Effect of Long-term Supplementation With Marine Omega-3 Fatty Acids vs Placebo on Risk of Depression or Clinically Relevant Depressive Symptoms and on Change in Mood Scores: A Randomized Clinical Trial
Okereke OI, Vyas CM, Mischoulon D, Chang G, Cook NR, Weinberg A, Bubes V, Copeland T, Friedenberg G, Lee IM, Buring JE, Reynolds CF, Manson JE
JAMA · 85 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Institute on Aging
- Gobierno
- National Heart, Lung, and Blood Institute
- Gobierno
- National Institute of Mental Health
- Gobierno
- National Cancer Institute
- Gobierno
- National Institute of Diabetes and Digestive and Kidney Diseases
- Gobierno
- National Institute of Arthritis and Musculoskeletal and Skin Diseases
- Gobierno
- National Center for Complementary and Integrative Health
- Gobierno
- NCI NIH HHS
- Gobierno
- NIAMS NIH HHS
- Gobierno
- NIDDK NIH HHS
- Gobierno
- NIMH NIH HHS
- Gobierno
- NIA NIH HHS
- Gobierno
- NCCIH NIH HHS
- Gobierno
- NHLBI NIH HHS
- Subvenciones
- National Institute on Aging (R01AG036755); National Cancer Institute (U01CA138962); National Institute of Mental Health (R01MH091448); National Institute of Diabetes and Digestive and Kidney Diseases (R01DK088762); National Institute of Mental Health (P30MH090333); National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01 AR060574); National Institute of Diabetes and Digestive and Kidney Diseases (R01DK088078); National Heart, Lung, and Blood Institute (R01 HL101932); National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01AR059086); National Heart, Lung, and Blood Institute (R01HL102122); National Cancer Institute (R01CA138962); National Center for Complementary and Integrative Health (R01AT011729)
Según 14 financiadores declarados.
Publicación
- Publicado
- 2021-12-21 · JAMA · vol. 326 · número 23 · pág. 2385
- Editorial
- American Medical Association
- Citado
- 120 citas · más que el 99% de estudios similares · 8.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 33 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
- marine omega-3 fatty acids, fish oil supplementation, depression prevention, depressive symptoms, mood, vitamin D3, eicosapentaenoic acid, docosahexaenoic acid, geriatric depression, PHQ-8, antidepressant effects, depression recurrence, older adults, cardiovascular disease prevention, cancer prevention
- MeSH
- humans, fatty acids, omega-3, treatment failure, proportional hazards models, double-blind method, depression, affect, depressive disorder, dietary supplements, aged, middle aged, female, male
13 autores
- Olivia I. Okereke🇺🇸 · autor de correspondenciaBrigham and Women's Hospital; Harvard University; Massachusetts General Hospital
- Chirag M. Vyas🇺🇸Harvard University; Massachusetts General Hospital
- David Mischoulon🇺🇸Harvard University; Massachusetts General Hospital
- Grace Chang🇺🇸VA Boston Healthcare System
- Nancy R. Cook🇺🇸Brigham and Women's Hospital; Harvard University
- Alison Weinberg🇺🇸Brigham and Women's Hospital; Harvard University
- Vadim Y. Bubes🇺🇸Brigham and Women's Hospital; Harvard University
- Trisha Copeland🇺🇸Brigham and Women's Hospital; Harvard University
- Georgina Friedenberg🇺🇸Brigham and Women's Hospital; Harvard University
- I‐Min Lee🇺🇸Brigham and Women's Hospital; Harvard University
- Julie E. Buring🇺🇸Brigham and Women's Hospital; Harvard University
- Charles F. Reynolds🇺🇸University of Pittsburgh; UPMC Health System; University of Pittsburgh Medical Center
- JoAnn E. Manson🇺🇸Brigham and Women's Hospital; Harvard University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Importance
Marine omega-3 fatty acid (omega-3) supplements have been used to treat depression but their ability to prevent depression in the general adult population is unknown.
Objective
To test effects of omega-3 supplementation on late-life depression risk and mood scores.
Design, setting, and participants
A total of 18 353 adults participated in the VITAL-DEP (Vitamin D and Omega-3 Trial-Depression Endpoint Prevention) ancillary study to VITAL, a randomized trial of cardiovascular disease and cancer prevention among 25 871 US adults. There were 16 657 at risk of incident depression (no previous depression) and 1696 at risk of recurrent depression (previous depression, but not for the past 2 years). Randomization occurred from November 2011 through March 2014; randomized treatment ended on December 31, 2017.
Interventions
Randomized 2 × 2 factorial assignment to vitamin D3 (2000 IU/d), marine omega-3 fatty acids (1 g/d of fish oil, including 465 mg of eicosapentaenoic acid and 375 mg of docosahexaenoic acid) or placebo; 9171 were randomized to omega-3 and 9182 were randomized to matching placebo.
Main outcomes and measures
Prespecified coprimary outcomes were risk of depression or clinically relevant depressive symptoms (total of incident + recurrent cases); mean difference in mood score (8-item Patient Health Questionnaire [PHQ-8] depression scale).
Results
Among 18 353 participants who were randomized (mean age, 67.5 [SD, 7.1] years; 49.2% women), 90.3% completed the trial (93.5% among those alive at the end of the trial); the median treatment duration was 5.3 years. The test for interaction between the omega-3 and the vitamin D agents was not significant (P for interaction = .14). Depression risk was significantly higher comparing omega-3 (651 events, 13.9 per 1000 person-years) with placebo (583 events, 12.3 per 1000 person-years; hazard ratio [HR], 1.13; 95% CI, 1.01-1.26; P = .03). No significant differences were observed comparing omega-3 with placebo groups in longitudinal mood scores: the mean difference in change in PHQ-8 score was 0.03 points (95% CI, -0.01 to 0.07; P = .19). Regarding serious and common adverse events, the respective prevalence values in omega-3 vs placebo groups were major cardiovascular events (2.7% vs 2.9%), all-cause mortality (3.3% vs 3.1%), suicide (0.02% vs 0.01%), gastrointestinal bleeding (2.6% vs 2.7%), easy bruising (24.8% vs 25.1%), and stomach upset or pain (35.2% vs 35.1%).
Conclusions and relevance
Among adults aged 50 years or older without clinically relevant depressive symptoms at baseline, treatment with omega-3 supplements compared with placebo yielded mixed results, with a small but statistically significant increase in risk of depression or clinically relevant depressive symptoms but no difference in mood scores, over a median follow-up of 5.3 years. These findings do not support the use of omega-3 supplements in adults to prevent depression.
Trial registration
ClinicalTrials.gov Identifiers: NCT01696435 and NCT01169259.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
Confianza de la comunidad
Cargando…
¿Cuánto confías en los hallazgos de este estudio?
Comentarios
¿Algo está mal aquí?
Señala este estudio si su información, etiquetas o financiación parecen incorrectas. Un editor revisa cada señalamiento.
Información educativa sobre investigación publicada. No es consejo médico ni una recomendación para empezar o dejar nada.