NCT02737930

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 13, 2021

Completed
Last Updated

October 13, 2021

Status Verified

September 1, 2021

Enrollment Period

4.3 years

First QC Date

April 1, 2016

Results QC Date

August 4, 2021

Last Update Submit

September 16, 2021

Conditions

Acute StrokeVisual Field Loss

Keywords

Acute ischemic strokeHomonymous hemianopiaHomonymous quadrantanopiaVisual field lossPost-stroke recoveryFluoxetineSelective serotonin reuptake inhibitor

Outcome Measures

Primary Outcomes (1)

  • Percent Change in the Bionocularly Averaged Perimetric Mean Deviation

    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.

    baseline to 6 months

Secondary Outcomes (8)

  • Mean Percent Change in Field Points Tested

    6 months

  • Number of Participants With >95% Recovery

    6 months

  • Functional Field Score

    6 months

  • Percent Change in Mean Visual Function Questionnaire-25 Score

    baseline to 6 months

  • Median Change in Patient Health Questionnaire-9 Score

    baseline to 6 months

  • +3 more secondary outcomes

Study Arms (2)

Fluoxetine

EXPERIMENTAL

20 mg fluoxetine capsule by mouth once daily for 90 days

Drug: Fluoxetine

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

FluoxetineDRUG
Also known as: Prozac, Sarafem
Fluoxetine
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MRI-confirmed acute ischemic stroke resulting in an isolated homonymous visual field loss.

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Strong Memorial Hospital

Rochester, New York, 14642, United States

Location

Related Publications (3)

  • 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.

    PMID: 16567709BACKGROUND

  • 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.

    PMID: 36166771DERIVED

  • 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.

    PMID: 33230035DERIVED

MeSH Terms

Conditions

StrokeIschemic StrokeHemianopsia

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesVision DisordersSensation DisordersNeurologic ManifestationsBlindnessEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Results Point of Contact

Title
Bogachan Sahin
Organization
University of Rochester
bogachan_sahin@urmc.rochester.edu
(585) 275-2530

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Neurology

Study Record Dates

First Submitted

April 1, 2016

First Posted

April 14, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

October 13, 2021

Results First Posted

October 13, 2021

Record last verified: 2021-09

Locations

US(1)