Omega-3 Fatty Acids to Improve Depression and Reduce Cardiovascular Risk Factors
|Cardiovascular Diseases Depression Heart Diseases Myocardial Infarction Angina, Unstable||Drug: Sertraline/omega-3 Drug: Sertraline/Corn Oil||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Omega-3 for Depression and Other Cardiac Risk Factors|
- Beck Depression Inventory-II [ Time Frame: Measured at Baseline and 10 weeks ]Beck Depression Inventory-II scores on a scale of 0 to 63, minimum score equals 0 maximum score equals 63. Higher value represents a worse outcome. Baseline scores are compared to scores after treatment.
|Study Start Date:||February 2005|
|Study Completion Date:||November 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
|Active Comparator: Sertraline/omega-3 supplement||
Sertraline (50 mgs) plus omega-3 (2 grams)
|Placebo Comparator: Sertraline/corn oil||
Drug: Sertraline/Corn Oil
Sertraline (50 mgs) plus corn oil (2 grams) (placebo)
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116857
|United States, Missouri|
|St. Louis, Missouri, United States, 63108|
|Study Chair:||Robert M. Carney, PhD||Washington University School of Medicine|