6/30/23, 12:37 AM VITAL-DEP Pathway Feedback Search Clinical Topics Home Studies VITAL DEP VITAL DEP Disease Major depressive disorder Trial question What is the effect of long-term supplementation of marine omega-3 fatty acids in older adults without clinically relevant depressive symptoms? Study design Multi-center Double blinded RCT Population Characteristics of study participants 49.0% female N = 18353 51.0% male 18353 patients (9023 female, 9330 male) Inclusion criteria: adults aged 50 years at risk of incident depression or at risk of recurrent depression Key exclusion criteria: significant depressive symptoms, history of alcohol or substance disorder, use of psychotropics, hypothyroidism, major neurologic disorder or delirium episode in < 12 months Interventions N=9171 omega-3 (1 g/d of fish oil, including 465 mg of eicosapentaenoic acid and 375 mg of docosahexaenoic acid) N=9182 placebo (matching omega-3 placebo) Primary outcome Incidence of of depression or clinically relevant depressive symptoms https://web.pathway.md/studies/rec6bCPPlV6OQxhXe 1/2 6/30/23, 12:37 AM VITAL-DEP Pathway 13.9/1K py 13.9 12.3 10.4/1K py 7.0/1K py 3.5/1K py Significant increase 0.0/1K py Omega-3 Placebo Significant increase in the incidence of of depression or clinically relevant depressive symptoms (13.9 events /1000 py vs. 12.3 events /1000 py; HR 1.13, 95% CI 1.01 to 1.26) Safety outcomes No significant differences in suicide, gastrointestinal bleeding, easy bruising, stomach upset or pain. Conclusion In adults aged 50 years at risk of incident depression or at risk of recurrent depression, omega- 3 was inferior to placebo with respect to the incidence of of depression or clinically relevant depressive symptoms. Reference Olivia I Okereke, Chirag M Vyas, David Mischoulon et al. 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. JAMA. 2021 Dec 21;326(23):2385-2394. Open reference URL https://web.pathway.md/studies/rec6bCPPlV6OQxhXe 2/2