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Influence of Escitalopram on the incidence of depression and dementia following acute middle cerebral artery territory infarction. A randomized, placebo-controlled, double blind study. - Poststroke Depressio

Conditions
Acute territorial infarction in the territory of the middle cerebral artery (MCA).
Registration Number
EUCTR2005-005266-37-DE
Lead Sponsor
Central Institute for Mental Health, Mannheim, Div. of Gerontopsychiatry
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
60
Inclusion Criteria

an acute MCA territory infarction
over the age of = 18 years
Can be included into this study within 7 days after onset of the stroke
an estimated pre-morbid Rankin Scale (RS) score = 2
The subject must be prepared to and considered able to follow the protocol during the whole trial period and to attend the planned visits, even if the treatment has to be withdrawn.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a history of dementia
a history of recurrent major depression
a history of major stroke
alcohol or drug dependency
any systemic disease, which can influence his/her safety and compliance, or the evaluation of the disability
a woman who is pregnant, breast-feeding or have the possibility for pregnancy during the study. To avoid pregnancy, women have to be menopausal, surgical sterile, sexually inactive or practice reliable contraceptives
any other medical reason at the discretion of the treating physician
participation in any other studies, involving other investigational products, within 30 days prior to participating in this trial
concomitant medication with MAO-inhibitors, triptans, tramaldol, other antidepressants, or lithium
creatinine-clearance <20ml/min or serum creatinine >2,4mg/dl
an impaired liver function (abnormal CHE or Bilirubin >2,0mg/dl)
an estimated life expectancy <6 months

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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