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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Carney, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00116857
First received: June 30, 2005
Last updated: September 11, 2012
Last verified: September 2012

June 30, 2005
September 11, 2012
February 2005
June 2009   (final data collection date for primary outcome measure)
Beck Depression Inventory-II [ Time Frame: Measured at Baseline and 10 weeks ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00116857 on ClinicalTrials.gov Archive Site
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Omega-3 Fatty Acids to Improve Depression and Reduce Cardiovascular Risk Factors
Omega-3 for Depression and Other Cardiac Risk Factors

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

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 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.

DESIGN NARRATIVE:

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Cardiovascular Diseases
  • Depression
  • Heart Diseases
  • Myocardial Infarction
  • Angina, Unstable
  • Drug: Sertraline/omega-3
    Sertraline (50 mgs) plus omega-3 (2 grams)
  • Drug: Sertraline/Corn Oil
    Sertraline (50 mgs) plus corn oil (2 grams) (placebo)
  • Active Comparator: Sertraline/omega-3 supplement
    Intervention: Drug: Sertraline/omega-3
  • Placebo Comparator: Sertraline/corn oil
    Intervention: Drug: Sertraline/Corn Oil

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
November 2009
June 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00116857
186, R01HL076808
Yes
Robert Carney, Washington University School of Medicine
Washington University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Study Chair: Robert M. Carney, PhD Washington University School of Medicine
Washington University School of Medicine
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP