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

NCT ID: NCT02021669

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-14
• Study Completion Date: 2018-09-13

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Omega-3 supplement

Two grams of the EPA form of omega-3 plus 50 mg of sertraline daily for 10 weeks

Group Type: EXPERIMENTAL

Omega-3 supplement

Intervention Type: DRUG

Two grams of the EPA form of omega-3 daily and 50 mgs of sertraline daily for 10 weeks

Placebo

Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.

Interventions

Omega-3 supplement

Two grams of the EPA form of omega-3 daily and 50 mgs of sertraline daily for 10 weeks

Intervention Type: DRUG

Placebo

Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.

Intervention Type: DRUG

Other Intervention Names

EPA Plus Minami Nutrition

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert M Carney, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University Medical Center

St Louis, Missouri, United States

Countries

United States

References

Carney RM, Freedland KE, Rubin EH, Rich MW, Steinmeyer BC, Harris WS. A Randomized Placebo-Controlled Trial of Omega-3 and Sertraline in Depressed Patients With or at Risk for Coronary Heart Disease. J Clin Psychiatry. 2019 Jun 4;80(4):19m12742. doi: 10.4088/JCP.19m12742.

Reference Type: DERIVED

PMID: 31163106 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

R01HL117805

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201309002

Identifier Type: -

Identifier Source: org_study_id