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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00116857
Recruitment Status : Completed
First Posted : July 1, 2005
Results First Posted : September 12, 2012
Last Update Posted : September 12, 2012
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert Carney, Washington University School of Medicine

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).

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Depression Heart Diseases Myocardial Infarction Angina, Unstable Drug: Sertraline/omega-3 Drug: Sertraline/Corn Oil Phase 3

Detailed Description:


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 versus usual care) reported only modest reductions in depression following an acute MI or unstable angina, and many treated patients remained depressed. Neither study reported better medical outcomes in the treated patients. Earlier studies found that even subclinical depression increases the risk of mortality in cardiac patients. Thus, more effective treatments are needed to eliminate depression and improve medical outcomes in patients following an acute MI or unstable angina. Omega-3 FAs have been shown to augment the efficacy of antidepressants for major depression and to improve several cardiac risk factors. However, these findings have been shown in separate lines of research. No previous study has investigated whether omega-3 FAs can simultaneously improve depression and reduce cardiovascular risk factors in post-MI patients.


One hundred fifty patients who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for a current major depressive episode and who score 15 or higher on the Beck Depression Inventory II with a history of acute MI, unstable angina, or other cardiac event will be enrolled in a randomized, double-blind, placebo-controlled trial of omega-3 augmentation of sertraline. The participants will be randomly assigned to receive either sertraline plus omega-3 or sertraline plus placebo for 10 weeks. At baseline and again after ten weeks, the subjects will complete the following: 1) assessments of depression and psychosocial functioning; 2) 24-hour electrocardiogram monitoring for heart rate variability analysis; and 3) blood draws to measure procoagulant and proinflammatory markers, and plasma levels of sertraline and omega-3. If this study shows that omega-3 reduces depression and improves cardiovascular disease markers, there will be a basis for proposing a larger clinical trial to determine whether it can also improve survival after hospitalization for acute MI or unstable angina.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Omega-3 for Depression and Other Cardiac Risk Factors
Study Start Date : February 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Sertraline/omega-3 supplement Drug: Sertraline/omega-3
Sertraline (50 mgs) plus omega-3 (2 grams)

Placebo Comparator: Sertraline/corn oil Drug: Sertraline/Corn Oil
Sertraline (50 mgs) plus corn oil (2 grams) (placebo)

Primary Outcome Measures :
  1. Beck Depression Inventory-II [ Time Frame: Measured at Baseline and 10 weeks ]
    Beck Depression Inventory-II scores on a scale of 0 to 63, minimum score equals 0 maximum score equals 63. Higher value represents a worse outcome. Baseline scores are compared to scores after treatment.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00116857

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United States, Missouri
Washington University
St. Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
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Study Chair: Robert M. Carney, PhD Washington University School of Medicine
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Robert Carney, Professor, Washington University School of Medicine Identifier: NCT00116857    
Other Study ID Numbers: 186
R01HL076808 ( U.S. NIH Grant/Contract )
First Posted: July 1, 2005    Key Record Dates
Results First Posted: September 12, 2012
Last Update Posted: September 12, 2012
Last Verified: September 2012
Additional relevant MeSH terms:
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Cardiovascular Diseases
Myocardial Infarction
Heart Diseases
Angina, Unstable
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Angina Pectoris
Chest Pain
Neurologic Manifestations
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs