Omega 3 for Treatment of Depression in Patients With Heart Failure

Depression Clinical Trial

— OCEAN  

Official title:

Omega 3 for Comorbid Depression and Heart Failure Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02057406
• Other study ID #: Pro00043654
• Secondary ID: R34MH097034-01A1
• Status: Completed
• Phase: Phase 3
• Start date: May 2014
• Est. completion date: December 2, 2016

Study information

• Verified date: April 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 2, 2016
• Est. primary completion date: May 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Heart Failure

Intervention

Drug:
• 2:1 EPA/DHA
400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams
• High EPA

Other:
• Placebo

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Duke University Medical Center	Durham	North Carolina
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Wei Jiang	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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