drugset / Trial / NCT02021669
Omega-3 for Depression and Other Cardiac Risk Factors - 2
Phase 2
Completed
144 enrolled
Washington University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupQuadruple-blindTreatment
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).
Timeline
- Start
- 2014-05-14
- Primary completion
- 2018-09-13
- Completion
- 2018-09-13
Outcome
Missed primary endpoint
paper After 10 weeks of treatment, there were no differences between the arms on the mean baseline-adjusted BDI-II (placebo, 10.3; EPA, 12.1; P = .22) PMID 31163106 ↗
paper Augmentation of sertraline with 2 g/d of EPA for 10 weeks did not result in greater improvement in depressive symptoms compared to sertraline and corn oil placebo PMID 31163106 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eicosapentaenoic acid | Small molecule | 2 g | — |
| Background | Sertraline | Small molecule | 50 mg | — |