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

Primary Purpose

Depression

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
2:1 EPA/DHA
High EPA
Placebo
Sponsored by
Wei Jiang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of North Carolina at Chapel Hill
  • Duke University Medical Center
  • Thomas Jefferson University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

2:1 EPA/DHA

High EPA

Placebo

Arm Description

400/200 EPA/DHA fish oil 2 grams

Almost pure EPA 2 grams

Matched placebo corn oil capsules

Outcomes

Primary Outcome Measures

Endpoint Hamilton Depression Rating Scale (HAMD) Scores Adjusted for Age, Sex, Treatment Site, and Baseline HAMD Scores.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 5, 2014
Last Updated
April 12, 2018
Sponsor
Wei Jiang
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02057406
Brief Title
Omega 3 for Treatment of Depression in Patients With Heart Failure
Acronym
OCEAN
Official Title
Omega 3 for Comorbid Depression and Heart Failure Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
May 19, 2016 (Actual)
Study Completion Date
December 2, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wei Jiang
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2:1 EPA/DHA
Arm Type
Active Comparator
Arm Description
400/200 EPA/DHA fish oil 2 grams
Arm Title
High EPA
Arm Type
Active Comparator
Arm Description
Almost pure EPA 2 grams
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched placebo corn oil capsules
Intervention Type
Drug
Intervention Name(s)
2:1 EPA/DHA
Other Intervention Name(s)
400 EPA/200 DHA 2 grams
Intervention Description
400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams
Intervention Type
Drug
Intervention Name(s)
High EPA
Other Intervention Name(s)
An almost pure Eicosapentaenoic acid 2 grams
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matched placebo corn oil capsules
Primary Outcome Measure Information:
Title
Endpoint Hamilton Depression Rating Scale (HAMD) Scores Adjusted for Age, Sex, Treatment Site, and Baseline HAMD Scores.
Description
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.
Time Frame
Week 12
Title
Endpoint Red Blood Cell/Plasma EPA Values Adjusted for Age, Sex, Treatment Site, and Baseline Red Blood Cell/Plasma EPA Values.
Description
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.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Jiang, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34817851
Citation
Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.
Results Reference
derived
PubMed Identifier
30098961
Citation
Jiang W, Whellan DJ, Adams KF, Babyak MA, Boyle SH, Wilson JL, Patel CB, Rogers JG, Harris WS, O'Connor CM. Long-Chain Omega-3 Fatty Acid Supplements in Depressed Heart Failure Patients: Results of the OCEAN Trial. JACC Heart Fail. 2018 Oct;6(10):833-843. doi: 10.1016/j.jchf.2018.03.011. Epub 2018 Aug 8.
Results Reference
derived

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Omega 3 for Treatment of Depression in Patients With Heart Failure

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