Clinical trial NCT02368145: Inflammation and Post-Stroke Depression
Official title: Inflammation and Post-Stroke Depression
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Acute Stroke
Keywords: stroke
acute stroke
post stroke depression
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2015-02-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with acute iechemic stroke

Brief summary: This study is being done to see if there is a relationship between stroke, post-stroke depression, and measures of inflammatory and/or stress compounds in the blood. Brain injury, as caused by stroke, leads to an inflammatory response in the brain which in turn can influence inflammatory and stress responses in other parts of the body outside of the brain. These responses can be measured by analyzing various substances in the blood and in the white blood cells. The investigators will measure these substances (cytokines, glucocorticoids) and compare them to the absence, presence, or degree of depression that the investigators will determine by neurological and psychological testing. The investigators will be drawing blood for this study on admission, at or around day 3, at or around day 7 and at or around day 90, which is not part of routine stroke care. The investigators will be asking subjects to participate in answering question/scales on these same days, some of these questionnaires are also not part of routine stroke care. Standard stroke care is being done other than blood drawing/participating in answering questions/scales. Approximately 25 people will be enrolled over one year.

Detailed description: Depression is a common long-term outcome of acute ischemic stroke (AIS), and can impede recovery, increase stroke recurrence, and influence mortality from stroke. Based on literature reviewed below, the investigators propose the novel over-arching hypothesis: that post-stroke depression (PSD) occurs in patients who show elevated production of proinflammatory immune cytokines during and/or after stroke, and at the same time present with reduced sensitivity to the immunosuppressive effects of glucocorticoids, which otherwise would be expected to have down-regulated cytokine production.

Eligibility criteria: Inclusion Criteria:

* The subjects will be male and female patients with acute ischemic stroke of the brain. Vascular risk factors, including diabetes, hypertension, and coronary artery disease, are expected to be common, and will be recorded in the Source Documents (appendix). Patients will be included if:

  * Aged ≥ 18 years of age
  * Neuroimaging or clinical symptoms are consistent with an acute ischemic stroke (AIS)
  * There are no alternative explanations for symptoms (eg. tumor, witnessed seizure, history of complicated migraine headache, hypoglycemia \[blood sugar (BS) \< 50 mg/dL\] or hyperglycemia (BS \> 400 mg/dL)
  * Subject is able to be enrolled and have blood samples drawn (Note: inability to provide a sample within 48 hours does not preclude inclusion if consent is provided after this time and patient can provide blood at subsequent time points (see Table)
  * Subject is able to provide informed consent for participation in this research study

Exclusion Criteria:

* • Other known severe/terminal illness which limits life expectancy to \< 90 days, sepsis, disseminated intravascular coagulopathy (DIC), infective endocarditis, metastatic cancer, or cerebral vasculitis

  * Current diagnosis of or treatment for major depressive disorder
  * Women who are pregnant at the time of stroke, since pregnancy alters inflammatory markers
  * Communication problems due to aphasia at visit 2, inability to speak English
  * History of substance abuse and other relevant psychiatric conditions
  * Autoimmune, current or recent infection, hematological disorders, use of immune modulating drugs

Primary outcomes:
measure: • The analysis of the presence of specific inflammatory markers
timeFrame: 90 days
measure: presence of depression in people with ischemic stroke
timeFrame: 90 days
Secondary outcomes:
measure: Measurement and identification stroke location
timeFrame: 90 days
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers, The State University
state: New Jersey
Study officials:
affiliation: Rutgers University
name: James S McKinney, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers University
name: Alexander Kusnecov, PhD
role: STUDY_DIRECTOR
References: