Phase 3
Completed N=108
Omega 3 for Treatment of Depression in Patients With Heart Failure
Source: ClinicalTrials.gov NCT02057406 ↗Enrolled (actual)
108
Serious AEs
14.8%
Results posted
Jun 2017
Primary outcomePrimary: Endpoint Hamilton Depression Rating Scale (HAMD) Scores Adjusted for Age, Sex, Treatment Site, and Baseline HAMD Scores. — 15.1; 15.7; 14.9 units on a scale — p=0.74
◆ Published Evidence
Established
56citations · ~11 / year
Omega-3 fatty acids for depression in adults.
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.
Linked Publications (2)
-
Omega-3 fatty acids for depression in adults.
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Long-Chain Omega-3 Fatty Acid Supplements in Depressed Heart Failure Patients: Results of the OCEAN Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endpoint Hamilton Depression Rating Scale (HAMD) Scores Adjusted for Age, Sex, Treatment Site, and Baseline HAMD Scores. |
15.1; 15.7; 14.9 | 0.74 |
| PRIMARY Endpoint Red Blood Cell/Plasma EPA Values Adjusted for Age, Sex, Treatment Site, and Baseline Red Blood Cell/Plasma EPA Values. |
1.52; 1.86; 0.56 | <0.0001 sig |
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.
Data sourced from ClinicalTrials.gov (NCT02057406) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.