Marquez Romero 2013.

Methods	Multicentre Study type: interventional (clinical trial) Primary purpose: supportive care
Participants	32 participants Country: Mexico Setting: inpatient At randomisation number allocated: N = 32: fluoxetine (n = 15); placebo (n = 17) % men: 50% Age: mean age 55.1 ± 12.2 Subtype of stroke: not available Severity of stroke: NIHSS, Median (IQR): fluoxetine (12 (5)); placebo (14 (5)) Time since stroke onset: within 10 days Inclusion criteria: Age > 18 years Patients who had an acute intracerebral haemorrhage within the past 10 days causing hemiparesis or hemiplegia FMMS scores of ≤ 55 Written informed consent Exclusion criteria: NIHSS score > 20 Premorbid disability, evidenced by residual motor deficit from a previous stroke Comprehension deficit or severe aphasia Previous diagnosis of depression or one of the following:Hospital Anxiety and Depression Scale score ≥ 11 points; taking antidepressant drugs 2 weeks before inclusion Use of neuroleptic drugs or benzodiazepines 2 weeks before inclusion Other life‐threatening illnesses Withdrawal criteria: Detection of eligibility violations Poor compliance (< 90%) or noncompliance Use of any medication or treatment during the trial that could affect the study results Occurrence of a serious adverse event: participant has an acute reaction (allergy, shock) to the investigational product participant develops depression, evidenced by HAD score ≥ 11 points at visit participant withdraws consent or is unco‐operative
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 Secondary outcomes BI (baseline and 90 days): change from baseline in BI at 90 days mRS (baseline and 90 days): change from baseline in mRS at 90 days NIHSS (baseline and 90 days): change from baseline in NIHSS at 90 days
Funding source	Psicofarma S.A. de C.V.
Notes	NCT01737541 Terminated (study recruitment was suspended due to lack of funding) Dates study conducted: November 2012 to August 2014 Declarations of Interest: none reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "A pharmaceutical laboratory (Psicofarma™ S.A. de C.V.) will be responsible for the manufacture and randomization of the investigational product, which will be achieved using a web‐based randomization program. This program will be set to assign participants equally to each site at a ratio of 1:1."
Allocation concealment (selection bias)	Low risk	Quote: "Each of the sites will be assigned 22 participants. The manufacturer will then deliver the pre‐randomized bottles containing the investigational product to each recruiting center. Study subjects who satisfy the eligibility criteria at each recruiting center will receive the investigational product corresponding to a consecutive number assigned according to their entrance to the study."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Fluoxetine and placebo tablets will be identical in form, color, odor and packaging." "Both the investigator and the subject will be blinded to the assignment of the study drugs. The manufacturer of the tablets will label the investigational drugs by the randomization code number. The labeled experimental products will be provided to the recruiting centers by the manufacturer. An envelope containing all randomization codes will be delivered to the principal investigator and will be kept sealed until the conclusion of the trial."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinding of participants and key study personnel ensured, and unlikely that blinding could have been broken
Incomplete outcome data (attrition bias) All outcomes	Low risk	Aimed to recruit 44 per group (total of 88) 35 in each group + 20% to allow for predicted 20% loss to follow‐up Actual enrolment N = 32. Quote: "Two patients (one in each group) did not take any medication returning the unopened bottles at visit 1 and had to be excluded from analysis." Comment: Report includes data from 30 participants (14 participants in the fluoxetine group and 16 in the placebo group)
Selective reporting (reporting bias)	Low risk	The study protocol is available and all of the study's prespecified (primary and secondary) outcomes that are of interest in the review have been reported
Other bias	Low risk	The study appears to be free of other sources of bias