Trial Outcomes & Findings for Inflammation and Post-Stroke Depression (NCT NCT02368145)
NCT ID: NCT02368145
Last Updated: 2026-07-16
Results Overview
• 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.
COMPLETED
25 participants
90 days
2026-07-16
Participant Flow
Participant milestones
| Measure |
All Participants (no Treatment)
No participants in this study received a treatment or intervention.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
Visit A
|
25
|
|
Overall Study
Visit B
|
25
|
|
Overall Study
Visit C
|
22
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inflammation and Post-Stroke Depression
Baseline characteristics by cohort
| Measure |
All Participants (no Treatment)
n=25 Participants
No participants in this study received a treatment or intervention.
|
|---|---|
|
Age, Continuous
|
57 years
n=9 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Those who completed all 3 visits.
• 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.
Outcome measures
| Measure |
All Participants (no Treatment)
n=22 Participants
No participants in this study received a treatment or intervention.
|
|---|---|
|
• Measurement of Inflammatory Cytokines IL-1beta, TNFalpha and IL-6 Blood Plasma
No detectable concentrations of any cytokine (IL-1, TNF or IL-6)
|
16 Participants
|
|
• Measurement of Inflammatory Cytokines IL-1beta, TNFalpha and IL-6 Blood Plasma
Detectable concentration of IL-6, but no IL-1 or TNF
|
6 Participants
|
PRIMARY outcome
Timeframe: 90 daysContinuous 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.
Outcome measures
| Measure |
All Participants (no Treatment)
n=22 Participants
No participants in this study received a treatment or intervention.
|
|---|---|
|
Presence of Depression in People With Ischemic Stroke
Depressed
|
3 Participants
|
|
Presence of Depression in People With Ischemic Stroke
Non-Depressed
|
19 Participants
|
SECONDARY outcome
Timeframe: Day of admissionPopulation: Participants categorized as either depressed or non-depressed at 90 days.
Localization will occur through neuroimaging by either CT or MRI
Outcome measures
| Measure |
All Participants (no Treatment)
n=22 Participants
No participants in this study received a treatment or intervention.
|
|---|---|
|
Measurement and Identification Stroke Location
Depressed · Right Hemisphere Lesion
|
1 Participants
|
|
Measurement and Identification Stroke Location
Depressed · Bilateral Damage
|
0 Participants
|
|
Measurement and Identification Stroke Location
Depressed · Left Hemisphere Lesion
|
2 Participants
|
|
Measurement and Identification Stroke Location
Non-Depressed · Left Hemisphere Lesion
|
8 Participants
|
|
Measurement and Identification Stroke Location
Non-Depressed · Right Hemisphere Lesion
|
9 Participants
|
|
Measurement and Identification Stroke Location
Non-Depressed · Bilateral Damage
|
2 Participants
|
Adverse Events
All Participants (no Treatment)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place