Clinical trial NCT02737930: Fluoxetine for Visual Recovery After Ischemic Stroke
Official title: Fluoxetine for Visual Recovery After Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Stroke
Visual Field Loss
Keywords: Acute ischemic stroke
Homonymous hemianopia
Homonymous quadrantanopia
Visual field loss
Post-stroke recovery
Fluoxetine
Selective serotonin reuptake inhibitor
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* MRI-confirmed acute ischemic stroke resulting in an isolated homonymous visual field loss.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percent Change in the Bionocularly Averaged Perimetric Mean Deviation
timeFrame: baseline to 6 months
Secondary outcomes:
measure: Mean Percent Change in Field Points Tested
timeFrame: 6 months
measure: Number of Participants With >95% Recovery
timeFrame: 6 months
measure: Functional Field Score
timeFrame: 6 months
measure: Percent Change in Mean Visual Function Questionnaire-25 Score
timeFrame: baseline to 6 months
measure: Median Change in Patient Health Questionnaire-9 Score
timeFrame: baseline to 6 months
measure: Median Modified Rankin Scale Score
timeFrame: 90 days
measure: Post-stroke Changes in Cortical Visual Representation as Measured by Functional Magnetic Resonance Imaging
timeFrame: 6 months
measure: Mean Percent Change in Post-stroke Retinal Nerve Fiber Layer Thickness
timeFrame: baseline to 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Strong Memorial Hospital
state: New York
Study officials:
References:
citation: Zhang X, Kedar S, Lynn MJ, Newman NJ, Biousse V. Natural history of homonymous hemianopia. Neurology. 2006 Mar 28;66(6):901-5. doi: 10.1212/01.wnl.0000203338.54323.22.
citation: Schneider CL, Prentiss EK, Busza A, Williams ZR, Mahon BZ, Sahin B. FLUORESCE: A Pilot Randomized Clinical Trial of Fluoxetine for Vision Recovery After Acute Ischemic Stroke. J Neuroophthalmol. 2023 Jun 1;43(2):237-242. doi: 10.1097/WNO.0000000000001654. Epub 2022 Jul 8.
citation: Saionz EL, Feldon SE, Huxlin KR. Rehabilitation of cortically induced visual field loss. Curr Opin Neurol. 2021 Feb 1;34(1):67-74. doi: 10.1097/WCO.0000000000000884.