Fluoxetine for Visual Recovery After Ischemic Stroke (FLUORESCE)
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| ClinicalTrials.gov Identifier: NCT02737930 |
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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
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Sponsor:
Bogachan Sahin
Information provided by (Responsible Party):
Bogachan Sahin, University of Rochester
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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 |
| 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 |
|---|---|
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Experimental: Fluoxetine
20 mg fluoxetine capsule by mouth once daily for 90 days
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Drug: Fluoxetine
Other Names:
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Placebo Comparator: Placebo
Matching placebo
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Drug: Placebo |
Primary Outcome Measures :
- 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 :
- 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.
- 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%.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
| 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:
Documents provided by Bogachan Sahin, University of Rochester:
Study Protocol and Statistical Analysis Plan [PDF] March 15, 2016
Informed Consent Form [PDF] August 27, 2019
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| 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:
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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 |