Phase 3
N=108
Omega 3 for Treatment of Depression in Patients With Heart Failure
Depression
Bottom Line
View on ClinicalTrials.gov: NCT02057406 ↗Enrolled (actual)
108
Serious AEs
14.8%
Results posted
Jun 2017
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 2:1 EPA/DHA (Drug); High EPA (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Wei Jiang
- Primary completion
- May 2016
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 |
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.
Data sourced from ClinicalTrials.gov (NCT02057406). 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.