Safety and Effectiveness of Omega 3-Fatty Acids, EPA Versus DHA, for the Treatment of Major Depression
July 17, 2014 updated by: David Mischoulon, MD, Massachusetts General Hospital
Omega-3 Fatty Acids for Treatment of Major Depression: Differential Effects of EPA and DHA, and Associated Biochemical and Immune Parameters
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
196
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Depression Clinical Research Program, Massachusetts General Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EPA
Eicosapentaenoic acid (EPA) Omega-3, 1g/day
|
1 gram/day
Other Names:
|
|
Experimental: DHA
Docosahexaenoic acid (DHA) Omega-3, 1g/day
|
1 gram/day
Other Names:
|
|
Placebo Comparator: Placebo
Placebo capsule (980mg soybean oil)
|
980 milligram/day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Mischoulon, MD, PhD, Depression Clinical and Research Program, Massachusetts General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
August 4, 2006
First Submitted That Met QC Criteria
August 4, 2006
First Posted (Estimate)
August 8, 2006
Study Record Updates
Last Update Posted (Estimate)
July 18, 2014
Last Update Submitted That Met QC Criteria
July 17, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005P002337
- 5R01MH074085 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.