Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Ethyl Eicosapentanoic Acid (Ethyl-EPA) for Treating Major Depression

This study has been completed.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH) Identifier:
First received: November 15, 2004
Last updated: January 15, 2008
Last verified: January 2008

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 Intervention Phase
Depressive Disorder
Drug: Ethyl-eicosapentanoic acid (ethyl-EPA)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of Ethyl Eicosapentanoic Acid (Ethyl-EPA) in Major Depressive Disorder

Resource links provided by NLM:

Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

Primary Outcome Measures:
  • Alleviation of depressive symptoms

Estimated Enrollment: 80
Study Start Date: September 2001
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Major depressive disorder

Exclusion Criteria:

  • Serious comorbid psychiatric disorder
  • Unstable medical illness
  • Prior use of any omega-3 fatty acid product
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00096798

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Principal Investigator: David Mischoulon, MD, PhD Massachusetts General Hospital
  More Information

No publications provided by National Center for Complementary and Integrative Health (NCCIH)

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00096798     History of Changes
Other Study ID Numbers: K23 AT001129
Study First Received: November 15, 2004
Last Updated: January 15, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Fatty Acids, Omega-3
Antidepressive Agents
Eicosapentanoic Acid

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders processed this record on February 27, 2015