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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
Sex
Ages
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
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
Primary purpose
Allocation
Interventional model
Masking
108 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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