Omega-3 for Depression and Other Cardiac Risk Factors - 2 (Omega-3(2))

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Washington University School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Carney, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02021669
First received: December 19, 2013
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

The purpose of this 10 week randomized, placebo-controlled, double-blind clinical trial is to determine whether antidepressant augmentation with two grams of EPA omega-3 per day is superior to antidepressant therapy alone for major depression in patients with coronary heart disease (CHD).


Condition Intervention Phase
Depression
Drug: Omega-3 supplement
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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-2

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Beck Depression Inventory - 2 (BDI-2) [ Time Frame: Change from baseline to 10 weeks (post-treatment) ] [ Designated as safety issue: No ]
    The BDI-2 is a 21-item self-report inventory of depression symptoms.


Secondary Outcome Measures:
  • Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: Change from baseline to 10 weeks (post-treatment) ] [ Designated as safety issue: No ]
    The HAMD-17 is a 17-item, observer-rated measure of depression symptoms.

  • Heart Rate Variability (HRV) [ Time Frame: Change from baseline to 10 weeks (post-treatment) ] [ Designated as safety issue: No ]
    Very low frequency (VLF) power and other indices of HRV are indicators of cardiovascular autonomic function.

  • Interleukin-6 (IL-6) [ Time Frame: Change from baseline to 10 weeks (post-treatment) ] [ Designated as safety issue: No ]
    IL-6 is a pro-inflammatory cytokine.


Estimated Enrollment: 150
Study Start Date: April 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omega-3 supplement
Two grams of the EPA form of omega-3 plus 50 mg of sertraline daily for 10 weeks
Drug: Omega-3 supplement
Two grams of the EPA form of omega-3 daily and 50 mgs of sertraline daily for 10 weeks
Other Name: EPA Plus Minami Nutrition
Placebo Comparator: Placebo
Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.

Detailed Description:

Depression increases the risk for cardiac morbidity and mortality 2-4 fold in patients with coronary heart disease (CHD). Recent clinical trials have tested standard treatments for comorbid depression in patients with CHD, and some have evaluated their effects on cardiac morbidity and mortality. Most of these trials have shown that standard treatments have only modest effects on depression and have produced relatively small differences between the intervention and control condition. Consequently, they have been unable to determine whether effective treatment of depression can improve cardiac outcomes. Low dietary intake and low plasma phospholipid or erythrocyte levels of two omega-3 fatty acids(FAs), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are associated with depression and other cardiac risk markers. There is growing evidence from small psychiatric trials that the efficacy of standard antidepressants can be improved by coadministration of an omega-3 FA formulation containing at least 1 gram of EPA. The purpose of the proposed research is to determine whether antidepressant augmentation with this omega-3 formulation is superior to antidepressant therapy alone for major depression in patients with CHD. The proposed study is a randomized, placebo-controlled, double-blind clinical trial. Consenting patients with established coronary heart disease who meet the Diagnostic Statistical Manual (DSM)-5 criteria for a major depressive episode will undergo a baseline evaluation and then be randomly assigned to receive either 50 mg/day of sertraline plus omega-3 FA or 50 mg/day of sertraline plus placebo for 10 weeks. At baseline and after 10 weeks, participants will complete assessments of depression, 24 hour ambulatory ECG monitoring to measure 24 hour heart rate and heart rate variability, and blood draws to measure procoagulant and proinflammatory markers and blood levels of EPA, DHA, other omega-3 FAs, and the omega-6 FAs. If sertraline plus this omega-3 formulation significantly reduces depression compared to sertraline plus placebo, and if it improves or at least does not worsen other cardiovascular risk markers, this study will provide a strong basis for proposing a multicenter clinical trial of sertraline augmented with omega-3 to determine whether treatment of depression can improve survival in patients with CHD and depression.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented coronary heart disease
  • Diagnosis of major depression based on structured interview

Exclusion Criteria:

  • Moderate to severe cognitive impairment
  • Meets DSM-5 criteria for depressive disorder due to a general medical condition or medication
  • Major Axis I psychiatric disorder other than unipolar depression or an anxiety disorder, a high risk of suicide, or current substance abuse other than tobacco;
  • Not expected to survive one year or physically unable to tolerate the study protocol
  • Known sensitivity to sertraline or omega-3, or an allergy to fish oil or shellfish
  • Taking an antidepressant or an omega-3 supplement at baseline
  • Exempted by their cardiologist or primary care physician
  • Refuses to provide informed consent
  • Participating in a competing protocol or trial
  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: NCT02021669

Contacts
Contact: Patricia Herzing, RN 314-286-1360 herzingp@bmc.wustl.edu
Contact: Kim Metze, BA 314-286-1300 metzek@bmc.wustl.edu

Locations
United States, Missouri
Washington University Medical Center Recruiting
St Louis, Missouri, United States, 63108
Contact: Robert M Carney, PhD    314-286-1313    carneyr@bmc.wustl.edu   
Contact: Patricia Herzing, RN    314-286-1360    herzingp@bmc.wustl.edu   
Principal Investigator: Robert M Carney, PhD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Robert M Carney, PhD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Robert Carney, Professor of Psychiatry, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02021669     History of Changes
Other Study ID Numbers: 201309002, R01HL117805
Study First Received: December 19, 2013
Last Updated: April 1, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Antidepressive agents
Coronary disease
Depression
Depressive disorder
Fatty Acids, Omega-3

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014