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

Anonymous 2005.

Trial name or title Influence of escitalopram on the incidence of depression and dementia following acute middle cerebral artery territory infarction. A randomised, placebo‐controlled, double‐blind study
Methods Study type: interventional (clinical trial)
Estimated enrolment: 60 participants
Allocation: randomised
Intervention model: parallel assignment
Masking: double (detail unclear)
Primary purpose: prevention
Participants Country: Germany
Setting: inpatient
Inclusion criteria
  • Acute MCA territory infarction

  • Aiming to recruit 60 over 3 years

  • Within 7 days of stroke onset

  • Prepared to and considered able to follow the whole trial period


Exclusion criteria:
  • Dementia

  • Recurrent major depression

  • Major stroke

  • Alcohol and drug dependency

  • Pregnancy, breastfeeding

  • Participating in other trials of medicinal products

  • Impaired liver/kidney disease

  • Life expectancy less than 6 months


Aiming to recruit 60 participants
Interventions Experimental: escitalopram
Comparator: placebo
Outcomes Depression (MADRS) after 180 days
Incidence of dementia after 180 days (Clinical Dementia Rating scale)
Severity of dementia
Zarit Burden Interview
Incidence of depression (Depression Visual Analogue Scale)
Severity of post‐stroke depression
Quality of life (SF‐36)
Bayer Activities of Daily Living score
NPI
Starting date MHRA approval 7 April 2006; start date not known
Contact information Not available. National Competent authority is Germany‐BFarm
Sponsor Name: Central Institute for Mental Health, Mannheim, Division of Gerontopsychiatry
Notes Details available on EudraCT website
www.clinicaltrialsregister.eu/ctr‐search/trial/2005‐005266‐37/DE