Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02737930
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : August 21, 2019
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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

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. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  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. Visual Function Questionnaire-25 score [ Time Frame: 6 months ]
  5. Patient Health Questionnaire-9 score [ Time Frame: 6 months ]
  6. 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. Post-stroke changes in retinal nerve fiber layer thickness [ Time Frame: 6 months ]
    This will be measured by spectral domain optical coherence tomography.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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


Contacts
Layout table for location contacts
Contact: Bogachan Sahin, MD, PhD (585) 275-2530 bogachan_sahin@urmc.rochester.edu
Contact: Ann M Leonhardt, NP (585) 275-2530 ann_leonhardt@urmc.rochester.edu

Locations
Layout table for location information
United States, New York
Strong Memorial Hospital Recruiting
Rochester, New York, United States, 14642
Contact: Bogachan Sahin, MD, PhD    585-275-2530    bogachan_sahin@urmc.rochester.edu   
Contact: Ann M Leonhardt, NP    585-275-2530    ann_leonhardt@urmc.rochester.edu   
Sponsors and Collaborators
Bogachan Sahin

Publications:
Layout table for additonal information
Responsible Party: Bogachan Sahin, Assistant Professor of Neurology, University of Rochester
ClinicalTrials.gov Identifier: NCT02737930     History of Changes
Other Study ID Numbers: RSRB00058133
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

Layout table for additional information
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:
Layout table for MeSH terms
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