Inflammation and Post-Stroke Depression



Status:Active, not recruiting
Conditions:Depression, Neurology
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:July 2013
End Date:December 2015

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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.

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.

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
We found this trial at
1
site
New Brunswick, New Jersey 08901
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New Brunswick, NJ
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