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

Primary Purpose

Depressive Disorder, Depression

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ethyl-eicosapentanoic acid (ethyl-EPA)
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring Fatty Acids, Omega-3, Antidepressive Agents, Eicosapentanoic Acid

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Major depressive disorder Exclusion Criteria: Serious comorbid psychiatric disorder Unstable medical illness Prior use of any omega-3 fatty acid product

Sites / Locations

  • Massachusetts General Hospital

Outcomes

Primary Outcome Measures

Alleviation of depressive symptoms

Secondary Outcome Measures

Full Information

First Posted
November 15, 2004
Last Updated
January 15, 2008
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00096798
Brief Title
Ethyl Eicosapentanoic Acid (Ethyl-EPA) for Treating Major Depression
Official Title
A Double-Blind, Placebo-Controlled Study of Ethyl Eicosapentanoic Acid (Ethyl-EPA) in Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Depression
Keywords
Fatty Acids, Omega-3, Antidepressive Agents, Eicosapentanoic Acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ethyl-eicosapentanoic acid (ethyl-EPA)
Primary Outcome Measure Information:
Title
Alleviation of depressive symptoms

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Major depressive disorder Exclusion Criteria: Serious comorbid psychiatric disorder Unstable medical illness Prior use of any omega-3 fatty acid product
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Mischoulon, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34817851
Citation
Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.
Results Reference
derived
PubMed Identifier
19709502
Citation
Mischoulon D, Papakostas GI, Dording CM, Farabaugh AH, Sonawalla SB, Agoston AM, Smith J, Beaumont EC, Dahan LE, Alpert JE, Nierenberg AA, Fava M. A double-blind, randomized controlled trial of ethyl-eicosapentaenoate for major depressive disorder. J Clin Psychiatry. 2009 Dec;70(12):1636-44. doi: 10.4088/JCP.08m04603. Epub 2009 Aug 25.
Results Reference
derived

Learn more about this trial

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

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