| Methods |
Study type: interventional (clinical trial)
Actual enrolment: 404
Allocation: randomised
Intervention model: parallel assignment
Masking: single (outcomes assessor)
Primary purpose: prevention |
| Participants |
Country: China
Setting: inpatient
At randomisation numbers allocated: N = 404
Experimental group: fluoxetine n = 202
Comparator group n = 202
% male: 70.5%
Age: Experimental: 61.14 ± 10.48; Comparator 62.72 ± 11.86
Subtype of stroke: unclear
Severity of stroke NIHSS score at baseline:
Experimental: Median 6 (IQR 4, 8)
Comparator: Median 5 (IQR 3, 8)
Time since stroke onset: mean days, fluoxetine 4.28 ± 1.89; placebo 4.08 ± 2.15
Inclusion criteria
ICD‐10 diagnostic criteria for acute cerebral infarction Age 18 to 80 years within 1 week of stroke onset Written informed consent by participants or legal representatives
Exclusion criteria
Coma History of stroke Pregnant or breast feeding Self‐injury, suicidal intention or depression and need for antidepressants History of peptic ulcer or gastritis Life‐threatening illness (e.g. cardiac insufficiency, malignancy) Use of antidepressants over previous 3 months Use of benzodiazepines over previous 2 weeks Allergic Enrolled in another interventional clinical research trial within previous 3 months
Withdrawal criteria
Violation of randomisation or blinding rules during the follow‐up Serious adverse reactions, such as anaphylactic shock Serious infections or medical complications. Antidepressants use Self‐injury, suicidal intention or depression and need for antidepressants Withdrawal from the study (participant or legal relatives)
|
| Interventions |
Experimental: 20 mg of fluoxetine a day for 90 days and conventional therapy
Comparator: conventional therapy |
| Outcomes |
Recurrence rate of cerebral infarction within 3 years Improvement of NIHSS, hypertension, diabetes, hyperlipids at day 90 |
| Notes |
ChiCTR‐TRC‐12002078
xuanyi_guo@163.com |
