A Phase 3 interventional study of Sertraline/omega-3 and Sertraline/Corn Oil in Cardiovascular Diseases, Depression and Heart Diseases, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-12.
Sponsored by Washington University School of Medicine · Phase 3, Interventional, and Treatment
This study will determine the effects of omega-3 fatty acid (FA) augmentation of sertraline on depression and cardiac endpoints after myocardial infarction (MI).
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 122 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
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Exclusion Criteria:
Drug: Sertraline/omega-3
Drug: Sertraline/Corn Oil
Sertraline (50 mgs) plus omega-3 (2 grams)
Sertraline (50 mgs) plus corn oil (2 grams) (placebo)
Beck Depression Inventory-II
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.
Time frame: Measured at Baseline and 10 weeks
| Milestone | Sertraline Plus Omega-3 Supplement | Sertraline/Corn Oil |
|---|---|---|
| Started | 62 | 60 |
| Completed | 59 | 56 |
| Not completed | 3 | 4 |
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.
| units on a scale | Sertraline Plus Omega-3 Supplement | Sertraline/Corn Oil |
|---|---|---|
| Beck Depression Inventory-II | 16.1 ± 10.2 | 14.8 ± 9.7 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sertraline Plus Omega-3 Supplement | — | 0/62 (0%) | 0/62 (0%) |
| Sertraline/Corn Oil | — | 0/60 (0%) | 0/60 (0%) |
| Age, Categorical(Participants) | Sertraline Plus Omega-3 Supplement | Sertraline/Corn Oil | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 50 | 48 | 98 |
| >=65 years | 12 | 12 | 24 |
| Age Continuous(years) | Sertraline Plus Omega-3 Supplement | Sertraline/Corn Oil | Total |
|---|---|---|---|
| Mean | 58.1 ± 9.4 | 58.6 ± 8.5 | 58.4 ± 9.0 |
| Sex: Female, Male(Participants) | Sertraline Plus Omega-3 Supplement | Sertraline/Corn Oil | Total |
|---|---|---|---|
| Female | 22 | 19 | 41 |
| Male | 40 | 41 | 81 |
| Region of Enrollment(participants) | Sertraline Plus Omega-3 Supplement | Sertraline/Corn Oil | Total |
|---|---|---|---|
| United States | 62 | 60 | 122 |
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine