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Fluoxetine for Visual Recovery After Ischemic Stroke

NCT ID: NCT02737930

Last Updated: 2021-10-13

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2020-08-31

Brief Summary

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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

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Conditions

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Acute Stroke Visual Field Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fluoxetine

20 mg fluoxetine capsule by mouth once daily for 90 days

Group Type EXPERIMENTAL

Fluoxetine

Intervention Type DRUG

Placebo

Matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Fluoxetine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Prozac Sarafem

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bogachan Sahin

OTHER

Sponsor Role lead

Responsible Party

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Bogachan Sahin

Assistant Professor of Neurology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Strong Memorial Hospital

Rochester, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16567709 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36166771 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33230035 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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RSRB00058133

Identifier Type: -

Identifier Source: org_study_id