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A Randomized Controlled Trial

Robert M. Carney, PhD; Kenneth E. Freedland, PhD; Eugene H. Rubin, MD, PhD; Michael W. Rich, MD; Brian C. Steinmeyer, MS; William S. Harris, PhD

JAMA. 2009;302(15):1651-1657.

Context  Studies of depressed psychiatric patients have shown that antidepressant efficacy can be increased by augmentation with omega-3 fatty acids.

Objective  To determine whether omega-3 improves the response to sertraline in patients with major depression and coronary heart disease (CHD).

Design, Setting, and Participants  Randomized controlled trial. Between May 2005 and December 2008, 122 patients in St Louis, Missouri, with major depression and CHD were randomized.

Interventions  After a 2-week run-in period, all patients were given 50 mg/d of sertraline and randomized in double-blind fashion to receive 2 g/d of omega-3 acid ethyl esters (930 mg of eicosapentaenoic acid [EPA] and 750 mg of docosahexaenoic acid [DHA]) (n=62) or to corn oil placebo capsules (n=60) for 10 weeks.

Main Outcome Measures  Scores on the Beck Depression Inventory (BDI-II) and the Hamilton Rating Scale for Depression (HAM-D).

Results  Adherence to the medication regimen was 97% or more in both groups for both medications. There were no differences in weekly BDI-II scores (treatment x time interaction = 0.02; 95% confidence interval [CI], –0.33 to 0.36; t₁₁₂ = 0.11; P = .91), pre-post BDI-II scores (placebo, 14.8 vs omega-3, 16.1; 95% difference-in-means CI, –4.5 to 2.0; t₁₁₆ = –0.77; P = .44), or HAM-D scores (placebo, 9.4 vs omega-3, 9.3; 95% difference-in-means CI, –2.2 to 2.4; t₁₁₅ = 0.12; P = .90). The groups did not differ on predefined indicators of depression remission (BDI-II 8: placebo, 27.4% vs omega-3, 28.3%; odds ratio [OR], 0.96; 95% CI, 0.43-2.15; t₁₁₃ = –0.11; P = .91) or response (>50% reduction in BDI-II from baseline: placebo, 49.0% vs omega-3, 47.7%; OR, 1.06; 95% CI, 0.51-2.19; t₁₁₂ = 0.15; P = .88).

Conclusions  Treatment of patients with CHD and major depression with sertraline and omega-3 fatty acids did not result in superior depression outcomes at 10 weeks, compared with sertraline and placebo. Whether higher doses of omega-3 or sertraline, a different ratio of EPA to DHA, longer treatment, or omega-3 monotherapy can improve depression in patients with CHD remains to be determined.

Trial Registration  clinicaltrials.gov Identifier: NCT00116857

Author Affiliations: Departments of Psychiatry (Drs Carney, Freedland, and Rubin and Mr Steinmeyer) and Medicine (Dr Rich), Washington University School of Medicine, St Louis, Missouri; and Cardiovascular Health Research Center, Sanford Research, University of South Dakota, Sioux Falls (Dr Harris).

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