Omega-3 augmentation of sertraline in treatment of depression in patients with coronary heart disease: A randomized controlled trial

Robert M. Carney, Kenneth E. Freedland, Eugene H. Rubin, Michael W. Rich, Brian C. Steinmeyer, William Harris

Research output: Contribution to journalArticle

88 Citations (Scopus)

Abstract

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), prepost 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.

Original languageEnglish (US)
Pages (from-to)1651-1657
Number of pages7
JournalJAMA - Journal of the American Medical Association
Volume302
Issue number15
DOIs
StatePublished - 2009
Externally publishedYes

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Sertraline
Coronary Disease
Randomized Controlled Trials
Depression
Placebos
Confidence Intervals
Eicosapentaenoic Acid
Docosahexaenoic Acids
Omega-3 Fatty Acids
Therapeutics
Odds Ratio
Corn Oil
Medication Adherence
Antidepressive Agents
Capsules
Psychiatry
Esters
Outcome Assessment (Health Care)
Equipment and Supplies
Acids

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Omega-3 augmentation of sertraline in treatment of depression in patients with coronary heart disease : A randomized controlled trial. / Carney, Robert M.; Freedland, Kenneth E.; Rubin, Eugene H.; Rich, Michael W.; Steinmeyer, Brian C.; Harris, William.

In: JAMA - Journal of the American Medical Association, Vol. 302, No. 15, 2009, p. 1651-1657.

Research output: Contribution to journalArticle

Carney, Robert M. ; Freedland, Kenneth E. ; Rubin, Eugene H. ; Rich, Michael W. ; Steinmeyer, Brian C. ; Harris, William. / Omega-3 augmentation of sertraline in treatment of depression in patients with coronary heart disease : A randomized controlled trial. In: JAMA - Journal of the American Medical Association. 2009 ; Vol. 302, No. 15. pp. 1651-1657.
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title = "Omega-3 augmentation of sertraline in treatment of depression in patients with coronary heart disease: A randomized controlled trial",
abstract = "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), prepost 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 = "Carney, {Robert M.} and Freedland, {Kenneth E.} and Rubin, {Eugene H.} and Rich, {Michael W.} and Steinmeyer, {Brian C.} and William Harris",
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T1 - Omega-3 augmentation of sertraline in treatment of depression in patients with coronary heart disease

T2 - A randomized controlled trial

AU - Carney, Robert M.

AU - Freedland, Kenneth E.

AU - Rubin, Eugene H.

AU - Rich, Michael W.

AU - Steinmeyer, Brian C.

AU - Harris, William

PY - 2009

Y1 - 2009

N2 - 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), prepost 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.

AB - 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), prepost 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.

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