Shah 2016.

Methods	Study type: interventional (clinical trial) Primary purpose: supportive care
Participants	89 participants Country: India Setting: inpatient At randomisation number allocated: N = 89: fluoxetine (n = 45); placebo (n = 44) % male: unclear Age: unclear Subtype of stroke: unclear Severity of stroke: unclear Time since stroke onset: within 5 to 10 days Inclusion criteria: Age 18 to 80 years old Patients who had an acute ICH within the past 5 t0 10 days causing hemiparesis or hemiplegia FMMS scores of 55 or less Exclusion criteria: NIHSS score > 20 Diagnosis of depression MADRS score > 19 points Premorbid disability, evidenced by residual motor deficit from a previous stroke Use of neuroleptic drugs or benzodiazepines 4 weeks before inclusion Other life‐threatening illnesses that would prevent follow‐up Pregnancy Withdrawal criteria: not stated
Interventions	Experimental: fluoxetine 20 mg orally once daily for 90 days Comparator: matching placebo orally once daily for 90 days
Outcomes	Primary outcome FMMS score (baseline and 90 days): change from baseline in FMMS score at 90 days
Funding source	Not stated
Notes	Baseline demographic and clinical characteristics for each group not presented, rather the baseline demographic and clinical characteristics for those completing the trial (i.e. a subset of all those randomised at baseline) are presented Dates study conducted: January 2014 to January 2015 Declarations of Interest: none reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information about the sequence generation process to permit judgement of yes or no
Allocation concealment (selection bias)	Unclear risk	Insufficient information about the method of allocation concealment to permit judgement of yes or no
Blinding of participants and personnel (performance bias) All outcomes	High risk	"Patients, attendants, study staff and investigators were masked to treatment allocation." However, "matching was done on a 1:1 basis for age, sex, severity of stroke " which suggests that some key study personnel were not blinded and this non‐blinding is likely to introduce bias
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgement of yes or no
Incomplete outcome data (attrition bias) All outcomes	High risk	3/45 (7%) participants in the fluoxetine and 2/44 (5%) in the placebo group were lost to follow‐up. Reasons for attrition/exclusion not reported. 6% lost to follow‐up
Selective reporting (reporting bias)	Unclear risk	No study protocol available. Insufficient information to permit judgement of yes or no
Other bias	High risk	The use of matching suggests a matched case control design rather than an RCT design. We cannot tell whether there was any baseline imbalance in important demographic or clinical characteristics