Omega-3 augmentation of sertraline in treatment of depression in patients with coronary heart disease: a randomized controlled trial.
BACKGROUND
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).


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


METHODS
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.


METHODS
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; t(112) = 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; t(116) = -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; t(115) = 0.12; P = .90). The groups did not differ on predefined indicators of depression remission (BDI-II < or = 8: placebo, 27.4% vs omega-3, 28.3%; odds ratio [OR], 0.96; 95% CI, 0.43-2.15; t(113) = -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; t(112) = 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.


BACKGROUND
clinicaltrials.gov Identifier: NCT00116857.
Carney
Robert M
RM
Behavioral Medicine Center, Department of Psychiatry, Washington University School of Medicine, 4320 Forest Park Ave, Ste 301, St Louis, MO 63108, USA. carneyr@bmc.wustl.edu
Freedland
Kenneth E
KE
Rubin
Eugene H
EH
Rich
Michael W
MW
Steinmeyer
Brian C
BC
Harris
William S
WS
D000928:Antidepressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D015897:Comorbidity; D003327:Coronary Disease / Q000453:epidemiology* / Q000523:psychology; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000453:epidemiology*; D019587:Dietary Supplements; D004281:Docosahexaenoic Acids / Q000008:administration & dosage / Q000627:therapeutic use; D004311:Double-Blind Method; D004357:Drug Synergism; D015118:Eicosapentaenoic Acid / Q000008:administration & dosage / Q000627:therapeutic use; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020280:Sertraline / Q000008:administration & dosage / Q000627:therapeutic use*
D000928:Antidepressive Agents; D015525:Fatty Acids, Omega-3; D004281:Docosahexaenoic Acids; D015118:Eicosapentaenoic Acid; D020280:Sertraline