Acute territorial infarction in the territory of the middle cerebral artery (MCA).
Conditions
Interventions
Trade Name: Cipralex 10 mg Ftbl Z 55880.01.00
Product Name: Cipralex
Pharmaceutical Form: Tablet
INN or Proposed INN: Escitalopram
CAS Number: 219861-08-2
Concentration unit: mg milligram(s)
Concentra
Sponsors
Central Institute for Mental Health, Mannheim, Div. of Gerontopsychiatry
Eligibility
Sex/Gender
All
Inclusion criteria
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to follow the protocol during the whole trial period and to attend the planned visits, even if the treatment has to be withdrawn.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
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 2,4mg/dl an impaired liver function (abnormal CHE or Bilirubin >2,0mg/dl) an estimated life expectancy <6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective in this study is to estimate in subjects after acute MCA territory infarction: The effect of escitalopram 10 mg/d compared to the effect of placebo · On the incidence of poststroke depression as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) after 180 days following acute middle cerebral artery territory infarction · On the Incidence of dementia as measured by the Clinical Dementia Rating Scale (CDR, >0,5) after 180 days following acute middle cerebral artery territory infarction ;Secondary Objective: The secondary objective in this study is to estimate in subjects after acute MCA territory infarction: The effect of escitalopram 10 mg/d compared to the effect of placebo: · On the severity of dementia as measured with the CERAD test battery after 180 days following acute middle cerebral artery territory infarction · On the degree of burden for the patient’s relatives as estimated with the Zarit Burden Interview after 180 days following acute middle cerebral artery territory infarction · On the incidence of Depression as measured with the D-VAS (Depression Visual Analog Scale) · On the severity of poststroke depression as measured with the MADRS after 180 days following acute middle cerebral artery territory infarction · On the quality of life as measured with the SF-36 · On the extent of functional impairment as measured by the BAYER Activities of Daily Living scale (ADL) · On the behavioural symptomatology as measured by the Neuropsychiatric Inventory Scale (NPI) ;Primary end point(s): The incidence of poststroke depression as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) after 180 days following acute middle cerebral artery territory infarction The Incidence of dementia as measured by the Clinical Dementia Rating Scale (CDR, >0,5) after 180 days following acute middle cerebral artery territory infarction | — |
Countries
Germany
Outcome results
None listed