Overview

This trial is active, not recruiting.

Condition depression
Treatments 400/200 epa/dha fish oil 2 grams, an almost pure epa 2 grams, matched placebo corn oil capsules
Phase phase 3
Sponsor Wei Jiang
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
400/200 EPA/DHA fish oil 2 grams
400/200 epa/dha fish oil 2 grams 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams
(Active Comparator)
Almost pure EPA 2 grams
an almost pure epa 2 grams An almost pure Eicosapentaenoic acid 2 grams
(Placebo Comparator)
Matched placebo corn oil capsules
matched placebo corn oil capsules

Primary Outcomes

Measure
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

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Duke University.