Sahin 2016.

Trial name or title	Fluoxetine for visual recovery after ischemic stroke (FLUORESCE)
Methods	Study type: interventional (clinical trial) Estimated enrolment : 40 participants Allocation: randomised Intervention model: parallel assignment Masking: quadruple (participant, care provider, investigator, outcomes assessor) Primary purpose: treatment
Participants	USA Inclusion criteria 18 to 85 years Inclusion criteria: MRI‐confirmed acute ischaemic stroke resulting in an isolated homonymous visual field loss Exclusion criteria: Known hypersensitivity to fluoxetine or other SSRIs NIHSS score > 5 Premorbid mRS score > 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 hyponatraemia 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 Haemorrhagic transformation of the index stroke, resulting in mass effect Enrolment in another clinical trial at the time of the index stroke Aiming to recruit 40 participants
Interventions	Experimental: 20 mg fluoxetine capsule by mouth once daily for 90 days Comparator: matching placebo
Outcomes	Outcomes collected at 6 months Primary outcome Improvement in size of visual field deficit at 6 months Secondary outcomes Improvement in size of visual field deficit at 6 months Functional field score at 6 months Visual Function Questionnaire‐25 score at 6 months PHQ‐9 score at 6 months mRS score at 90 days Post‐stroke changes in cortical visual representation as measured by functional magnetic resonance imaging at 6 months Post‐stroke changes in retinal nerve fibre layer thickness at 6 months
Starting date	May 2016
Contact information	Bogachan Sahin bogachan_sahin@rocheter.edu
Notes	NCT02737930

BDI: Beck Depression Inventory; BDNF: brain‐derived neurotrophic factor; BI: Barthel Index; CT: computerised tomography; CTIMP: Clinical Trial of an Investigational Medicinal Product;
 DWI: diffusion‐weighted imaging; FAI: Frenchay Activities Index; FLAIR: fluid‐attenuated inversion recovery; FMMS: Fugl Meyr Motor Score; fMRI: functional magnetic resonance imaging; HAM‐D: Hamilton Depression Rating Scale; HRQoL: Health‐Related Quality of Life; JTT: Jebsen Taylor Test; MADRS: Montgomery‐Åsberg Depression Rating Scale; MAOI: mono‐amino‐oxidase inhibitor; MCA: middle cerebral artery; MEP: motor evoked potential; MHI 5: Mental Health Inventory; MHRA: Medicines and Healthcare products Regulatory Agency
 MRA: magnetic resonance angiography; MRI: magnetic resonance imaging; mRS: modified Rankin score; NHP: Nottingham Health Profile; NIHSS: National Institute of Health Stroke Scale
 NPI: Neuropsychiatric Inventory Scale; PHQ‐9: Patient Health Questionnaire; rTMS: repetitive transcranial magnetic stimulation; SF‐36: Short Form‐36; SIS: Stroke Impact Scale; smRSq: simplified modified Rankin Scale questionnaire; SSRI: selective serotonin reuptake inhibitor; TCD: transcranial Doppler; TIA: transient ischaemic attack; TICSm: telephone interview for cognitive status ‐ modified; TMS: transcranial magnetic stimulation