StrokeNCT02368145
Inflammation and Post-Stroke Depression
An observational study of Stroke and Acute Stroke, run by Alexander Kusnecov, Ph.D. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute Stroke
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jun 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with acute iechemic stroke
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers, The State University
New Brunswick, New Jersey, 08901
About this study
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.
Read the 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.
- Conditions
- Stroke, Acute Stroke
- Keywords
- stroke, acute stroke, post stroke depression
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
• Measurement of Inflammatory Cytokines IL-1beta, TNFalpha and IL-6 Blood Plasma
- 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.
Measured: 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.
Measured: 90 days
Secondary outcomes (1)
Measurement and Identification Stroke Location
Localization will occur through neuroimaging by either CT or MRI
Measured: Day of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startJul 2013
- Primary completionDec 2014
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexander Kusnecov, Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexander Kusnecov, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- James S McKinney, MD, Principal investigator, Rutgers UniversityAlexander Kusnecov, PhD, Study director, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368145
- Sponsor's protocol ID
- 2012001658
- Other IDs
- pc 62-12
- Status last verified
- Jun 2026
- First submitted
- 4 Nov 2014
- Last updated
- 16 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation and Post-Stroke Depression
- ClinicalTrials.gov ID
- NCT02368145
- Acronym / sponsor ID
- 2012001658
- Conditions
- Stroke, Acute Stroke
- Keywords
- stroke, acute stroke, post stroke depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Alexander Kusnecov, Ph.D.University, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Feb 2015 (estimated)
- Results
- Posted 16 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with acute iechemic stroke
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (6 listed)
- • Other known severe/terminal illness which limits life expectancy to < 90 days, sepsis, disseminated intravascular coagulopathy (DIC), infective endocarditis, metastatic cancer, or cerebral vasculitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
• 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.
1 secondary outcome
Measurement and Identification Stroke Location
Time frame: Day of admission
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James S McKinney, MD principal investigator
Rutgers University
Alexander Kusnecov, PhD study director
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Acute Stroke, run by Alexander Kusnecov, Ph.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Measurement of Inflammatory Cytokines IL-1beta, TNFalpha and IL-6 Blood Plasma (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.