Omega 3 for Treatment of Depression in Patients With Heart Failure
Condition: Depression
MeSH terms: Heart Failure; Depression; Depressive Disorder
Intervention: 2:1 EPA/DHA; High EPA; Placebo
Intervention description: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 108.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.