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
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to follow the protocol during the whole trial period and to attend the planned visits, even if the treatment has to be withdrawn.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
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
Name Time Method
- Secondary Outcome Measures
Name Time Method