CompletedPhase 2

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

United States144 participantsStarted 2014-05-14

Plain-language 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).

Who can participate

Age range25 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Beck Depression Inventory-II (BDI-II)

Timeframe: Change from baseline to 10 weeks (post-treatment)

Trial details

NCT IDNCT02021669

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09-13

Results submitted2019-07-12

View on ClinicalTrials.gov More Depression trials