Guo 2015.

Methods	Study type: interventional (clinical trial) Actual enrolment: 300 Allocation: randomised Intervention model: parallel assignment Masking: single (outcomes assessor) Primary purpose: prevention
Participants	Country: China Setting: inpatient At randomisation numbers allocated: N = 300 Experimental group 1: fluoxetine immediately after enrolment n = 100 Comparator group 1: fluoxetine 7 days after enrolment n = 100 Comparator group 2: no fluoxetine n = 100 % male: unclear Age: Experimental, unclear; Comparator 1, unclear; Comparator 2, unclear Subtype of stroke: unclear Severity of stroke NIHSS score at baseline: unclear Experimental: unclear Comparator 1: unclear Comparator 2: unclear Time from stroke onset: within 1 week after onset of cerebral infarction Inclusion criteria: ICD‐10 diagnostic criteria for acute cerebral infarction Age 18 to 80 years First onset of stroke within 1 week NIHSS > 2 Stroke‐related impairment Informed consent by participants or legal representative Exclusion criteria: Coma Haemorhagic stroke Previous neurological impairment Use of antidepressants over previous 3 months Use of benzodiazepines over previous 2 weeks Self‐harm, suicidal ideation or need for antidepressants Abnormal liver enzymes or creatinine levels Gastrointestinal disorders affect drug absorption seriously Life‐threatening illness (e.g. malignancy) Allergic Mental health disorders Pregnant or breast feeding Allergic Enrolled in another interventional clinical research trial within previous 3 months Withdrawal criteria: Unblinding Serious adverse reactions e.g. anaphylactic shock Need for immediate stroke‐related surgery Complications Antidepressant use Self‐harm, suicidal intention, urgent need for antidepressants Withdrawal from the study
Interventions	Experimental: 20 mg of fluoxetine per day for 90 days given immediately after enrolment and conventional therapy of cerebral infarction Comparator 1: 20 mg of fluoxetine a day for 90 days given 7 days after enrolment and conventional therapy of cerebral infarction Comparator 2: no fluoxetine and conventional therapy of cerebral infarction
Outcomes	Primary outcome at days 15, 90 and 180 NIHSS score Secondary outcome at days 90 and 180 BI score
Notes	ChiCTR‐TRC‐15007658 xuanyi_guo@163.com Baseline demographic and clinical characteristics for each group not presented, but rather the baseline demographic and clinical characteristics for those completing the trial (i.e. a subset of all those randomised at baseline) are presented