E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute territorial infarction in the territory of the middle cerebral artery (MCA). |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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
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E.2.2 | Secondary objectives of the trial |
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)
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is defined as the last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |