Status:
COMPLETED
Omega-3 Fatty Acids to Improve Depression and Reduce Cardiovascular Risk Factors
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Diseases
Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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).
Detailed Description
BACKGROUND: Depression is a risk factor for morbidity and mortality following an acute MI and unstable angina. Two recent studies (sertraline versus placebo and sertraline plus cognitive therapy vers...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00116857
Start Date
February 1 2005
End Date
November 1 2009
Last Update
September 12 2012
Active Locations (1)
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1
Washington University
St Louis, Missouri, United States, 63108