Omega 3 for Treatment of Depression in Patients With Heart Failure (OCEAN)
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depression | Drug: 2:1 EPA/DHA Drug: High EPA Other: Placebo | Phase 3 |
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 (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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 2:1 EPA/DHA
400/200 EPA/DHA fish oil 2 grams
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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
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Drug: High EPA
Other Name: An almost pure Eicosapentaenoic acid 2 grams |
Placebo Comparator: Placebo
Matched placebo corn oil capsules
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Other: Placebo
Other Name: Matched placebo corn oil capsules |
- 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.
- 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.

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

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
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 |
Principal Investigator: | Wei Jiang, MD | Duke University |
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 |
Heart Failure Depression Depressive Disorder Behavioral Symptoms |
Mood Disorders Mental Disorders Heart Diseases Cardiovascular Diseases |