Omega-3 Fatty Acids to Improve Depression and Reduce Cardiovascular Risk Factors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00116857|
Recruitment Status : Completed
First Posted : July 1, 2005
Results First Posted : September 12, 2012
Last Update Posted : September 12, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Depression Heart Diseases Myocardial Infarction Angina, Unstable||Drug: Sertraline/omega-3 Drug: Sertraline/Corn Oil||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Omega-3 for Depression and Other Cardiac Risk Factors|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||November 2009|
|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)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116857
|United States, Missouri|
|St. Louis, Missouri, United States, 63108|
|Study Chair:||Robert M. Carney, PhD||Washington University School of Medicine|