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

• Status: Completed
• Trial end date: 2018-09-13
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Sertraline

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