Pilot RCT of Fluoxetine vs Placebo to Treat Motor, Language and Unilateral Neglect After Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Motor Scale (FMMS)
研究概览
简要总结
This pilot study will recruit 25 subjects to assess the feasibility of replicating the FLAME study (Chollet, et al. Lancet 2011), a randomized controlled trial (RCT) that assessed the effect of fluoxetine vs placebo on motor recovery after ischemic stroke, in an American sample of post-acute stroke patients. This trial will in addition examine the effect of treatment with fluoxetine versus placebo on concurrent deficits in language and hemispatial attention, as well as post-stroke fatigue and will evaluate the durability of observed effects. The results of this pilot trial will be used to develop power estimates for a larger trial and to evaluate recruitment and intervention completion rates for subjects in an American post-acute environment. There are two additional substudies: the first will use MRI to assess structural changes at the beginning and end of the intervention; the second will examine the relationship of serum biomarkers of inflammation to the intervention.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic infarction within 15 days
- •Admission NIHSS item 5 score equal to or >2 -Able to give informed consent, with surrogate consent acceptable-
排除标准
- •Pre-stroke modified Rankin Scale score equal or .3
- •Pregnant or lactating
- •Taking an SSRI on admission to SRH
- •Taking a medication likely to have adverse interaction with an SSRI
- •Unable to return for follow-up testing days 90,180
- •Concurrent medial condition likely to worsen patient's functional status over next 6 months
- •Unable to competently participate in testing for 45min-2hrs with rest breaks
- •for MRI substudy: contraindication to MRI
研究组 & 干预措施
Fluoxetine
Subjects will take 20 mg fluoxetine daily for 90 days after stroke
干预措施: fluoxetine (Drug)
placebo
Subjects will take one pill daily for 90 days after stroke.
干预措施: placebo (Drug)
结局指标
主要结局
Fugl-Meyer Motor Scale (FMMS)
时间窗: baseline to 180 days
change in FMMS
次要结局
- Western Aphasia Battery(baseline to 180 days)
- Behavioral Inattention Test (BIT)(baseline to 180 days)
- modified Rankin Scale(baseline to 180 days)
- Functional Independence Measure(baseline to discharge)
- Beck Depression Inventory(baseline to 180 days)
- Fatigue Severity Scale(baseline to 180 days)
研究者
Randie Black-Schaffer MD
Medical Director, Stroke Program
Spaulding Rehabilitation Hospital