Fluoxetine for Visual Recovery After Ischemic Stroke (FLUORESCE)

Bogachan Sahin

Status and phase: Terminated; Phase 2

Conditions: Visual Field Loss; Acute Stroke

Treatments: Drug: Placebo; Drug: Fluoxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT02737930

RSRB00058133

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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17 participants in 2 patient groups, including a placebo group

Fluoxetine

Experimental group

Description:

20 mg fluoxetine capsule by mouth once daily for 90 days

Treatment:

Drug: Fluoxetine

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo