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Omega 3 for Treatment of Depression in Patients With Heart Failure (OCEAN)

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.
 
ClinicalTrials.gov Identifier: NCT02057406
Recruitment Status : Completed
First Posted : February 7, 2014
Results First Posted : June 12, 2017
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Wei Jiang, Duke University

Study Description
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Brief Summary:
Omega 3 supplements will improve depressive symptoms to a greater extent than placebo in heart failure patients with moderate to severe major depressive disorder.

Condition or disease Intervention/treatment Phase
Depression Drug: 2:1 EPA/DHA Drug: High EPA Other: Placebo Phase 3

Detailed Description:

The primary objective of this study is to determine whether (Hypothesis 1a) and how (Hypothesis 1b) the two omega 3 supplements will reduce depressive symptoms in heart failure (HF) patients with moderate-to-severe major depressive disorder (MDD).

Hypothesis 1a: Omega 3 supplements will improve depressive symptoms to a greater extent than placebo; Hypothesis 1b: Pure eicosapentaenoic acid (EPA) will be superior to the EPA: docosahexaenoic acid (DHA) 2:1 in depression improvement.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Omega 3 for Comorbid Depression and Heart Failure Treatment
Actual Study Start Date : May 2014
Actual Primary Completion Date : May 19, 2016
Actual Study Completion Date : December 2, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 2:1 EPA/DHA
400/200 EPA/DHA fish oil 2 grams
 Drug: 2:1 EPA/DHA
400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams
Other Name: 400 EPA/200 DHA 2 grams
Active Comparator: High EPA
Almost pure EPA 2 grams
 Drug: High EPA
Other Name: An almost pure Eicosapentaenoic acid 2 grams
Placebo Comparator: Placebo
Matched placebo corn oil capsules
 Other: Placebo
Other Name: Matched placebo corn oil capsules


Outcome Measures
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Primary Outcome Measures :
  1. Endpoint Hamilton Depression Rating Scale (HAMD) Scores Adjusted for Age, Sex, Treatment Site, and Baseline HAMD Scores. [ Time Frame: Week 12 ]
    Endpoint HAMD scores are mean values adjusted for age, race, sex, treatment site, and the baseline HAMD value. The range for the HAMD scores is 0 to 52 with higher scores indicating a greater severity of depressive symptoms.

  2. Endpoint Red Blood Cell/Plasma EPA Values Adjusted for Age, Sex, Treatment Site, and Baseline Red Blood Cell/Plasma EPA Values. [ Time Frame: Week 12 ]
    Endpoint EPA values are mean values adjusted for age, race, sex, treatment site, and the baseline EPA value. Red blood cell/plasma EPA values are expressed as a percent of total identified fatty acids.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male and female patients, age greater than or equal to 21 years
  • Diagnosis of Major Depressive Disorder determined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria with a Hamilton Depression Rating Scale Score greater than or equal to 18*

  • New York Heart Association Class greater than or equal to II

    • For patients with with left ventricular ejection fraction greater than 40 %, abnormal brain natriuretic peptide and/or previous hospitalization due to heart failure is also required
    • For inpatients, the Hamilton Depression Rating Scale scores need to be remain at 18 or above for two weeks following the discharge

Exclusion Criteria:

  • Significant cognitive impairment, indicated as a Mini-Mental State Examination (MMSE) total score of 23 or lower
  • History of alcohol or other drug dependence within the past 90 days
  • Severe physical disability (visual, sensory, or motor) that may interfere with psychiatric assessment
  • History or presence of psychoses, bipolar disorder, and/or severe personality disorders
  • Life-threatening comorbidity with the likelihood of 50% mortality in one year
  • Active suicidal ideations
  • Current use of antipsychotic medications or psychotropic medications except Selective Serotonin Reuptake Inhibitors (SSRIs) and /or benzodiazepine
  • Female patients who have a positive pregnancy test or are lactating. If female patients are of childbearing potential, they must use an effective and accepted means of contraception, such as oral contraceptives or a double-barrier method (condom and diaphragm) to protect against pregnancy
  • Documented history of hypersensitivity or intolerance to omega 3 products; or use of omega 3 supplement for greater than or equal to 3 months at an equivalent or greater dose of the proposed study
  • Treatment with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within 90 days*
  • Uncorrected hypothyroidism or hyperthyroidism
  • Treatment with any investigational agent within 1 month before randomization

  • Acute coronary syndrome, i.e., Myocardial Infarction (MI) or unstable angina, revascularization procedure within the preceding month, or planned cardiac surgery within 3 months postrandomization

    • The exclusion of patients who received ECT or TMS within 90 days is adopted from other depression-intervention trials and meant to eliminate confounders. It is believed that the effects of ECT on mood and cognition may last for a couple of months, and duration of TMS effects is poorly known and may be similar to the ECT intervention.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02057406


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wei Jiang
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Wei Jiang, MD Duke University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wei Jiang, Professor, Duke University
ClinicalTrials.gov Identifier: NCT02057406    
Other Study ID Numbers: Pro00043654
R34MH097034-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 7, 2014    Key Record Dates
Results First Posted: June 12, 2017
Last Update Posted: May 14, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Heart Failure
Depression
Depressive Disorder
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Heart Diseases
Cardiovascular Diseases