Omega-3 Fatty Acids to Improve Depression and Reduce Cardiovascular Risk Factors

Phase 3

Completed

• Conditions: Cardiovascular Diseases; Angina, Unstable; Depression; Heart Diseases; Myocardial Infarction
• Interventions: Drug: Sertraline/omega-3; Drug: Sertraline/Corn Oil

• Registration Number: NCT00116857
• Lead Sponsor: Washington University School of Medicine

Brief 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).

Detailed Description

BACKGROUND:
...

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-06-30
• Study First Posted: 2005-07-01
• Primary Completion: 2009-06
• Study Completion: 2009-11
• Results First Submitted: 2012-07-03
• Status Verified: 2012-09
• Results First Submitted QC: 2012-09-11
• Last Update Submitted: 2012-09-11
• Results First Posted: 2012-09-12
• Last Update Posted: 2012-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sertraline/omega-3 supplement	Sertraline/omega-3	-
Sertraline/corn oil	Sertraline/Corn Oil	-

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory-II	Measured at Baseline and 10 weeks	Beck Depression Inventory-II scores on a scale of 0 to 63, minimum score equals 0 maximum score equals 63. Higher value represents a worse outcome. Baseline scores are compared to scores after treatment.

Trial Locations

Locations (1)

Washington University; 🇺🇸 St. Louis, Missouri, United States