NCT02057406

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P25-P50 for phase_3 depression

Timeline
Completed

Started May 2014

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2016

Completed
6 months until next milestone

Results Posted

Study results publicly available

June 12, 2017

Completed
Last Updated

May 14, 2018

Status Verified

April 1, 2018

Enrollment Period

2.1 years

First QC Date

February 5, 2014

Results QC Date

May 18, 2017

Last Update Submit

April 12, 2018

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Week 12

Study Arms (3)

2:1 EPA/DHA

ACTIVE COMPARATOR

400/200 EPA/DHA fish oil 2 grams

Drug: 2:1 EPA/DHA

High EPA

ACTIVE COMPARATOR

Almost pure EPA 2 grams

Drug: High EPA

Placebo

PLACEBO COMPARATOR

Matched placebo corn oil capsules

Other: Placebo

Interventions

2:1 EPA/DHADRUG

400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams

Also known as: 400 EPA/200 DHA 2 grams
2:1 EPA/DHA
High EPADRUG
Also known as: An almost pure Eicosapentaenoic acid 2 grams
High EPA
PlaceboOTHER
Also known as: Matched placebo corn oil capsules
Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (2)

  • 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.

    PMID: 34817851DERIVED

  • 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.

    PMID: 30098961DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Dr. Wei Jiang
Organization
Duke University Medical Center
jiang001@mc.duke.edu
919-668-0762

Study Officials

  • Wei Jiang, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 5, 2014

First Posted

February 7, 2014

Study Start

May 1, 2014

Primary Completion

May 19, 2016

Study Completion

December 2, 2016

Last Updated

May 14, 2018

Results First Posted

June 12, 2017

Record last verified: 2018-04

Locations

US(3)