NCT00177424.

Study characteristics
Methods	Study type: interventional (clinical trial) Primary purpose: prevention
Participants	Number of participants: unclear Country: USA Setting: inpatient At randomisation number allocated: unclear % male: unclear Age: unclear Subtype of stroke: unclear Severity of stroke: unclear Time since stroke onset: unclear Inclusion criteria Age > 40 years old Ischaemic stroke within 3 months of study entry Admitted to a University of Pittsburgh Medical Center hospital for acute inpatient treatment or rehabilitation of stroke English‐speaking Women willing to use an effective form of birth control throughout the study Exclusion criteria Major depressive episode (DSM‐IV‐TR criteria) History of any bipolar disorder Psychotic or history of a psychotic disorder Alcohol or substance abuse or dependence (DMS‐IV TR criteria) within 3 months of study entry Current treatment with antidepressant medication for any reason (e.g. anxiety disorder, neuropathic pain) Primary haemorrhagic stroke Language impairment severe enough to prevent assessment CNS disease other than prior stroke or psychiatric illness (e.g. head trauma, multiple sclerosis, HIV with CNS involvement) Pulse < 50 or > 100 beats per minute Significant hyponatraemia (Na < 130 meq) Current hypothyroid state Medically unstable including symptoms of delirium History of sensitivity to sertraline Pregnant or breastfeeding
Interventions	Experimental: sertraline 12.5 mg/d for 3 days, increased to 25 mg/d for 4 days, then 50 mg/day for 7 days, then increased to 75 mg/day. Target dose = 75 mg per day for the remainder of participation in the study Comparator: matched placebo
Outcomes	Primary outcome collected at 12 months Major depression at 12 months Secondary outcomes collected at 12 months: Severity of depressive symptoms post‐stroke as measured by the HDRS Level of disability as measured by the FIM
Funding source	None stated
Notes	Terminated (recruitment goals could not be met). Last update 27 June 27 2014
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information to permit judgement
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Insufficient information to permit judgement
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgement
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Insufficient information to permit judgement
Selective reporting (reporting bias)	Unclear risk	Insufficient information to permit judgement
Other bias	Unclear risk	Insufficient information to permit judgement