Birchenall 2019.

Methods	Study type: interventional (clinical trial) Intervention model: parallel assignment Primary Purpose: treatment
Participants	6 participants Country: France Setting: inpatient At randomisation number allocated: 6 although unclear as to which group % male: not available Age: not available Subtype of stroke: not available Severity of stroke: not available Time since stroke onset: not available Inclusion criteria: Age 18 to 80 years. Social security affiliation Day 3 to day 15 after stroke or brain haemorrhage Hemiparesia with upper limb motor deficit (Fugl‐Meyer score ‐ hand ≤ 10) Informed consent Exclusion criteria: NIHSS > 20 Depression (criteria DSM5‐R) with MADRS score > 19 History of recurrent bipolar or depressive disorders History of behavior or suicidal idea Family history of extension of the interval QT or congenital long interval QT History of clinical stroke Aphasia preventing correct evaluation of motor and depression scales. Patients treated by antidepressant drugs, IMAO, and neuroleptics in the past month Benzodiazepines within 48 hours preceding inclusion. Intolerance or allergy to fluoxetine (Sandoz® 20 mg pill) Severe swallowing disorders preventing oral administration of the treatment Planned carotid surgery Pregnant or breast‐feeding woman Hepatic failure (TGO and TGP > 2N); severe renal failure (creatinine > 180micromol/l) Concomitant severe disease not allowing follow‐up Participation to another therapeutic study Contraindication to MRI and TMS Withdrawal criteria: not stated
Interventions	Experimental: fluoxetine; 1 pill of 20 mg/day, during 3 months Comparator: placebo of fluoxetine; 1 pill of 20 mg/day, during 3 months
Outcomes	Primary outcome: Slope of the curve of recruitment of the MEPs at 3 months. Secondary outcomes recorded at 3 and 6 months: Slope of recruitment of the MEPs (effect of a first dose of fluoxetine on the slope of recruitment of the MEPs) Slope of recruitment of the MEPs (persistence of fluoxetine effect on the slope of recruitment of the MEPs to month 6) Index finger force control in paretic hand In index finger force control in non‐paretic hand
Funding source	Not stated
Notes	No published data, unpublished data say 6 patients, none of whom died, so we have used this information Dates study conducted: February 2014 to August 2015 Declarations of Interest: none reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No information available
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information available
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No information available
Selective reporting (reporting bias)	Unclear risk	No information available
Other bias	Unclear risk	No information available