Clinical Trial: Ethyl Eicosapentanoic Acid (ethyl-EPA) for Treating Major Depression

This study is currently recruiting patients.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)

Purpose

The purpose of this study is to examine the effectiveness of ethyl-eicosapentanoic acid (ethyl-EPA), an omega-3 fatty acid, in treating depression.

Condition Treatment or Intervention Phase
Depressive Disorder
Depression
 Drug: Ethyl-eicosapentanoic acid (ethyl-EPA)
Phase III

MedlinePlus related topics:  Depression;   Mental Health

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Double-Blind, Placebo-Controlled Study of Ethyl Eicosapentanoic Acid (ethyl-EPA) in Major Depressive Disorder

Further Study Details: 
Primary Outcomes: Alleviation of depressive symptoms
Expected Total Enrollment:  80

Study start: September 2001;  Expected completion: August 2006

Evidence suggests that omega-3 fatty acids may help reduce symptoms of depression. This study will determine whether ethyl-EPA, an omega-3 fatty acid, can be used safely and effectively to treat major depression.

Participants will be randomly assigned to receive either ethyl EPA-containing pills or placebo daily for 8 weeks. Each week, participants will be asked to complete questionnaires which will be used to assess the severity of their depression.

Eligibility

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Major depressive disorder

Exclusion Criteria:

  • Serious comorbid psychiatric disorder
  • Unstable medical illness
  • Prior use of any omega-3 fatty acid product

Location and Contact Information


Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Recruiting
David Mischoulon, MD, PhD  617-724-5198    dmischoulon@partners.org 
David Mischoulon, MD, PhD,  Principal Investigator
Maurizio Fava, MD,  Sub-Investigator

Study chairs or principal investigators

David Mischoulon, MD, PhD,  Principal Investigator,  Massachusetts General Hospital   

More Information

Study ID Numbers:  K23 AT-001129-03
Record last reviewed:  February 2005
Last Updated:  February 10, 2005
Record first received:  November 15, 2004
ClinicalTrials.gov Identifier:  NCT00096798
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005