Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208117
Status:
TERMINATED
Last Update Posted:
2012-05-31
First Post:
2005-09-15
Brief Title:
A Trial of Inflammatory Markers Depressive Symptoms and Heart Disease
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
A Randomized Controlled Trial of Inflammatory Markers Depressive Symptoms and Heart Disease
Status:
TERMINATED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to enroll subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHIME
Brief Summary:
The purpose of this study is to examine the relationship between depressive symptoms and markers of inflammation two predictors of heart disease
Detailed Description:
Depressive symptoms and inflammatory markers have both been proposed as measures that indicateprecede coronary artery disease CAD However no controlled research study has tested the impact of these two candidate CAD risk factors within the same design to see the directionality of their influence This study will explore if simvastatin reduces depressive symptoms and if sertraline reduces C-Reactive protein CRP Additionally the recruitment process will help determine the feasibility of a larger trial powered for significance testing Three hundred and seventy-five participants will be consented and screened for this study We expect forty-two otherwise healthy outpatients to have both elevated symptoms and high CRP levels and be willing to be randomly assigned to sertraline an antidepressant simvastatin a drug with anti-inflammatory properties or a placebo for 8 weeks Depressive symptoms and inflammatory indicators will be assessed before treatment screening and baseline mid-treatment after 4 weeks post-treatment after 8 weeks and a follow-up visit after 12 weeks using blood tests and depression interviews We expect that both inflammation and depressive symptoms may be reduced by both medications but the number of subjects needed to test this hypothesis is not yet known Hence this pilot study will be conducted Knowledge about the inter-dependency of these two CAD risk factors allows the most promising future observationalintervention studies to be designed and conducted
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