Omega 3 for Treatment of Depression in Patients With Heart Failure

• Status: Completed
• Trial end date: 2016-12-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wei Jiang
• Collaborator: National Institute of Mental Health (NIMH)

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.