Effects of 3 Months Daily Treatment With Selective Serotonin Reuptake Inhibitor (SSRI, Fluoxetine) on Motor Rehabilitation After Ischemic Stroke. FLAME Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Progression in the Fugl-Meyer Motor Scale
研究概览
简要总结
Recovery from stroke is a major process and, except for acute intravenous thrombolysis, no treatment able to enhance recovery has yet been validated. Some drugs may have a positive effect when combined with physical rehabilitation. Previous studies have shown a potential effect of catecholaminergic drugs on cerebral plasticity of stroke patients. In 2001, our group has demonstrated in a small group of stroke patients (n=8) that a single dose of fluoxetine (Selective Serotonin Reuptake Inhibitor - SSRI) improved motor performance and modulated cerebral plasticity. We conducted a phase IIb prospective, double-blind, randomized, placebo controlled study to assess the effect of a daily treatment with fluoxetin (20 mg) on motor performance in patients with mild to severe motor deficit after ischemic stroke.
详细描述
We project to include in the study a maximum of 168 patients with a recent (5 to 10 days) ischemic stroke and unilateral motor deficit in order to obtain 100 completed patients. Nine stroke centers in France are involved.
Each patient will receive daily, during three months, 20 mg of fluoxetin or placebo.
Patients will be evaluated at inclusion, day 30, M3 (3 months), M12.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged from 18 to 85
- •No motor relapse from a previous stroke
- •Inclusion from day 5 to day 10 after stroke
- •Ischemic stroke with unilateral motor deficit
- •Motor NIHSS ≥ 5 on the affected side of the body
- •NIHSS < 20
- •Fugl Meyer Motor Scale <55
- •Modified Rankin Scale between 1 and 5
- •Informed consent obtained from the subject or a member of his family
排除标准
- •Pregnant or breast-feeding woman
- •Woman able to procreate without valid contraception
- •Subject protected by law
- •Concomitant disease with unfavourable prognosis within 1 year
- •Drug addiction
- •Allergy to fluoxetine
- •Hepatic failure (TGO and TGP >2N)
- •Permanent Renal failure (Creatinin >180micromol/l)
- •Patients treated by tricyclic antidepressant, selective serotonin reuptake inhibitor, monoamine oxidase inhibitor (IMAO), and neuroleptics in the past month
- •Depression requiring pharmacological treatment
- •Previous stroke with motor relapse
- •Fugl Meyer Motor Scale > 55
- •Modified Rankin Scale = 0 or 6
- •Patients needing carotid surgery within 3 months
- •Aphasia preventing correct evaluation of motor and depression scales.
研究组 & 干预措施
1
fluoxetine
干预措施: fluoxetine (Drug)
2
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Progression in the Fugl-Meyer Motor Scale
时间窗: M3 (3 months)
次要结局
- Fugl-Meyer Stroke Scale(M12 (12 months))
- NIH stroke scale(M3 and M12)
- Modified Rankin scale(M3 and M12)
- Mortality(M3 and M12)
- MADRS depression scale(M3 and M12)