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Fluoxetine for Visual Recovery After Ischemic Stroke (FLUORESCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02737930
Recruitment Status : Terminated (Slow recruitment and lack of funding to expand to other sites.)
First Posted : April 14, 2016
Results First Posted : October 13, 2021
Last Update Posted : October 13, 2021
Sponsor:
Information provided by (Responsible Party):
Bogachan Sahin, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Acute Stroke Visual Field Loss Drug: Fluoxetine Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fluoxetine for Visual Recovery After Ischemic Stroke
Study Start Date : May 2016
Actual Primary Completion Date : August 2020
Actual Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke
Drug Information available for: Fluoxetine

Arm Intervention/treatment
Experimental: Fluoxetine
20 mg fluoxetine capsule by mouth once daily for 90 days
Drug: Fluoxetine
Other Names:
  • Prozac
  • Sarafem

Placebo Comparator: Placebo
Matching placebo
Drug: Placebo



Primary Outcome Measures :
  1. Percent Change in the Bionocularly Averaged Perimetric Mean Deviation [ Time Frame: 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.


Secondary Outcome Measures :
  1. Mean Percent Change in Field Points Tested [ Time Frame: 6 months ]
    Visual field recovery is defined as an improvement of more than 6 decibels (dB) in the threshold required to elicit a response at each point in the Humphrey visual field. This is based on the unidirectional test-retest variability of less than 3 dB reported in the Humphrey Field Analyzer manual. The endpoint will be an improvement in threshold values at test locations spanning more than 10 degrees horizontally or 15 degrees vertically in the Humphrey visual field in both eyes at 6 months, based on the definition of visual improvement used by Zhang et al. in their natural history study of stroke patients with hemianopia.

  2. Number of Participants With >95% Recovery [ Time Frame: 6 months ]
    Recovery is an improvement in the blind visual field. Participants were counted if the percentage of visual field that was blind was reduced by 95%.

  3. Functional Field Score [ Time Frame: 6 months ]
    This is a measure of functional peripheral vision in patients with otherwise normal visual acuity. It is calculated from perimetric data. Scores of 75-110 indicate near-normal to normal vision, 55-70 moderate low vision, 35-50 severe low vision, 15-30 profound low vision, and less than 15 near to total blindness. Hemianopia is considered severe low vision.

  4. Percent Change in Mean Visual Function Questionnaire-25 Score [ Time Frame: baseline to 6 months ]
    The VFQ-25 consists of a base set of 25 vision targeted questions representing 11 vision-related constructs: global vision rating, difficulty with near vision activities, difficulty with distance vision activities, limitations in social functioning due to vision, role limitations due to vision, dependency on others due to vision, mental health symptoms due to vision, driving difficulties, limitations with peripheral and color vision, and ocular pain. The scores range from 0-100 with higher scores indicating better functioning.

  5. Median Change in Patient Health Questionnaire-9 Score [ Time Frame: baseline to 6 months ]
    This is a self-report inventory used as a screening and diagnostic tool for depression (Appendix F). The 9 items are based on the 9 diagnostic criteria for depression included in the Diagnostic and Statistical Manual of Mental Disorders IV. The scales ranges from 0-27 with higher scores indicating worse outcome.

  6. Median Modified Rankin Scale Score [ Time Frame: 90 days ]
    This is a functional outcome measure widely used in stroke clinical trials, with a score of 0 indicating no disability, 6 indicating death, and scores of 2 or less generally accepted to indicate a favorable functional outcome.

  7. Post-stroke Changes in Cortical Visual Representation as Measured by Functional Magnetic Resonance Imaging [ Time Frame: 6 months ]
    Functional magnetic resonance imaging is a high-resolution imaging technique that can be used to measure cortical visual representation and functional activity during visual tasks using blood oxygen level-dependent responses. In stroke patients, this technique can be used to characterize the degree and nature of peri-lesional remapping of regions of the blind visual field during post-stroke visual recovery. Standard retinotopic mapping procedures will be used to determine the number of voxels in the early visual cortex that represent information about stimuli presented in the blind field of each patient.

  8. Mean Percent Change in Post-stroke Retinal Nerve Fiber Layer Thickness [ Time Frame: baseline to 6 months ]
    This will be measured by spectral domain optical coherence tomography. Optical coherence tomography is a method of using low-coherence interferometry to determine the echo time delay and magnitude of backscattered light reflected off an object of interest. This method can be used to scan through the layers of a structured tissue sample such as the retina with very high axial resolution (3 to 15 μm), providing images demonstrating 3D structure.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737930


Locations
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United States, New York
Strong Memorial Hospital
Rochester, New York, United States, 14642
Sponsors and Collaborators
Bogachan Sahin
  Study Documents (Full-Text)

Documents provided by Bogachan Sahin, University of Rochester:
Informed Consent Form  [PDF] August 27, 2019

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bogachan Sahin, Assistant Professor of Neurology, University of Rochester
ClinicalTrials.gov Identifier: NCT02737930    
Other Study ID Numbers: RSRB00058133
First Posted: April 14, 2016    Key Record Dates
Results First Posted: October 13, 2021
Last Update Posted: October 13, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bogachan Sahin, University of Rochester:
Acute ischemic stroke
Homonymous hemianopia
Homonymous quadrantanopia
Visual field loss
Post-stroke recovery
Fluoxetine
Selective serotonin reuptake inhibitor
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors