NCT00096798

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2001

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2004

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

January 17, 2008

Status Verified

January 1, 2008

Enrollment Period

5.9 years

First QC Date

November 15, 2004

Last Update Submit

January 15, 2008

Conditions

Depressive DisorderDepression

Keywords

Fatty Acids, Omega-3Antidepressive AgentsEicosapentanoic Acid

Outcome Measures

Primary Outcomes (1)

  • Alleviation of depressive symptoms

Interventions

Ethyl-eicosapentanoic acid (ethyl-EPA)DRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major depressive disorder

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • 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.

    PMID: 34817851DERIVED

  • 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.

    PMID: 19709502DERIVED

MeSH Terms

Conditions

Depressive DisorderDepression

Interventions

eicosapentaenoic acid ethyl ester

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • David Mischoulon, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

November 15, 2004

First Posted

November 16, 2004

Study Start

September 1, 2001

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

January 17, 2008

Record last verified: 2008-01

Locations

US(1)