Safety and Effectiveness of Omega 3-Fatty Acids, EPA Versus DHA, for the Treatment of Major Depression
Omega-3 Fatty Acids for Treatment of Major Depression: Differential Effects of EPA and DHA, and Associated Biochemical and Immune Parameters
2 other identifiers
interventional
196
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 major-depressive-disorder
Started Jul 2006
Longer than P75 for phase_3 major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 4, 2006
CompletedFirst Posted
Study publicly available on registry
August 8, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
July 18, 2014
CompletedJuly 18, 2014
July 1, 2014
6.6 years
August 4, 2006
April 3, 2014
July 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Score on a Depression Severity Rating Scale Over Eight 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
Study Arms (3)
EPA
EXPERIMENTALEicosapentaenoic acid (EPA) Omega-3, 1g/day
DHA
EXPERIMENTALDocosahexaenoic acid (DHA) Omega-3, 1g/day
Placebo
PLACEBO COMPARATORPlacebo capsule (980mg soybean oil)
Interventions
1 gram/day
Eligibility Criteria
You may qualify if:
- Men or women aged 18-80 years old.
- Must meet criteria for current Major Depressive Disorder.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Cedars-Sinai Medical Centercollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Depression Clinical Research Program, Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was underpowered due to lower than expected recruitment. The high placebo response rate may have impeded signal detection. The n-3 preparations were not pure, but "enriched" for one n-3 or the other, and contained other FAs.
Results Point of Contact
- Title
- Dr David Mischoulon, Director of Research, Depression Clinical and Research Program
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
David Mischoulon, MD, PhD
Depression Clinical and Research Program, Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 4, 2006
First Posted
August 8, 2006
Study Start
July 1, 2006
Primary Completion
February 1, 2013
Study Completion
March 1, 2013
Last Updated
July 18, 2014
Results First Posted
July 18, 2014
Record last verified: 2014-07