant aphasia; use of antidepressants (within the preceding 4 weeks); dementia; history of schizophrenia, psychosis, or severe drug abuse; present preexisting neurological illness; cardiovascular illness (within preceding 6 months)
History of depression: no information specified
Interventions Intervention: daily dose of 50 mg sertraline (in case of clinical need, dosage is flexibly increased up to a maximum dose of 150 mg/day)
Control: matched placebo
Duration of treatment: 12 months
Length of follow‐up: 12 months (at baseline, and 11 post‐randomisation visits (occurring at approximately 4‐5 week intervals)
Other study arms: no
Outcomes Primary outcome:

  • incidence of depression ‐ diagnosis: N/A

  • adverse events: total numbers of adverse events measured by the UKU Side Effect Rating Scale


Secondary outcome:

  • incidence of depression ‐ cut‐off:

    • HAM‐D (modified 17‐item version with item 14 sexual behaviour not rated) cut‐off score > 18 (at baseline, 3, 6 and 11 months);

    • HAM‐D (6‐item version) cut‐off score ≥ 9 (at baseline, 3, 6 and 11 months);

    • GDS cut‐off score > 16 (at baseline and all post‐randomisation visits)


(Note: due to the predefined hierarchy of outcome measures we used data from the HAM‐D 17‐item version when reporting the incidence of depression.)

  • severity of depression: Newcasatle II scale (at baseline, 2, and 4 months) but not reported

  • cost‐effectiveness: N/A

  • cost‐utility: N/A
Notes Language: English
Funding: Pfizer A/S, Gert Jørgensen legat, and the Brain Cause (Hjernesagen)
Declaration of interest: no information specified
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "patients were fairly evenly divided in terms of gender and those over versus under 65 years of age..." (p. 218)
Allocation concealment (selection bias) Unclear risk no information specified
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk no information specified except for headline and p. 217 saying "...double‐blind ..."
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk no information specified except for headline and p. 217 saying "...double‐blind ..."
Incomplete outcome data (attrition bias)
All outcomes High risk numbers randomised: sertraline: n = 70; placebo: n = 67; total: N = 137
number of drop‐outs at 12 months: sertraline: n = 9; placebo: n = 10; total: N = 19
numbers analysed post‐intervention: sertraline: n = 61; placebo: n = 57; total: N = 118
reasons for drop‐out: no information specified
Selective reporting (reporting bias) High risk no protocol available but not all outcomes were reported, e.g. Newastle II scale
Other bias Low risk no