Phase 2
Completed N=144
Omega-3 for Depression and Other Cardiac Risk Factors - 2
Source: ClinicalTrials.gov NCT02021669 ↗Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Beck Depression Inventory-II (BDI-II) — 29.9; 29.1; 11.0; 9.1 score on a scale
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Beck Depression Inventory-II (BDI-II) |
29.9; 29.1; 11.0; 9.1 | — |
| SECONDARY Hamilton Depression Rating Scale (HAM-D, 17) |
17.4; 17.0; 7.1; 6.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT02021669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.