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

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00096798
First received: November 15, 2004
Last updated: January 15, 2008
Last verified: January 2008
History of Changes
  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 Intervention Phase
Depressive Disorder
Depression
 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:

Drug Information available for: Icosapent
U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096798

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Principal Investigator: David Mischoulon, MD, PhD Massachusetts General Hospital
  More Information

No publications provided by National Center for Complementary and Alternative Medicine (NCCAM)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov 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 Alternative Medicine (NCCAM):
Fatty Acids, Omega-3
Antidepressive Agents
Eicosapentanoic Acid

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
 Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013