| Eligibility |
Inclusion Criteria:
1. 1. Men and women aged 50 to 86 years;
2. Able to fully comprehend and sign an informed consent form;
3. Diagnosis of stroke/TIA prior to study entrance and evidence of ischemic infarct
and/or lacunar infarcts on MRI (defined as sharply demarcated hypointense lesions
<20mm on T1-weighted images with corresponding hypointense lesions with hyperintense
rim on FLAIR) and/or deep Cerebral Microbleeds (CMB) (defined as round hypointense
lesions on T2-weighted gradient echo-images with a diameter < 10 mm in neuroimaging.
4. Meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5)
diagnostic criteria for major depressive episode that developed up to 12 months after
the documented stroke/TIA.
5. Able to comply with scheduled visits, treatment plan, and other trial procedures;
6. Treatment with other antidepressants is allowed but subjects will be asked not to
change their regular treatment regime during the trial.
Exclusion Criteria:
7. Hemorrhages and cerebral edema (e.g., subarachnoid haemorrhage, intracerebral
hemorrhage, subdural hematoma, epidural hematoma)
8. Patients in a state of coma or with severe disturbance of consciousness, aphasia,
agnosia, or deafness that subsequently affects expression and communication.
9. Significant acute medical illness including: drug overdose, severely disturbed liver,
kidney or lung function, anemia, hypothyroidism, or uncontrolled diabetes.
10. Significant acute neurologic illness including: impaired consciousness, Parkinson's
disease, Huntington's chorea, progressive supranuclear paralysis, brain tumor,
subdural hematoma, multiple sclerosis, hydrocephalus, Binswanger's disease, or severe
aphasia
11. Patients diagnosed with dementia or major neurocognitive disorder as defined by
DSM-5at screening, or other neurological conditions that might dominate the clinical
picture (multiple sclerosis, Parkinson's disease, epilepsy, Huntington's chorea,
progressive supranuclear paralysis, brain tumor, subdural hematoma, multiple
sclerosis, hydrocephalus, Binswanger's disease, etc.)
12. Subject has a history of human immunodeficiency virus (HIV), hepatitis B surface
antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically
active liver disease, or elevated hepatic transaminases or bilirubin, or tests
positive for HIV at Screening.
13. History of renal insufficiency or serum creatinine over 1.6;;
14. Subject has a current or past diagnosis of bipolar or related disorders, intellectual
disability, cluster B personality disorder (e.g., borderline personality disorder,
antisocial personality disorder, histrionic personality disorder, and narcissistic
personality disorder), psychotic disorder, schizophrenia, PTSD , and substance/alcohol
use disorders other than nicotine in the past year (including barbiturates, methadone,
opiates, cocaine, cannabinoids, and amphetamine/ methamphetamine).
15. Subject has suicidal ideation with intent to act during the screening phase or on Day
1 per investigator's clinical judgment, or has a history of suicidal behavior within
the past year; or subject has homicidal ideation/intent at Screening or on Day 1.
16. Subject has a history of malignancy within 5 years before screening (exceptions are
squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or
malignancy that in the opinion of the investigatoris considered cured with minimal
risk of recurrence).
17. Subject has known allergies, hypersensitivity, intolerance, or contraindication to
Maraviroc or its excipients.
18. Subject has received an investigational drug (including investigational vaccines) or
used an invasive investigational medical device within 60 days before the planned
first dose of study drug or is currently enrolled in an investigational study.
19. Subject is a woman who is pregnant, breast-feeding, or planning to become pregnant
while enrolled in this study or within 3 months after the last dose of study drug.
20. Subject has any condition for which, in the opinion of the investigator, participation
would not be in the best interest of the subject (e.g., compromise the well-being) or
that could prevent, limit, or confound the protocol-specified assessments.
21. Subject has had major surgery, (e.g., requiring general anesthesia) within 2 weeks
before screening, or will not have fully recovered from surgery, or has surgery
planned during the time the subject is expected to participate in the study.
22. Use of drugs with possible interactions with Maraviroc.
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