Omega 3 for Treatment of Depression in Patients With Heart Failure

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-12-02

Brief Summary

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

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Detailed Description

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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

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2:1 EPA/DHA

400/200 EPA/DHA fish oil 2 grams

Group Type ACTIVE_COMPARATOR

2:1 EPA/DHA

Intervention Type DRUG

400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams

High EPA

Almost pure EPA 2 grams

Group Type ACTIVE_COMPARATOR

High EPA

Intervention Type DRUG

Placebo

Matched placebo corn oil capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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2:1 EPA/DHA

400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams

Intervention Type DRUG

High EPA

Intervention Type DRUG

Placebo

Intervention Type OTHER

Other Intervention Names

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400 EPA/200 DHA 2 grams An almost pure Eicosapentaenoic acid 2 grams Matched placebo corn oil capsules

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No