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

Completed · Phase 2 · Has a placebo group

Conditions studied: Depression

In brief

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).

Key facts

Study ID

NCT02021669

Run by

Washington University School of Medicine

People needed

144

Starts

2014-05-14

Expected to finish

2018-09-13

Last updated by the study team

2019-09-04

Who can join

Age: 25 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Washington University Medical Center — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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