Inflammation and Post-Stroke Depression

NCT02368145 | Unknown

• 2 other identifiers: 2012001658pc 62-12
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Acute Stroke

Keywords

stroke; acute stroke; post stroke depression

Outcome Measures

Primary Outcomes (2)

• • The analysis of the presence of specific inflammatory markers

  • Analysis of blood for the presence of Increased proinflammatory cytokines measured in blood plasma and isolated peripheral blood mononuclear cells (PBMC),reduced sensitivity to the suppressive effects of the synthetic glucocorticoid, dexamethasone, on cytokine production and proliferation in stimulated PBMC cultures and high cortisol and ACTH levels

  90 days

• presence of depression in people with ischemic stroke

  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.

  90 days

Secondary Outcomes (1)

• Measurement and identification stroke location

  90 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with acute iechemic stroke

You may qualify if:

• 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 provide informed consent for participation in this research study

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexander Kusnecov, Ph.D.: lead

Study Sites (1)

Rutgers, The State University

New Brunswick, New Jersey, 08901, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood serum

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• James S McKinney, MD

  Rutgers University

  PRINCIPAL INVESTIGATOR

• Alexander Kusnecov, PhD

  Rutgers University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: February 20, 2015
• Study Start: July 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: November 3, 2015

Record last verified: 2015-11

Locations

US (1)