DepressionPhase 3OCEANNCT02057406

Omega 3 for Treatment of Depression in Patients With Heart Failure

A Phase 3 study testing 2:1 EPA/DHA and High EPA in people with Depression, run by Wei Jiang at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Depression
What is being tested?: 2:1 EPA/DHA and High EPA
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 108 participants
Where: 3 sitesUnited States
Study dates: May 2014to 2 Dec 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 14Show fewer

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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Depression
Being tested: 2:1 EPA/DHA, High EPA, Placebo
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

2:1 EPA/DHADrug
Also called 400 EPA/200 DHA 2 grams
400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams
High EPADrug
Also called An almost pure Eicosapentaenoic acid 2 grams
PlaceboOther
Also called Matched placebo corn oil capsules

Study groups in NCT02057406
Study group	Role	What they receive
2:1 EPA/DHA	Active comparator	400/200 EPA/DHA fish oil 2 grams Receives: Drug: 2:1 EPA/DHA
High EPA	Active comparator	Almost pure EPA 2 grams Receives: Drug: High EPA
Placebo	Placebo comparator	Matched placebo corn oil capsules Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 12
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.
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 20142 Dec 2016

First posted7 Feb 2014 (estimated)
Study startMay 2014
Primary completion19 May 2016
Study completion2 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02057406
Sponsor's protocol ID: Pro00043654
Other IDs: R34MH097034-01A1
Acronym: OCEAN
Status last verified: Apr 2018
First submitted: 5 Feb 2014
Last updated: 14 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 34817851
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.
PubMed 30098961

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Omega 3 for Comorbid Depression and Heart Failure Treatment
ClinicalTrials.gov ID: NCT02057406
Acronym / sponsor ID: OCEAN / Pro00043654
Conditions: Depression
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Wei JiangUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: May 2014 (actual)
Primary completion: 19 May 2016 (actual)
Study completion: 2 Dec 2016 (actual)
First posted: 7 Feb 2014 (estimated)
Results: Posted 12 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
2:1 EPA/DHA	Active comparator	Drug: 2:1 EPA/DHA400/200 EPA/DHA fish oil 2 grams
High EPA	Active comparator	Drug: High EPAAlmost pure EPA 2 grams
Placebo	Placebo comparator	Other: PlaceboMatched placebo corn oil capsules

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
2:1 EPA/DHAAlso: 400 EPA/200 DHA 2 grams400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams	Drug	2:1 EPA/DHA
High EPAAlso: An almost pure Eicosapentaenoic acid 2 grams	Drug	High EPA
PlaceboAlso: Matched placebo corn oil capsules	Other	Placebo

Primary outcome

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.

Results and safety

Results posted to the registry on 12 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2:1 EPA/DHA	36	35
High EPA	36	33
Placebo	36	32

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

Time frame: Week 12. Mean (Standard Error). Unit: units on a scale

Measure	2:1 EPA/DHA n = 36	High EPA n = 36	Placebo n = 36
Value	15.1 (0.9)	15.7 (0.9)	14.9 (0.9)

2:1 EPA/DHA vs Placebo: p = 0.74, ANCOVA
High EPA vs Placebo: p = 0.45, ANCOVA

Primary outcome: 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. Mean (Standard Error). Unit: percentage of total fatty acids

Measure	2:1 EPA/DHA n = 36	High EPA n = 36	Placebo n = 36
Value	1.52 (0.15)	1.86 (0.15)	0.56 (0.15)

2:1 EPA/DHA vs High EPA vs Placebo: p <0.0001, ANCOVA
2:1 EPA/DHA vs High EPA: p = 0.12, ANCOVA

Population analysed: The numbers at baseline reflect the total number of patients who provided samples for the assay of omega 3 percentage of total fatty acids. The numbers at endpoint reflect the total number of patients included in the intention to treat analysis.

Adverse events

Time frame: Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2:1 EPA/DHA	4 of 36 (11.1%)	7 of 36 (19.4%)	1 of 36
High EPA	5 of 36 (13.9%)	6 of 36 (16.7%)	0 of 36
Placebo	7 of 36 (19.4%)	10 of 36 (27.8%)	1 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34817851Appleton 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.
Derived from this study: PubMed 30098961Jiang 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wei Jiang, MD principal investigator

Duke University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 2:1 EPA/DHA and High EPA in people with Depression, run by Wei Jiang at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endpoint Hamilton Depression Rating Scale (HAMD) Scores Adjusted for Age, Sex, Treatment Site, and Baseline HAMD Scores. (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02057406, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.