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

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ClinicalTrials.gov Identifier: NCT00361374
Recruitment Status : Completed
First Posted : August 8, 2006
Results First Posted : July 18, 2014
Last Update Posted : July 18, 2014
Sponsor:
Collaborators:
Cedars-Sinai Medical Center
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
David Mischoulon, MD, Massachusetts General Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Major Depressive Disorder Dietary Supplement: eicosapentaenoic acid Dietary Supplement: docosahexaenoic acid Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2006
Actual Primary Completion Date : February 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Score on a Depression Severity Rating Scale Over Eight Weeks [ Time Frame: 8 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: David Mischoulon, MD, PhD Depression Clinical and Research Program, Massachusetts General Hospital

Additional Information:
Responsible Party: David Mischoulon, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00361374     History of Changes
Other Study ID Numbers: 2005P002337
5R01MH074085 ( U.S. NIH Grant/Contract )
First Posted: August 8, 2006    Key Record Dates
Results First Posted: July 18, 2014
Last Update Posted: July 18, 2014
Last Verified: July 2014

Keywords provided by David Mischoulon, MD, Massachusetts General Hospital:
Depression
Omega-3
Boston

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