Omega 3 for Treatment of Depression in Patients With Heart Failure
This trial is active, not recruiting.
|Treatments||400/200 epa/dha fish oil 2 grams, an almost pure epa 2 grams, matched placebo corn oil capsules|
|Collaborator||National Institute of Mental Health (NIMH)|
|Start date||May 2014|
|End date||December 2016|
|Trial size||200 participants|
|Trial identifier||NCT02057406, Pro00043654, R34MH097034-01A1|
Omega 3 supplements will improve depressive symptoms to a greater extent than placebo in heart failure patients with moderate to severe major depressive disorder.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Chapel Hill, NC||University of North Carolina at Chapel Hill||no longer recruiting|
|Durham, NC||Duke University Medical Center||no longer recruiting|
|Philadelphia, PA||Thomas Jefferson University||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Change in Hamilton Depression Rating Scale (HDRS) score
time frame: Baseline through week 12
Change in Red Blood Cell/Plasma EPA
time frame: Baseline through week 12
Male or female participants at least 21 years old.
Inclusion Criteria: - Adult male and female patients, age greater than or equal to 21 years - Diagnosis of Major Depressive Disorder determined by the 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 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., 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.
|Official title||Omega 3 for Comorbid Depression and Heart Failure Treatment|
|Principal investigator||Wei Jiang, MD|
|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.|
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