NCT00517036

Brief Summary

This study will test the effectiveness of two different kinds of omega-3 fatty acid dietary supplements in treating the symptoms of major depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P50-P75 for phase_3 depression

Timeline
Completed

Started Jul 2006

Typical duration for phase_3 depression

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

July 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

4.5 years

First QC Date

August 14, 2007

Last Update Submit

April 2, 2013

Conditions

Depression

Keywords

Major DepressionOmega-3Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Depression rating scale score on HAM-D 17, SCID Mood Module

    Both measured at Week 8

Study Arms (3)

A

EXPERIMENTAL

Participants will take EPA

Dietary Supplement: EPA omega-3 fatty acid

B

EXPERIMENTAL

Participants will take DHA

Dietary Supplement: DHA omega-3 fatty acid

C

PLACEBO COMPARATOR

Participants will take placebo

Dietary Supplement: Placebo comparator

Interventions

EPA omega-3 fatty acidDIETARY_SUPPLEMENT

1 gram per day of an EPA-enriched mixture for 8 weeks

A
DHA omega-3 fatty acidDIETARY_SUPPLEMENT

1 gram per day of pure DHA for 8 weeks

B
Placebo comparatorDIETARY_SUPPLEMENT

1 gram per day of an inactive substance for 8 weeks

C

Eligibility Criteria

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

You may qualify if:

  • Meets DSM-IV diagnostic criteria for major depressive disorder
  • A Clinical Global Impression-Severity (CGI-S) score greater than 3
  • A Baseline Hamilton-D-17 (HAM-D-17) (Hamilton, 1960,1967) score of ³ 15
  • Willing to use effective forms of contraception

You may not qualify if:

  • Pregnant
  • Suicidal or homicidal
  • Serious or unstable medical illness, including cardiovascular, liver, kidney, respiratory, endocrine, neuralgic, or blood disease
  • History of seizure disorder
  • History of organic mental disorders, substance abuse, schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder, or other psychotic disorders
  • History of inflammatory or auto-immune disorder (e.g., rheumatoid arthritis, multiple sclerosis, or cancer
  • History of multiple adverse drug reactions or an allergy to the study drugs
  • Mood-congruent or mood-incongruent psychotic features
  • Current use of other psychotropic drugs
  • Clinical or laboratory evidence of hypothyroidism
  • Failed to respond during the course of current major depressive episode to at least one adequate antidepressant trial, defined as 6 weeks or more of treatment with 40 mg/day of citalopram (or its antidepressant equivalent)
  • Received electroconvulsive therapy (ECT) within 6 months of study entry
  • Currently taking supplements enriched with omega-3 fatty acids (e.g., flax seed oil) or has taken at least 1 g/day of omega-3 fatty acids
  • Consuming a diet that contains more than 3g/day of omega-3 fatty acids at study entry
  • Taking anticoagulants or history of a bleeding disorder
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, 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, Nierenberg AA, Schettler PJ, Kinkead BL, Fehling K, Martinson MA, Hyman Rapaport M. A double-blind, randomized controlled clinical trial comparing eicosapentaenoic acid versus docosahexaenoic acid for depression. J Clin Psychiatry. 2015 Jan;76(1):54-61. doi: 10.4088/JCP.14m08986.

    PMID: 25272149DERIVED

MeSH Terms

Conditions

DepressionDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Mark H. Rapaport, MD

    Emory University

    PRINCIPAL INVESTIGATOR

  • David Mischoulon, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 14, 2007

First Posted

August 16, 2007

Study Start

July 1, 2006

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

US(1)