To determine the effects of omega-3 fatty acid augmentation of sertraline on depression and cardiac endpoints after myocardial infarction.

Condition	Intervention
Cardiovascular Diseases Depression Heart Diseases Myocardial Infarction Angina, Unstable	Drug: sertraline

Further Study Details: 

BACKGROUND: Depression is a risk factor for morbidity and mortality after acute myocardial infarction (MI) and unstable angina. Two recent clinical trials (sertraline vs. placebo, sertraline plus cognitive therapy vs. 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 fatty acids (FAs) have been shown to augment the efficacy of antidepressants for major depression and to improve several cardiac risk factors. However, these findings have evolved 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 seventy patients who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for a current major depressive episode and who score 19 or higher on the Hamilton Rating Scale for Depression 3-4 months after an acute MI or unstable angina 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 sertraline plus omega-3 or sertraline plus placebo for ten weeks. At baseline and again after ten weeks, the subjects will complete 1) assessments of depression and psychosocial functioning; 2) 24 hour ECG 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.

Genders Eligible for Study:  Both

Criteria

An estimated 170 subjects who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for a current major depressive episode and who score 19 or higher on the Hamilton Rating Scale for Depression 3-4 months after an acute myocardial infarction or unstable angina.

Please refer to this study by ClinicalTrials.gov identifier  NCT00116857

Missouri
      Washington University, St. Louis,  Missouri,  63108,  United States; Recruiting

Study chairs or principal investigators

Robert Carney,  Washington University School of Medicine   

Study ID Numbers:  186
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 30, 2005
ClinicalTrials.gov Identifier:  NCT00116857
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-05