Fluoxetine for Visual Recovery After Ischemic Stroke
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Percent Change in the Bionocularly Averaged Perimetric Mean Deviation
研究概览
简要总结
The purpose of this study is to determine whether fluoxetine, a selective serotonin reuptake inhibitor commonly used for depression, enhances visual recovery after an acute ischemic stroke.
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
- •MRI-confirmed acute ischemic stroke resulting in an isolated homonymous visual field loss.
排除标准
- •Known hypersensitivity to fluoxetine or other selective serotonin reuptake inhibitors
- •National Institutes of Health Stroke Scale score greater than 5
- •Premorbid modified Rankin Scale score greater than 2
- •Premorbid monocular or binocular visual field deficits
- •Premorbid retinopathy or optic neuropathy
- •Premorbid depression
- •History of cognitive impairment, dementia, or neurodegenerative disorder
- •History of seizure disorder
- •History of mania or hypomania
- •History of hyponatremia
- •History of angle-closure glaucoma or elevated intraocular pressure
- •Current alcohol abuse or impaired liver function
- •Current use of an antidepressant medication
- •Current use of a medication likely to have an adverse interaction with fluoxetine
- •Current use of a medication likely to impair post-stroke recovery
- •Contraindication to MRI
- •Pregnancy or lactation
- •Hemorrhagic transformation of the index stroke, resulting in mass effect
- •Enrollment in another clinical trial at the time of the index stroke
研究组 & 干预措施
Fluoxetine
20 mg fluoxetine capsule by mouth once daily for 90 days
干预措施: Fluoxetine (Drug)
Placebo
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change in the Bionocularly Averaged Perimetric Mean Deviation
时间窗: baseline to 6 months
24-2 Humphrey perimetry was completed for each eye (Zeiss HFAIIi, Swedish Interactive Threshold Algorithm (SITA) Standard, size III white target, fixation enforced, corrected for near vision). The cutoff of a sensitivity of 10 dB to define sighted versus blind test locations was chosen. Perimetric mean deviation is a summary statistic calculated by measuring the deviation from the expected threshold value for stimulation at each point in the visual field and taking an average, with possible values ranging from +2 to -32 dB.
次要结局
- Median Change in Patient Health Questionnaire-9 Score(baseline to 6 months)
- Mean Percent Change in Field Points Tested(6 months)
- Number of Participants With >95% Recovery(6 months)
- Functional Field Score(6 months)
- Mean Percent Change in Post-stroke Retinal Nerve Fiber Layer Thickness(baseline to 6 months)
- Percent Change in Mean Visual Function Questionnaire-25 Score(baseline to 6 months)
- Median Modified Rankin Scale Score(90 days)
- Post-stroke Changes in Cortical Visual Representation as Measured by Functional Magnetic Resonance Imaging(6 months)
研究者
Bogachan Sahin
Assistant Professor of Neurology
University of Rochester