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

This study has been completed.
Sponsor:
Collaborators:
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: July 17, 2014
Last verified: July 2014
  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: eicosapentaenoic acid
Dietary Supplement: docosahexaenoic 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 Severity Rating Scale Over Eight Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change in score on 17-item Hamilton D depression severity rating scale over 8 weeks of treatment. Scores were obtained every 2 weeks for 8 weeks. The total sum score of the 17 items is used to assess depressive severity. Possible total scores range from 0-52, with a higher score indicating greater depressive severity. Scores of 7 or less are indicative of full remission (i.e. no depression). Scores of 8-15 indicate mild depression; scores of 16-25 indicate moderate depression; scores of 25 or greater indicate severe depression. Mixed model repeated measures analysis (MMRM) was used to examine treatment group effect on changes from baseline to week 8 in Hamilton D scores. Models included subjects as a random effect, and treatment group and study week as fixed effects. An auto-regressive covariance structure was used because it provided the best fit to the data. Site and baseline score were included as covariates in all models.


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: EPA
Eicosapentaenoic acid (EPA) Omega-3, 1g/day
Dietary Supplement: eicosapentaenoic acid
1 gram/day
Other Name: EPA, Omega-3 Fatty Acid, ProEPAXtra
Experimental: DHA
Docosahexaenoic acid (DHA) Omega-3, 1g/day
Dietary Supplement: docosahexaenoic acid
1 gram/day
Other Name: DHA, Omega-3 Fatty Acid, ProDHA
Placebo Comparator: Placebo
Placebo capsule (980mg soybean oil)
Drug: Placebo
980 milligram/day
Other Name: Placebo, Soybean oil

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 5R01MH074085
Study First Received: August 4, 2006
Results First Received: April 3, 2014
Last Updated: July 17, 2014
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
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 24, 2014