At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 122 enrolled
Drug / intervention
Sertraline/omega-3 +1 moredrug
Likely dose
Sertraline 50 mg once daily plus omega-3 2 grams dailyAI-extracted
Key inclusion· 3
- ✓Current major depressive episode meeting DSM-IV criteria
- ✓Depression severity: Beck Depression Inventory II score ≥15
- ✓History of acute myocardial infarction, unstable angina, or documented coronary disease
Key exclusion· 10
- ✕Active psychosis, dementia, or bipolar disorder
- ✕Current alcohol or drug abuse
- ✕Already taking omega-3 supplements
- ✕Severe hypertriglyceridemia (>400 mg/dL)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Omega-3 for Depression and Other Cardiac Risk Factors
In Brief
A Phase 3 clinical trial evaluating Sertraline/omega-3 and Sertraline/Corn Oil for Cardiovascular Diseases and 4 related conditions. Completed, enrolled 122 participants across 1 site.
Detailed Summary
This study will determine the effects of omega-3 fatty acid (FA) augmentation of sertraline on depression and cardiac endpoints after myocardial infarction (MI).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular Diseases, Depression, Heart Diseases, Myocardial Infarction, Angina, Unstable
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2005
First PostedJul 2005
Primary CompletionJun 2009
Study CompletionNov 2009
TodayJul 2026
First PostedJul 1, 2005
Enrollment StartFeb 1, 2005
Primary CompletionJun 1, 2009
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 21.0 years ago
Interventions
Sertraline/omega-3drug
Sertraline (50 mgs) plus omega-3 (2 grams)
Sertraline/Corn Oildrug
Sertraline (50 mgs) plus corn oil (2 grams) (placebo)