Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116857
Status:
COMPLETED
Last Update Posted:
2012-09-12
First Post:
2005-06-30
Brief Title:
Omega-3 Fatty Acids to Improve Depression and Reduce Cardiovascular Risk Factors
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Omega-3 for Depression and Other Cardiac Risk Factors
Status:
COMPLETED
Status Verified Date:
2012-09
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:
None
Brief Summary:
This study will determine the effects of omega-3 fatty acid FA augmentation of sertraline on depression and cardiac endpoints after myocardial infarction MI
Detailed Description:
BACKGROUND
Depression is a risk factor for morbidity and mortality following an acute MI and unstable angina Two recent studies sertraline versus placebo and sertraline plus cognitive therapy versus usual care reported only modest reductions in depression following an acute MI or unstable angina and many treated patients remained depressed Neither study reported better medical outcomes in the treated patients Earlier studies found that even subclinical depression increases the risk of mortality in cardiac patients Thus more effective treatments are needed to eliminate depression and improve medical outcomes in patients following an acute MI or unstable angina Omega-3 FAs have been shown to augment the efficacy of antidepressants for major depression and to improve several cardiac risk factors However these findings have been shown in separate lines of research No previous study has investigated whether omega-3 FAs can simultaneously improve depression and reduce cardiovascular risk factors in post-MI patients
DESIGN NARRATIVE
One hundred fifty patients who meet the Diagnostic and Statistical Manual of Mental Disorders DSM-IV criteria for a current major depressive episode and who score 15 or higher on the Beck Depression Inventory II with a history of acute MI unstable angina or other cardiac event will be enrolled in a randomized double-blind placebo-controlled trial of omega-3 augmentation of sertraline The participants will be randomly assigned to receive either sertraline plus omega-3 or sertraline plus placebo for 10 weeks At baseline and again after ten weeks the subjects will complete the following 1 assessments of depression and psychosocial functioning 2 24-hour electrocardiogram monitoring for heart rate variability analysis and 3 blood draws to measure procoagulant and proinflammatory markers and plasma levels of sertraline and omega-3 If this study shows that omega-3 reduces depression and improves cardiovascular disease markers there will be a basis for proposing a larger clinical trial to determine whether it can also improve survival after hospitalization for acute MI or unstable angina
Depression is a risk factor for morbidity and mortality following an acute MI and unstable angina Two recent studies sertraline versus placebo and sertraline plus cognitive therapy versus usual care reported only modest reductions in depression following an acute MI or unstable angina and many treated patients remained depressed Neither study reported better medical outcomes in the treated patients Earlier studies found that even subclinical depression increases the risk of mortality in cardiac patients Thus more effective treatments are needed to eliminate depression and improve medical outcomes in patients following an acute MI or unstable angina Omega-3 FAs have been shown to augment the efficacy of antidepressants for major depression and to improve several cardiac risk factors However these findings have been shown in separate lines of research No previous study has investigated whether omega-3 FAs can simultaneously improve depression and reduce cardiovascular risk factors in post-MI patients
DESIGN NARRATIVE
One hundred fifty patients who meet the Diagnostic and Statistical Manual of Mental Disorders DSM-IV criteria for a current major depressive episode and who score 15 or higher on the Beck Depression Inventory II with a history of acute MI unstable angina or other cardiac event will be enrolled in a randomized double-blind placebo-controlled trial of omega-3 augmentation of sertraline The participants will be randomly assigned to receive either sertraline plus omega-3 or sertraline plus placebo for 10 weeks At baseline and again after ten weeks the subjects will complete the following 1 assessments of depression and psychosocial functioning 2 24-hour electrocardiogram monitoring for heart rate variability analysis and 3 blood draws to measure procoagulant and proinflammatory markers and plasma levels of sertraline and omega-3 If this study shows that omega-3 reduces depression and improves cardiovascular disease markers there will be a basis for proposing a larger clinical trial to determine whether it can also improve survival after hospitalization for acute MI or unstable angina
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 |
|---|---|---|---|
| R01HL076808 | NIH | None | httpsreporternihgovquickSearchR01HL076808 |