Omega-3 for Depression and Other Cardiac Risk Factors - 2

Phase 2

Completed

• Conditions: Depression
• Interventions: Drug: Omega-3 supplement; Drug: Placebo

• Registration Number: NCT02021669
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-27
• Study Start: 2014-05-14
• Primary Completion: 2018-09-13
• Study Completion: 2018-09-13
• Results First Submitted: 2019-07-12
• Results First Submitted QC: 2019-07-12
• Status Verified: 2019-08
• Results First Posted: 2019-08-06
• Last Update Submitted: 2019-08-23
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Documented coronary heart disease
• Diagnosis of major depression based on structured interview

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Exclusion Criteria

• Moderate to severe cognitive impairment
• Meets DSM-5 criteria for depressive disorder due to a general medical condition or medication
• Major Axis I psychiatric disorder other than unipolar depression or an anxiety disorder, a high risk of suicide, or current substance abuse other than tobacco;
• Not expected to survive one year or physically unable to tolerate the study protocol
• Known sensitivity to sertraline or omega-3, or an allergy to fish oil or shellfish
• Taking an antidepressant or an omega-3 supplement at baseline
• Exempted by their cardiologist or primary care physician
• Refuses to provide informed consent
• Participating in a competing protocol or trial

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omega-3 supplement	Omega-3 supplement	Two grams of the EPA form of omega-3 plus 50 mg of sertraline daily for 10 weeks
Placebo	Placebo	Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory-II (BDI-II)	Change from baseline to 10 weeks (post-treatment)	The BDI-II is a 21-item self-report inventory of depression symptoms. The minimum and maximum values for the BDI-II are (0-63). For both instruments, the higher the scores, the greater the severity of depression.

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HAM-D, 17)	Change from baseline to 10 weeks (post-treatment)	The HAM-D, 17 is a 17-item, observer-rated measure of depression symptoms. The minimum and maximum values for the HAM-D, (0-52). For both instruments, the higher the scores, the greater the severity of depression.

Trial Locations

Locations (1)

Washington University Medical Center; 🇺🇸 Saint Louis, Missouri, United States