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Omega-3 for Depression and Other Cardiac Risk Factors - 2

NCT02021669 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2019-09-04

Study results available
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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).

Conditions

Interventions

DRUG

Omega-3 supplement

Two grams of the EPA form of omega-3 daily and 50 mgs of sertraline daily for 10 weeks

DRUG

Placebo

Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Robert M Carney, PhD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-14
Primary Completion
2018-09-13
Completion
2018-09-13

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02021669 on ClinicalTrials.gov