Inflammation and Post-Stroke Depression

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02368145

Enrollment

Registered

2015-02-20

Start date

2013-07-01

Completion date

2016-06-01

Last updated

2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Stroke, Stroke

Keywords

stroke, acute stroke, post stroke depression

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
• Measurement of Inflammatory Cytokines IL-1beta, TNFalpha and IL-6 Blood Plasma	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	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

Measure	Time frame	Description
Measurement and Identification Stroke Location	Day of admission	Localization will occur through neuroimaging by either CT or MRI

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJames S McKinney, MD

Rutgers University

STUDY_DIRECTORAlexander Kusnecov, PhD