Stroke
Conditions
Interventions
Test group:bupropion hydrochloride + conventional treatment
Placebo control group:Placebo contro + conventional treatment
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) The patients were clinically diagnosed as acute cerebral infarction. Patients with cerebral infarction who had received standard intravenous thrombolytic therapy after the onset of the disease don’t worsen after thrombolytic therapy, could also be included; (2) Age >=18 years old, gender unlimited; (3) 8<=NIHSS scale score <=15 when enrolled; (4) Muscle strength of the limbs rating level <= 3; (5) Patients hospitalized within 2-7 days of the onset of stroke; (6) Patients were able to independently engage in activities of daily living before the onset of this stroke (pre-onset mRS score <=1); (7) Subjects or guardian signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with cerebral infarction who have undergone endovascular mechanical thrombectomy after this episode; (2) Stroke and brain dysfunction caused by other non-vascular causes (such as primary brain tumors, brain metastases, subdural hematoma, brain trauma, etc.); (3) A history of dementia and mental illness other than depression; (4) Severe disturbance of consciousness: NIHSS item 1a score > 1, or unable to complete the examination due to visual, hearing, language expression and comprehension disorders; (5) Stroke due to other specific risk causes (i.e., atrial fibrillation, cerebral arteritis or artery dissection, migraine with aura/vasospasm, drug or alcohol abuse); (6) TIA, RIND or subarachnoid hemorrhage; (7) Combined with other nervous system diseases, such as Parkinson's, epilepsy, Alzheimer's disease, and central nervous system infection (such as AIDS, syphilis, etc.); (8) Patients who have already received or will receive physical therapies such as electroconvulsive therapy; (9) Severe hepatic and renal insufficiency: ALT or AST values >2 times the upper limit of normal, serum creatinine >2.0mg/dL or >176.8µmol/L; (10) Combined with severe lung diseases, such as lung cancer, tuberculosis, asthma, chronic obstructive pulmonary disease, pulmonary embolism, acute attack of chronic bronchitis, chronic pulmonary heart disease, pulmonary encephalopathy, acute bronchitis, emphysema, viral pneumonia, interstitial pneumonia, etc; (11) After aggressive antihypertensive treatment, hypertension remained uncontrolled: systolic blood pressure >=180mmHg or diastolic blood pressure >=100mmHg; (12) Severe blood glucose abnormalities: blood glucose 22.2mmol/L; (13) Any known clotting defects, such as INR > 1.7 or prothrombin time > 15 seconds with currently used vitamin K antagonists, In the past 48 hours, a direct thrombin inhibitor or a new oral anticoagulant NOAC (unless reversible by eidacezumab) or sensitivity laboratory test values exceeding the upper limit of normal (such as activated partial thromboplastin time (aPTT), International normalized ratio (INR), platelet count, thromboplastin time (TT), or Xa, as appropriate) have been used Factor activity assay), or an increase in aPTT above the upper limit of normal in the past 24 hours with heparin; (14) Platelet dysfunction or platelet counts < 100×10^9/L (but may include patients taking antiplatelet drugs); (15) Patients with other diseases affecting limb movement, and patients with limb movement dysfunction caused by claudication, osteoarthritis, rheumatoid arthritis, gouty arthritis, etc. before treatment may affect nerve function examination; (16) Patients who were unable to complete daily activities independently due to various diseases and physical weakness before the disease seriously affected the efficacy evaluation; (17) Unable to swallow drugs; (18) There is an allergy or contraindication to bupropion; (19) Currently using or used other antidepressants within the previous 3 months; (20) Patients have been treated with bupropion or other antidepressants since this onset of stroke; (21) Subjects who are pregnant or breastfeeding and who plan to become pregnant within 90 days; (22) Complicated with malignant tumor or serious disease, and the expected survival is less than 1 year; (23) Have participated in another clinical intervention study or are currently participating in another clinical intervention investigator within 3 months prior to randomization; (24) The
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with mRS score of 0-3 on day 90 of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with mRS score of 0-2 on the 30th, and 90th of treatment;Proportion of subjects with absolute NIHSS score decreased by = 4 compared to the baseline or with a score of 0-1 on the 7th, 30th, and 90th day of treatment;Change from baseline in the Hamilton Depression Rating Scale (HAMD-17) score at the 90th day of treatment;Change from baseline in limb muscle strength at 90 days of treatment;Change from baseline in the Fugl-Meyer Motor Scale (FMMS) score at the 90th day of treatment;EQ-5D score at the 90th day of treatment; | — |
Countries
China
Contacts
Public ContactPeng Xie
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed