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

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ClinicalTrials.gov Identifier: NCT00116857
Recruitment Status : Completed
First Posted : July 1, 2005
Results First Posted : September 12, 2012
Last Update Posted : September 12, 2012
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert Carney, Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE June 30, 2005
First Posted Date  ICMJE July 1, 2005
Results First Submitted Date  ICMJE July 3, 2012
Results First Posted Date  ICMJE September 12, 2012
Last Update Posted Date September 12, 2012
Study Start Date  ICMJE February 2005
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2012)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00116857 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omega-3 Fatty Acids to Improve Depression and Reduce Cardiovascular Risk Factors
Official Title  ICMJE Omega-3 for Depression and Other Cardiac Risk Factors
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiovascular Diseases
  • Depression
  • Heart Diseases
  • Myocardial Infarction
  • Angina, Unstable
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Active Comparator: Sertraline/omega-3 supplement
    Intervention: Drug: Sertraline/omega-3
  • Placebo Comparator: Sertraline/corn oil
    Intervention: Drug: Sertraline/Corn Oil
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2010)
122
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00116857
Other Study ID Numbers  ICMJE 186
R01HL076808 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert Carney, Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Study Chair: Robert M. Carney, PhD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date September 2012

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