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

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ClinicalTrials.gov Identifier: NCT00096798
Recruitment Status : Completed
First Posted : November 16, 2004
Last Update Posted : January 17, 2008
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Brief Summary:
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 or disease Intervention/treatment Phase
Depressive Disorder Depression Drug: Ethyl-eicosapentanoic acid (ethyl-EPA) Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of Ethyl Eicosapentanoic Acid (Ethyl-EPA) in Major Depressive Disorder
Study Start Date : September 2001
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Icosapent




Primary Outcome Measures :
  1. Alleviation of depressive symptoms


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096798


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: David Mischoulon, MD, PhD Massachusetts General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00096798     History of Changes
Other Study ID Numbers: K23AT001129 ( U.S. NIH Grant/Contract )
First Posted: November 16, 2004    Key Record Dates
Last Update Posted: January 17, 2008
Last Verified: January 2008

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders