Back to resultsSafety and Effectiveness of Omega 3-Fatty Acids, EPA Versus DHA, for the Treatment of Major Depression
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
eicosapentaenoic acid
docosahexaenoic acid
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Omega-3, Boston
Eligibility 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.
Sites / Locations
- Depression Clinical Research Program, Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
EPA
DHA
Placebo
Arm Description
Eicosapentaenoic acid (EPA) Omega-3, 1g/day
Docosahexaenoic acid (DHA) Omega-3, 1g/day
Placebo capsule (980mg soybean oil)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00361374
First Posted
August 4, 2006
Last Updated
July 17, 2014
Sponsor
Massachusetts General Hospital
Collaborators
Cedars-Sinai Medical Center, National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00361374
Brief Title
Safety and Effectiveness of Omega 3-Fatty Acids, EPA Versus DHA, for the Treatment of Major Depression
Official Title
Omega-3 Fatty Acids for Treatment of Major Depression: Differential Effects of EPA and DHA, and Associated Biochemical and Immune Parameters
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Cedars-Sinai Medical Center, National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Omega-3, Boston
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EPA
Arm Type
Experimental
Arm Description
Eicosapentaenoic acid (EPA) Omega-3, 1g/day
Arm Title
DHA
Arm Type
Experimental
Arm Description
Docosahexaenoic acid (DHA) Omega-3, 1g/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule (980mg soybean oil)
Intervention Type
Dietary Supplement
Intervention Name(s)
eicosapentaenoic acid
Other Intervention Name(s)
EPA, Omega-3 Fatty Acid, ProEPAXtra
Intervention Description
1 gram/day
Intervention Type
Dietary Supplement
Intervention Name(s)
docosahexaenoic acid
Other Intervention Name(s)
DHA, Omega-3 Fatty Acid, ProDHA
Intervention Description
1 gram/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo, Soybean oil
Intervention Description
980 milligram/day
Primary Outcome Measure Information:
Title
Score on a Depression Severity Rating Scale Over Eight Weeks
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Mischoulon, MD, PhD
Organizational Affiliation
Depression Clinical and Research Program, Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Depression Clinical Research Program, Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34817851
Citation
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.
Results Reference
derived
Links:
URL
http://www.massgeneral.org/depression
Description
The Depression Clinical and Research Program at Massachusetts General Hospital
Learn more about this trial
Safety and Effectiveness of Omega 3-Fatty Acids, EPA Versus DHA, for the Treatment of Major Depression
We'll reach out to this number within 24 hrs