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

April 12, 2018 updated by: Wei Jiang

Omega 3 for Comorbid Depression and Heart Failure Treatment

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 400 EPA/200 DHA 2 grams
Active Comparator: High EPA
Almost pure EPA 2 grams
Drug: High EPA
Other Names:
  • An almost pure Eicosapentaenoic acid 2 grams
Placebo Comparator: Placebo
Matched placebo corn oil capsules
Other: Placebo
Other Names:
  • Matched placebo corn oil capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 12
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.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wei Jiang

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Wei Jiang, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

May 19, 2016

Study Completion (Actual)

December 2, 2016

Study Registration Dates

First Submitted

February 5, 2014

First Submitted That Met QC Criteria

February 5, 2014

First Posted (Estimate)

February 7, 2014

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

April 12, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00043654
  • R34MH097034-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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