Efficacy of Escitalopram Treatment in Acute Stroke and the Role of SERT Genotype in Stroke
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- New vascular events
研究概览
简要总结
Growing international scientific evidence has indicated a positive effect of SSRI treatment (serotonin reuptake inhibitors) after stroke, beyond its antidepressant effect. We wish to conduct a prospective randomised double blind placebo-controlled multicenter study of the combined neuroprotective and antithrombotic effects of SSRI treatment after stroke. Deletion of the SERT (serotonin transporter) gene may influence this treatment effect and may in itself be a risk factor for stroke, an aspect we also wish to explore.
Hypotheses:
- SSRI treatment commenced in the acute phase of stroke (day 2-5) protects against new thromboembolic events and leads to better rehabilitation.
- A specific SERT genotype is associated with an increased risk of first ever stroke.
- A specific SERT genotype is associated with a higher risk of post stroke depression.
600 stroke patients will be randomised to either escitalopram or placebo treatment in a 1:1 ratio and genotyped according to SERT polymorphisms. The treatment and follow up period is 6 months. During these 6 months there will be 2 clinical follow up visits, one telephone control and one visit to evaluate compliance regarding medication. Patients who had an MRI as a part of the routine investigations done upon admission (approximately 300 patients) will have a control MRI after 6 months.
Additionally 400 patients, not eligible for participation i the randomised controlled trial, will be genotyped and answer questionnaires after 1 and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First ever ischemic stroke
- •Age 18 years or above
- •Exclusion Criteria
- •Hemorrhagic stroke
- •Dementia or other neurodegenerative disease
- •Antidepressant treatment within 6 months of admission
- •Acute need for antidepressant treatment
- •Drug abuse or other conditions that may indicate noncompliant behavior
- •Liver failure (increased liver enzyme levels up to or more than 2 times upper limit)
- •Renal failure (GFR under 30)
- •Hyponatremia (S-potassium below 130 mmol/l)
- •Actively bleeding ulcer
- •Fatal stroke or other severe co morbidity that markedly decreases expected life span
- •Prolonged QT interval (QTc above 500 ms)
- •Ongoing treatment with drugs known to prolong the QT interval
排除标准
- 未提供
研究组 & 干预措施
Escitalopram
干预措施: Escitalopram (Drug)
Non active drug
干预措施: Placebo (Drug)
结局指标
主要结局
New vascular events
时间窗: 6 months
次要结局
- Bleeding complications(6 months)
- Combined vascular death(6 months)
- Cognitive abilities(6 months)
- Death of any cause(6 months)
- Myocardial Infarction(6 months)
- Re-stroke(6 months)
- Motor function(6 months)
- White Matter lesions(6 months)