Safety and Effectiveness of Omega 3-Fatty Acids, EPA Versus DHA, for the Treatment of Major Depression

This study has been completed.
Sponsor:
Collaborator:
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
David Mischoulon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00361374
First received: August 4, 2006
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

This study examines the difference in the effectiveness of two natural compounds, eicosapentanoic (EPA) and docosahexanoic (DHA)omega-3 fatty acids, in treating major depressive disorder. Both types of omega-3 fatty acids are commonly found in fish oils. It is believed that a deficiency in these omega-3 fatty acids may lead to the development of major depression.


Condition Intervention Phase
Major Depressive Disorder
Dietary Supplement: eicosapentanoic acid
Dietary Supplement: docosahexanoic acid
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Omega-3 Fatty Acids for Treatment of Major Depression: Differential Effects of EPA and DHA, and Associated Biochemical and Immune Parameters

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Score on a depression rating scale over eight weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 196
Study Start Date: July 2006
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
EPA Omega-3 Fatty Acid, 1g/day
Dietary Supplement: eicosapentanoic acid
1 gram/day
Other Name: EPA Omega-3 Fatty Acid
Experimental: 2
DHA Omega-3 Fatty Acid, 1g/day
Dietary Supplement: docosahexanoic acid
1 gram/day
Other Name: DHA Omega-3 Fatty Acid
Placebo Comparator: 3
Placebo
Drug: Placebo
1 gram/day
Other Name: Placebo

Detailed Description:

The study lasts for eight weeks and involves four visits after the screen and baseline visits (biweekly). Participants will be randomized, or chosen by chance, to enter into one of three groups. People in the first group will take 1 g/day or EPA omega-3 fatty acid, those in the second group will take 1 g/day of DHA omega-3 fatty acid, and those in the third group will take a placebo. This study is double-blind, which means that neither the participant, nor the doctor, nor the research staff will know which group each person is in. At the end of the study the participant will be offered three months of follow-up care at the Depression Clinical and Research Program.

  Eligibility

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

Inclusion Criteria:

  • Men or women aged 18-80 years old.
  • Must meet criteria for current Major Depressive Disorder.

Exclusion Criteria:

  • Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease
  • History of seizure disorder.
  • Substance use disorders, including alcohol, active within the last six months (past history is OK).
  • History of multiple adverse drug reactions or allergy to the study drugs.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00361374

Locations
United States, Massachusetts
Depression Clinical Research Program, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Cedars-Sinai Medical Center
Investigators
Principal Investigator: David Mischoulon, MD, PhD Depression Clinical and Research Program, Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: David Mischoulon, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00361374     History of Changes
Other Study ID Numbers: 2005P002337, 1 RO1 MH74085-01A1
Study First Received: August 4, 2006
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Depression
Omega-3
Boston

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

ClinicalTrials.gov processed this record on April 15, 2014