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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Omega-3 for Depression and Other Cardiac Risk Factors

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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.


Enrollment: 122
Study Start Date: February 2005
Study Completion Date: November 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116857

Locations
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Study Chair: Robert M. Carney, PhD Washington University School of Medicine
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Carney, Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00116857     History of Changes
Other Study ID Numbers: 186, R01HL076808
Study First Received: June 30, 2005
Results First Received: July 3, 2012
Last Updated: September 11, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Angina, Unstable
Cardiovascular Diseases
Depression
Depressive Disorder
Heart Diseases
Infarction
Myocardial Infarction
Angina Pectoris
Behavioral Symptoms
Chest Pain
Ischemia
Mental Disorders
Mood Disorders
Myocardial Ischemia
Necrosis
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Sertraline
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors

ClinicalTrials.gov processed this record on October 20, 2014