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

Wei Jiang

Status and phase: Completed; Phase 3

Conditions: Depression

Treatments: Drug: 2:1 EPA/DHA; Drug: High EPA; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02057406

R34MH097034-01A1 (U.S. NIH Grant/Contract)

Pro00043654

Details and patient eligibility

About

Omega 3 supplements will improve depressive symptoms to a greater extent than placebo in heart failure patients with moderate to severe major depressive disorder.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 3 patient groups, including a placebo group

2:1 EPA/DHA

Active Comparator group

Description:

400/200 EPA/DHA fish oil 2 grams

Treatment:

Drug: 2:1 EPA/DHA

High EPA

Active Comparator group

Description:

Almost pure EPA 2 grams

Treatment:

Drug: High EPA

Placebo

Placebo Comparator group

Description:

Matched placebo corn oil capsules

Treatment:

Other: Placebo