Effect of Serotonin and Levodopa Functional Recovery in Patients With Cerebral Infarction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Rankin Scale
研究概览
简要总结
Cortical plasticity plays a pivotal role in functional recovery after a stroke. Neurotransmitter release, facilitates the creation of new synapses and promotes brain plasticity. In a pilot study, will evaluate the potential benefit of drugs that increase the release of neurotransmitters in patients with first stroke.
详细描述
Methods. Evaluate 240 consecutive patients with a first ischemic stroke with NIHSS 5-20 without aphasia and with a previous independent functional status (mRS <3). Patients will be randomized into four arms: 1) control group, 2) treatment with citalopram 20 mg / day, 3) group levodopa (sinemet plus)100 mg / day, 4) group levodopa (sinemet plus) 100 mg / day + citalopram 20 mg / day.
The treatment begins within the first 5 days of stroke and is maintained for 6 months. All patients will be treated according to current guidelines for secondary prevention. We will assess the following variables: demographic, vascular risk factors, etiologic subtypes according to TOAST criteria, neurologic deficit with the NIHSS scale, cognitive assessment with Minimental scale and functional status with scale modified Rankin at discharge, 3, 6 and 12 months, Symbol Digit Modalities Test (SDMT), GDS-15 Geriatric Depression Scale, Logical memory of WMS-IV . The cognitive assessment and motor functional status will be evaluated by a neuropsychologist and neurologist blinded to treatment assignment.
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
- Single (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
- •• Patients with a first stroke with NIHSS 5-20 points
- •Patients without aphasia to avoid interference in the assessment of depression and cognitive impairment
- •Patients with independent functional status prior to stroke (mRS <3)
- •Patients without prior cognitive impairment or depressive syndrome assessed by medical history with the patient and family.
- •The assigned treatment initiated within the first five days of stroke
排除标准
- •• Patients with prior myocardial or cerebral hemorrhage
- •Patients with TIA
- •Patients with aphasia
- •History of cognitive impairment or prior depressive syndrome
- •Patients with no independent functional status mRS greater than or equal to 3
- •Underlying disease hopefully less than one year of life.
- •Patient pre-treatment with levodopa, an antidepressant or neuroleptic.
研究组 & 干预措施
Placebo
In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.
干预措施: placebo (Other)
citalopram 20 mg
In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.
干预措施: citalopram (Drug)
sinemet plus 100 mg
In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.
干预措施: sinemet plus (Drug)
Sinemet Plus + citalopram group
In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.
干预措施: citalopram (Drug)
Sinemet Plus + citalopram group
In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.
干预措施: sinemet plus (Drug)
结局指标
主要结局
Rankin Scale
时间窗: 12 months
次要结局
未报告次要终点