Black‐Schaffer 2012.

Methods	Study type: interventional (clinical trial) Intervention model: parallel assignment Primary purpose: treatment
Participants	0 participants (aimed to recruit 25 participants) Country: USA Setting: inpatient At randomisation number allocated: 0 % male: not available Age: not available Subtype of stroke: not available Severity of stroke: not available Time since stroke onset: not available Inclusion criteria: Ischaemic infarction within 15 days Admission NIHSS item 5 score ≥ 2 Able to give informed consent, with surrogate consent acceptable Exclusion criteria: Pre‐stroke mRS score equal or ≥ 3 Pregnant or lactating Taking an SSRI on admission Taking a medication likely to have adverse interaction with an SSRI Unable to return for follow‐up testing days 90, 180 Concurrent medical condition likely to worsen patient's functional status over next 6 months Unable to competently participate in testing for 45 minutes to 2 hours with rest breaks for MRI substudy: contraindication to MRI
Interventions	Experimental: fluoxetine 20 mg daily for 90 days starting day 5 to10 after stroke Comparator: placebo participants will take 1 placebo pill daily for 90 days
Outcomes	Primary outcome measures: FMMS (baseline to 90 days, baseline to 180 days) Secondary Outcome Measures Western Aphasia Battery (baseline to 90 days) Behavioral Inattention Test (baseline to 90 days, baseline to 180 days) FIM (baseline to discharge) Fatigue Severity Scale (baseline to 90 days, baseline to 180 days) BDI (baseline to 90 days, baseline to 180 days) Western Aphasia Battery (baseline to 180 days) mRS (baseline to 90 days, baseline to 180 days)
Funding source	Not stated
Notes	clinicaltrials.gov/ct2/show/NCT01674868 Withdrawn ‐ unable to find patients meeting inclusion/exclusion criteria Dates study conducted: April 2013 to December 2015 (estimated completion date) Declarations of Interest: none reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Withdrawn: unable to find patients meeting inclusion/exclusion criteria
Allocation concealment (selection bias)	Unclear risk	Withdrawn: unable to find patients meeting inclusion/exclusion criteria
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Withdrawn: unable to find patients meeting inclusion/exclusion criteria
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Withdrawn: unable to find patients meeting inclusion/exclusion criteria
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Withdrawn: unable to find patients meeting inclusion/exclusion criteria
Selective reporting (reporting bias)	Unclear risk	Withdrawn: unable to find patients meeting inclusion/exclusion criteria
Other bias	Unclear risk	Withdrawn: unable to find patients meeting inclusion/exclusion criteria