Omega-3 for Depression and Other Cardiac Risk Factors - 2 (Omega-3(2))
The purpose of this 10 week randomized, placebo-controlled, double-blind clinical trial is to determine whether antidepressant augmentation with two grams of EPA omega-3 per day is superior to antidepressant therapy alone for major depression in patients with coronary heart disease (CHD).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Omega-3 for Depression and Other Cardiac Risk Factors-2|
- Beck Depression Inventory - 2 (BDI-2) [ Time Frame: Change from baseline to 10 weeks (post-treatment) ] [ Designated as safety issue: No ]The BDI-2 is a 21-item self-report inventory of depression symptoms.
- Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: Change from baseline to 10 weeks (post-treatment) ] [ Designated as safety issue: No ]The HAMD-17 is a 17-item, observer-rated measure of depression symptoms.
- Heart Rate Variability (HRV) [ Time Frame: Change from baseline to 10 weeks (post-treatment) ] [ Designated as safety issue: No ]Very low frequency (VLF) power and other indices of HRV are indicators of cardiovascular autonomic function.
- Interleukin-6 (IL-6) [ Time Frame: Change from baseline to 10 weeks (post-treatment) ] [ Designated as safety issue: No ]IL-6 is a pro-inflammatory cytokine.
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||April 2018 (Final data collection date for primary outcome measure)|
Experimental: Omega-3 supplement
Two grams of the EPA form of omega-3 plus 50 mg of sertraline daily for 10 weeks
Drug: Omega-3 supplement
Two grams of the EPA form of omega-3 daily and 50 mgs of sertraline daily for 10 weeks
Other Name: EPA Plus Minami Nutrition
Placebo Comparator: Placebo
Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.
Depression increases the risk for cardiac morbidity and mortality 2-4 fold in patients with coronary heart disease (CHD). Recent clinical trials have tested standard treatments for comorbid depression in patients with CHD, and some have evaluated their effects on cardiac morbidity and mortality. Most of these trials have shown that standard treatments have only modest effects on depression and have produced relatively small differences between the intervention and control condition. Consequently, they have been unable to determine whether effective treatment of depression can improve cardiac outcomes. Low dietary intake and low plasma phospholipid or erythrocyte levels of two omega-3 fatty acids(FAs), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are associated with depression and other cardiac risk markers. There is growing evidence from small psychiatric trials that the efficacy of standard antidepressants can be improved by coadministration of an omega-3 FA formulation containing at least 1 gram of EPA. The purpose of the proposed research is to determine whether antidepressant augmentation with this omega-3 formulation is superior to antidepressant therapy alone for major depression in patients with CHD. The proposed study is a randomized, placebo-controlled, double-blind clinical trial. Consenting patients with established coronary heart disease who meet the Diagnostic Statistical Manual (DSM)-5 criteria for a major depressive episode will undergo a baseline evaluation and then be randomly assigned to receive either 50 mg/day of sertraline plus omega-3 FA or 50 mg/day of sertraline plus placebo for 10 weeks. At baseline and after 10 weeks, participants will complete assessments of depression, 24 hour ambulatory ECG monitoring to measure 24 hour heart rate and heart rate variability, and blood draws to measure procoagulant and proinflammatory markers and blood levels of EPA, DHA, other omega-3 FAs, and the omega-6 FAs. If sertraline plus this omega-3 formulation significantly reduces depression compared to sertraline plus placebo, and if it improves or at least does not worsen other cardiovascular risk markers, this study will provide a strong basis for proposing a multicenter clinical trial of sertraline augmented with omega-3 to determine whether treatment of depression can improve survival in patients with CHD and depression.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02021669
|Contact: Patricia Herzing, RNemail@example.com|
|Contact: Kim Metze, BAfirstname.lastname@example.org|
|United States, Missouri|
|Washington University Medical Center||Recruiting|
|St Louis, Missouri, United States, 63108|
|Contact: Robert M Carney, PhD 314-286-1313 email@example.com|
|Contact: Patricia Herzing, RN 314-286-1360 firstname.lastname@example.org|
|Principal Investigator: Robert M Carney, PhD|
|Principal Investigator:||Robert M Carney, PhD||Washington University School of Medicine|