Omega-3 Fatty Acids to Improve Depression and Reduce Cardiovascular Risk Factors

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine the effects of omega-3 fatty acid (FA) augmentation of sertraline on depression and cardiac endpoints after myocardial infarction (MI).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Sertraline

Criteria

Inclusion Criteria:

• Meets the DSM-IV criteria for a current major depressive episode

• Score of 15 or higher on the Beck Depression Inventory II

• History of acute myocardial infarction, unstable angina, or documented coronary disease

Exclusion Criteria:

• Physician or patient refusal

• Lives far away from study site

• Current alcohol or drug abuse

• Psychosis, dementia, or bipolar disorder

• Already taking Omega-3

• Medically ill or disabled such that patient is unable to participate

• Comorbid illness likely to be fatal within 1 year of study entry

• Seizure disorder or takes anticonvulsants

• Pregnant or breast feeding

• Liver or kidney disease

• Severe hypertriglyceridemia (greater than 400 mg/dL)

• Bleeding or clotting disorder

• Type 2 diabetes with a hemoglobin A1c (HbA1c) level greater than 10

• Taking lithium or monoamine oxidase inhibitor (MAO-I)