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

NCT00967408.

Methods Study type: interventional (clinical trial)
Estimated enrolment: 200 participants
Allocation: randomised
Intervention model: parallel assignment
Masking: quadruple (participant, care provider, investigator, outcomes assessor)
Primary purpose: treatment
Participants Country: Italy
Setting: inpatient
Inclusion criteria
  • > 18 years

  • First ischaemic or haemorrhagic stroke


Exclusion criteria
  • Unstable medical conditions

  • Unable to understand study aims and procedures

  • Severe aphasia

  • Other progressive neurological disease

  • Previous or concomitant psychiatric illness

  • Not willing to participate

Interventions Experimental: escitalopram and rehabilitation. Escitalopram given 5 mg once a day for the first week, 10 mg once a day from the second to fourth week, and 20 mg daily until the 6th month
Comparator: placebo and rehabilitation
Outcomes Primary outcome collected at 2 and 6 months
  • FIM


Secondary outcomes collected at 2 and 6 months:
  • MMSE

  • Trunk Control Test

  • Canadian Stroke Scale

  • Motricity Index

  • Token test

  • The Bells Test

  • Stroop Test

  • Wisconsin Card Sorting test

  • Verbal Fluency

  • Raven's Matrices Test

  • Trail Making A‐B Test

  • Center for Epidemiological Studies Depression Scale

Notes clinicaltrials.gov/ct2/show/NCT00967408
Contacted author Prof Cisari; response received; data being analysed

BDI: Beck Depression Inventory
BI: Bathel Index
FIM: Functional Independence Measure
HAM‐D17: Hamilton Depression Scale
ICD‐10: International Statistical Classification of Diseases, 10th revision
IQR: interquartile range
MMSE: Mini‐Mental State Examination
NIHSS: National Institutes of Health Stroke Scale