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Fluoxetine for Visual Recovery After Ischemic Stroke (FLUORESCE)

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ClinicalTrials.gov Identifier: NCT02737930
Recruitment Status : Terminated (Slow recruitment and lack of funding to expand to other sites.)
First Posted : April 14, 2016
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Bogachan Sahin, University of Rochester

Tracking Information
First Submitted Date  ICMJE April 1, 2016
First Posted Date  ICMJE April 14, 2016
Last Update Posted Date August 25, 2020
Study Start Date  ICMJE May 2016
Actual Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2016)
Improvement in size of visual field deficit (degrees) [ Time Frame: 6 months ]
Improvement at each point in the Humphrey visual field will be defined as a decrease of more than 6 decibels (dB) in the threshold required to elicit a response at that location. This is based on the unidirectional test-retest variability of less than 3 dB reported in the Humphrey Field Analyzer manual. The primary 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2016)
  • Improvement in size of visual field deficit (square degrees) [ Time Frame: 6 months ]
    Improvement at each point in the Humphrey visual field will be defined as a decrease of more than 6 dB in the threshold required to elicit a response at that location, as described in Outcome 1. The area of improvement in the visual field deficit will be measured in square degrees across test locations showing at least a 6-dB decrease in threshold values.
  • Improvement in parametric mean deviation [ Time Frame: 6 months ]
    Parametric 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.
  • 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.
  • Visual Function Questionnaire-25 score [ Time Frame: 6 months ]
  • Patient Health Questionnaire-9 score [ Time Frame: 6 months ]
  • 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.
  • Post-stroke changes in retinal nerve fiber layer thickness [ Time Frame: 6 months ]
    This will be measured by spectral domain optical coherence tomography.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluoxetine for Visual Recovery After Ischemic Stroke
Official Title  ICMJE Fluoxetine for Visual Recovery After Ischemic Stroke
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Stroke
  • Visual Field Loss
Intervention  ICMJE
  • Drug: Fluoxetine
    Other Names:
    • Prozac
    • Sarafem
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Fluoxetine
    20 mg fluoxetine capsule by mouth once daily for 90 days
    Intervention: Drug: Fluoxetine
  • Placebo Comparator: Placebo
    Matching placebo
    Intervention: Drug: Placebo
Publications * Zhang X, Kedar S, Lynn MJ, Newman NJ, Biousse V. Natural history of homonymous hemianopia. Neurology. 2006 Mar 28;66(6):901-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 20, 2020)
17
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2016)
40
Actual Study Completion Date  ICMJE August 2020
Actual Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02737930
Other Study ID Numbers  ICMJE RSRB00058133
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bogachan Sahin, University of Rochester
Study Sponsor  ICMJE Bogachan Sahin
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Rochester
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP