Dike 2019.

Study characteristics
Methods	Study type: interventional (clinical trial) Allocation: randomised Intervention model: parallel assignment Masking: single (investigator) Primary purpose: treatment
Participants	60 participants Country: Nigeria Setting: inpatient At randomisation number allocated: N = 1500: fluoxetine (n = 750 ); placebo (n = 750 ) % male: fluoxetine (53.3%); placebo (43.3%) Age: mean age: fluoxetine = 59 ± 11; placebo = 62 ± 9 Inclusion criteria 18 to 85 years of age Ischaemic stroke, unilateral, supra‐tentorial confirmed by neuroimaging Presentation within first 14 days of stroke onset NIHSS score ≤ 16 Hemiparesis or hemiplegia FMMS ≤ 55 Informed consent Exclusion criteria Haemorrhagic stroke on CT Glasgow coma score < 8 NIHSS score > 16 Cardiovascular/metabolic/respiratory instability: hypertensive emergency or hypotension/acidosis or alkalosis/RR > 24 cycles per minute Previous central/peripheral nerve injury Current use of a medication likely to have an adverse interaction with fluoxetine Concurrent medications interacting with SSRI Substantial premorbid disability Depression (MADRS score > 19) Current use of antidepressant medication Pregnancy
Interventions	Experimental: 20 mg fluoxetine for 30 days plus standard treatment Comparator: standard treatment
Outcomes	Primary outcome Changes in FMMS at day 14 and day 30 Secondary outcomes NIHSS at day 30 mRS at day 30
Funding source	N o funding
Notes	PACTR201412000967245. Recruitment between January 2015 and May 2016. All authors declare no conflicts of interest
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Block randomization was used in the assignment of study participants. Permuted blocks of six (6) for two groups were drawn up. A random selection of possibilities was done using a list of random numbers generated with STATA 12."
Allocation concealment (selection bias)	Low risk	Quote: "Allocation concealment was done using sequentially numbered envelopes."
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "This was a single‐blind randomized controlled trial that compared motor recovery between 2 groups of stroke patients: those on fluoxetine 20mg daily + standard therapy; and the control group who received standard therapy only." Thus the participants would have known their treatment allocation
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information provided
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	22/60 lost to follow‐up (presumably including the 7 in the intervention group and the 8 in the control group who died). 6 in fluoxetine group stopped treatment but were still included in the analysis. It is unclear what effect this would have had, hence the judgement about unclear risk of bias
Selective reporting (reporting bias)	Low risk	All the prespecified outcomes were reported
Other bias	Unclear risk	Insufficient information to to assess whether an important risk of bias exists