Phase 3
Completed N=122
Omega-3 Fatty Acids to Improve Depression and Reduce Cardiovascular Risk Factors
Source: ClinicalTrials.gov NCT00116857 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcomePrimary: Beck Depression Inventory-II — 16.1; 14.8 units on a scale
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Beck Depression Inventory-II |
16.1; 14.8 | — |
Eligibility Criteria
Inclusion Criteria
- Meets the DSM-IV criteria for a current major depressive episode
- Score of 15 or higher on the Beck Depression Inventory II
- History of acute myocardial infarction, unstable angina, or documented coronary disease
Exclusion Criteria
- Physician or patient refusal
- Lives far away from study site
- Current alcohol or drug abuse
- Psychosis, dementia, or bipolar disorder
- Already taking Omega-3
- Medically ill or disabled such that patient is unable to participate
- Comorbid illness likely to be fatal within 1 year of study entry
- Seizure disorder or takes anticonvulsants
- Pregnant or breast feeding
- Liver or kidney disease
- Severe hypertriglyceridemia (greater than 400 mg/dL)
- Bleeding or clotting disorder
- Type 2 diabetes with a hemoglobin A1c (HbA1c) level greater than 10
- Taking lithium or monoamine oxidase inhibitor (MAO-I)
Data sourced from ClinicalTrials.gov (NCT00116857). 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.