Ignite Creation Date:
2024-05-06 @ 12:38 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01625845
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2012-06-19
Brief Title:
Anti-INFLammatory to Address Mood and Endothelial Dysfunction INFLAMED
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Targeting Systemic Inflammation to Concurrently Treat Late-Life Depression and Reduce Coronary Artery Disease Risk
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INFLAMED
Brief Summary:
The objective of this clinical trial is to evaluate whether an anti-inflammatory medication pentoxifylline reduces depressive symptoms and improves artery function Participants in this trial will be older primary care patients 60 years and up who are depressed but do not have a history of cardiovascular disease Half of these patients will receive pentoxifylline and half will receive placebo In addition participants in both arms will receive an evidence-based psychological treatment called Beating the Blues which is a computerized cognitive behavioral treatment program for depression The investigators will use questionnaires to assess change in depressive symptoms and an ultrasound test to measure change in artery function from pre- to post-treatment It is hypothesized that patients who receive pentoxifylline will show greater improvements in both depression and artery function than patients who receive placebo
Detailed Description:
Cardiovascular disease is the leading cause of death and depression is the leading cause of disability in the United States Previous research suggests that systemic inflammation may play an important role in the development of both depression and cardiovascular disease Therefore Aim 1 of this study is to examine whether adding an anti-inflammatory medication pentoxifylline to standard depression treatment cognitive-behavioral therapy improves both depressive symptoms and endothelial dysfunction a sign of early cardiovascular disease Aim 2 is to evaluate candidate mediators of treatment effects by examining whether reductions in multiple markers of systemic inflammation account for treatment-related improvements in depressive symptoms and endothelial dysfunction To achieve these aims a clinical trial of older depressed primary care patients free of cardiovascular disease is being conducted Patients will be randomized to one of two groups a standard depression treatment a cognitive-behavioral treatment program plus pentoxifylline or standard depression treatment plus placebo The treatment phase of the study will be 12 weeks At baseline 6 weeks and 12 weeks patients will undergo assessments of depressive symptoms various inflammatory markers and endothelial function Our index of endothelial function is brachial artery flow-mediated dilation a noninvasive measure of endothelial function Demonstrating that medications targeting systemic inflammation are effective for concurrently treating late-life depression and reducing CAD risk would place anti-inflammatory approaches in the collection of depression treatment strategies as well as CAD prevention strategies of the primary care provider This change to clinical practice should result in improved management of both late-life depression and cardiovascular risk which in turn would reduce disability CAD morbidity and mortality among older adults
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1737 | OTHER | Indiana Clinical Research Center | httpsreporternihgovquickSearchR24MH080827 |
| R24MH080827 | NIH | None | None |