TCTR20181216001.

Study name	Randomized controlled trial of fluoxetine or placebo on quality of life after acute ischemic stroke
Methods	Study type: interventional (clinical trial) Allocation: randomised Intervention model: parallel assignment Masking: double blind (no detail) Primary purpose: efficacy
Participants	Country: Thailand Setting: inpatient Inclusion criteria Age > 18 Acute ischaemic stroke patient Consent Exclusion criteria History of or current psychiatric condition ‐ hemorrhagic complication EQ‐5D‐5L score > 0.9 Language barrier
Interventions	Experimental: fluoxetine 20 mg once daily for 90 days Comparator: matching placebo once daily for 90 days
Outcomes	Primary outcomes at 3 months Quality of life measured by EQ‐5D‐5L Secondary outcomes at 3 months Post stroke depression measured by Thai HADS Disability measured by the Modified Rankin Score
Starting date	1 January 2019
Contact information	Sirikanya Lorwatanapongsa: sirikanyalor@yahoo.com
Notes	TCTR20181216001

BDI: Beck Depression Inventory; 
BDNF: brain‐derived neurotrophic factor; 
BI: Barthel Index; 
CTIMP: Clinical Trial of an Investigational Medicinal Product;
DWI: diffusion‐weighted imaging; 
FLAIR: fluid‐attenuated inversion recovery; 
FMMS: Fugl Meyr Motor Score; 
fMRI: functional magnetic resonance imaging; 
HAM‐A:Hamilton Anxiety Rating Scale;
HAM‐D: Hamilton Depression Rating Scale; 
JTT: Jebsen Taylor Test; 
MADRS: Montgomery‐Åsberg Depression Rating Scale; 
MAOI: mono‐amino‐oxidase inhibitor; 
MCA: middle cerebral artery; 
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;
QoL: quality of life; 
RCT: randomised controlled trial;
rTMS: repetitive transcranial magnetic stimulation; 
SF‐36: Short Form‐36; 
smRSq: simplified modified Rankin Scale questionnaire; 
SSRI: selective serotonin reuptake inhibitor; 
TCD: transcranial Doppler; 
TIA: transient ischaemic attack;