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Ensayo controlado aleatorizado2009

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

Carney RM, Freedland KE, Rubin EH, Rich MW, Steinmeyer BC, Harris WS

JAMA · 93 citas

Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Marcadores de salud y funcionamiento

Quién lo pagó

Financiación
Financiación independiente
Gobierno
National Heart, Lung, and Blood Institute
Gobierno
NHLBI NIH HHS
Subvenciones
National Heart, Lung, and Blood Institute (R01 HL076808); National Heart, Lung, and Blood Institute (R01 HL076808-01A1)

Según 2 financiadores declarados.

Publicación

Publicado
2009-10-20 · JAMA · vol. 302 · número 15 · pág. 1651
Editorial
American Medical Association
Citado
141 citas · más que el 99% de estudios similares · 13.1× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
42 trabajos
Acceso
Acceso abierto (copia en repositorio)
Áreas de investigación
Fatty Acid Research and Health · Treatment of Major Depression · Tryptophan and brain disorders
Palabras clave
omega-3 fatty acids, sertraline, depression, coronary artery disease, antidepressant augmentation, eicosapentaenoic acid, docosahexaenoic acid, omega-3 acid ethyl esters, major depressive disorder, depression remission, medication adherence, antidepressant efficacy
MeSH
humans, coronary disease, sertraline, fatty acids, omega-3, docosahexaenoic acids, eicosapentaenoic acid, antidepressive agents, double-blind method, comorbidity, drug synergism, dietary supplements, middle aged, female, male, major depressive disorder

6 autores

  • Robert M. Carney🇺🇸Washington University in St. Louis
  • Kenneth E. Freedland🇺🇸Washington University in St. Louis
  • Eugene H. Rubin🇺🇸Washington University in St. Louis
  • Michael W. Rich🇺🇸Washington University in St. Louis
  • Brian C. Steinmeyer🇺🇸Washington University in St. Louis
  • William Stephen Harris

Resumen

El texto original del estudio, en el idioma en que se publicó.

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; 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 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.

Trial registration

clinicaltrials.gov Identifier: NCT00116857.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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