Effects on Clinical and Functional Outcome of Escitalopram in Adult Stroke
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Functional Independence Measure
研究概览
简要总结
Rehabilitative treatment in stroke survivors has shown to be effective in improving functional outcome and reducing dependency. Plasticity of the central nervous system, along with coping strategies and adaptations, seems to play a key role in functional recovery. Some data support the hypothesis that drug which improve dopaminergic, serotoninergic and noradrenergic transmission in the central nervous system could improve recovery in stroke patients. In this population, antidepressants as selective serotonin reuptake inhibitors (SSRI) are associated to better outcomes, as evidenced by small clinical trials. However, since depression is a common consequence of stroke, observed improvements could be biased by the action of these drugs on depressive symptoms, thus improving participation in rehabilitative treatment.
The hypothesis of this study is that SSRI could improve functional outcome in stroke survivors not only because of their action on depressive symptoms, but mainly because of a direct effect on neural repair and neuronal growth.
The aim of the study is to evaluate the effect of a SSRI, escitalopram, on functional outcome of stroke patients.
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
- •both gender
- •age > 18 years
- •first ischaemic and haemorrhagic stroke
排除标准
- •unstable medical conditions
- •unable to understand study aims and procedures
- •severe aphasia
- •other progressive neurological disease
- •previous or concomitant psychiatric illness
- •patients not willing to participate to the study
研究组 & 干预措施
Rehabilitation + Escitalopram
Rehabilitative treatment + Oral Escitalopram 5 mg/day for the first week, 10 mg/day from second to fourth week and 20 mg/day until 6th month.
干预措施: Escitalopram (Drug)
Rehabilitation + Escitalopram
Rehabilitative treatment + Oral Escitalopram 5 mg/day for the first week, 10 mg/day from second to fourth week and 20 mg/day until 6th month.
干预措施: Rehabilitative treatment (Other)
Rehabilitation + Placebo
Rehabilitative treatment + Non active Placebo tablets for 6 months
干预措施: Placebo (Drug)
Rehabilitation + Placebo
Rehabilitative treatment + Non active Placebo tablets for 6 months
干预措施: Rehabilitative treatment (Other)
结局指标
主要结局
Functional Independence Measure
时间窗: Enrollment, 2 and 6 months
次要结局
- Mini-mental state examination (MMSE)(Enrollment, 2 and 6 months)
- Trunk Control Test(Enrollment, 2 and 6 months)
- The Bells Test(Enrollment, 2 and 6 months)
- Stroop Test(Enrollment, 2 and 6 months)
- Canadian Stroke Scale(Enrollment, 2 and 6 months)
- Motricity Index(Enrollment, 2 and 6 months)
- Token test(Enrollment, 2 and 6 months)
- Wisconsin Card Sorting test(Enrollment, 2 and 6 months)
- Verbal Fluency(Enrollment, 2 and 6 months)
- Raven's Matrices Test(Enrollment, 2 and 6 months)
- Trail Making A-B Test(Enrollment, 2 and 6 months)
- Center for Epidemiological Studies Depression Scale(Enrollment, 2 and 6 months)