At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 144 enrolled
Drug / intervention
Omega-3 supplement +1 moredrug
Likely dose
Placebo 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Omega-3 for Depression and Other Cardiac Risk Factors-2
In Brief
A Phase 2 clinical trial evaluating Omega-3 supplement and Placebo for Depression. Completed, enrolled 144 participants across 1 site.
Detailed Summary
The purpose of this 10 week randomized, placebo-controlled, double-blind clinical trial is to determine whether antidepressant augmentation with two grams of EPA omega-3 per day is superior to antidepressant therapy alone for major depression in patients with coronary heart disease (CHD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 2013
Enrollment StartMay 2014
Primary CompletionSep 2018
TodayJul 2026
First PostedDec 27, 2013
Enrollment StartMay 14, 2014
Primary CompletionSep 13, 2018
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 12.5 years ago
Interventions
Omega-3 supplementdrug
Two grams of the EPA form of omega-3 daily and 50 mgs of sertraline daily for 10 weeks
Placebodrug
Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.