Inflammation and Post-Stroke Depression

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.

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Key information

Conditions

Stroke Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rutgers, The State University

New Brunswick, New Jersey, 08901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

• Measurement of Inflammatory Cytokines IL-1beta, TNFalpha and IL-6 Blood Plasma

Time frame: 90 days
- Analysis of blood for the presence of Increased proinflammatory cytokines: IL-1beta, TNFalpha, IL-6. These were measured in blood plasma using enzyme-linked immunosorbent assays (ELISAs). Each cytokine was measured in a separate ELISA, and all cytokines were measured from the same plasma sample for each subject. All cytokine concentrations were expressed as pg/ml of plasma. These measures were conducted on three blood draws that were conducted at the time of subject recruitment (visit A; within 48 hrs of stroke onset), 7 days later (visit B: +/- 3 days), and finally at 90 days (visit C: +/- 7days) after recruitment. Criteria for inclusion in the study was an acute ischemic episode with sparing of language comprehension and ability to speak.
Presence of Depression in People With Ischemic Stroke

Time frame: 90 days

Continuous measures of clinician-rated depression severity and potential co-morbid anxiety will be measured with the Hamilton Depression and Anxiety Scales (Ham-A and Ham-D 46-48). These are widely-used and well-validated rating scales that have been used in a variety of patient populations, and will be supplemented for thoroughness with the Beck Depression Inventory. The presence and history of depression and anxiety disorders will be also be assessed using the Structured Diagnostic Interview for Axis I DSM-IV Disorders depression and anxiety modules (SCID) 49. The SCID is a diagnostic semi-structured interview designed to assess and diagnose mental illnesses as defined by the DSM-IV (American Psychiatric Association, 2000), which is the gold standard for diagnosis categorization in the United States.

Secondary outcomes

Measurement and Identification Stroke Location

Time frame: Day of admission

Localization will occur through neuroimaging by either CT or MRI

Sponsors and collaborators

Lead sponsor

Alexander Kusnecov, Ph.D.

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2016
First posted: Feb 20, 2015
Registry last updated: Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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