Major Depressive DisorderPhase 3NCT00361374
Safety and Effectiveness of Omega 3-Fatty Acids, EPA Versus DHA, for the Treatment of Major Depression
A Phase 3 study testing eicosapentaenoic acid and docosahexaenoic acid in people with Major Depressive Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- eicosapentaenoic acid and docosahexaenoic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Mar 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 18-80 years old.
- Must meet criteria for current Major Depressive Disorder.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Depression Clinical Research Program, Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- eicosapentaenoic acid, docosahexaenoic acid, Placebo
- Keywords
- Depression, Omega-3, Boston
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eicosapentaenoic acidDietary supplement
Also called EPA, Omega-3 Fatty Acid, ProEPAXtra
1 gram/day
docosahexaenoic acidDietary supplement
Also called DHA, Omega-3 Fatty Acid, ProDHA
1 gram/day
PlaceboDrug
Also called Placebo, Soybean oil
980 milligram/day
| Study group | Role | What they receive |
|---|---|---|
| EPA | Experimental | Eicosapentaenoic acid (EPA) Omega-3, 1g/day Receives: Dietary Supplement: eicosapentaenoic acid |
| DHA | Experimental | Docosahexaenoic acid (DHA) Omega-3, 1g/day Receives: Dietary Supplement: docosahexaenoic acid |
| Placebo | Placebo comparator | Placebo capsule (980mg soybean oil) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionFeb 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Mischoulon, MD, Massachusetts General Hospital
- Investigators
- David Mischoulon, MD, PhD, Principal investigator, Depression Clinical and Research Program, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361374
- Sponsor's protocol ID
- 2005P002337
- Other IDs
- 5R01MH074085
- Status last verified
- Jul 2014
- First submitted
- 4 Aug 2006
- Last updated
- 18 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 34817851
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acids for Treatment of Major Depression: Differential Effects of EPA and DHA, and Associated Biochemical and Immune Parameters
- ClinicalTrials.gov ID
- NCT00361374
- Acronym / sponsor ID
- 2005P002337
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Omega-3, Boston
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Cedars-Sinai Medical Center, National Institute of Mental Health (NIMH)
- Study start
- Jul 2006
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Aug 2006 (estimated)
- Results
- Posted 18 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EPA | Experimental | Dietary Supplement: eicosapentaenoic acidEicosapentaenoic acid (EPA) Omega-3, 1g/day |
| DHA | Experimental | Dietary Supplement: docosahexaenoic acidDocosahexaenoic acid (DHA) Omega-3, 1g/day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule (980mg soybean oil) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men or women aged 18-80 years old.
- Must meet criteria for current Major Depressive Disorder.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eicosapentaenoic acidAlso: EPA, Omega-3 Fatty Acid, ProEPAXtra1 gram/day | Dietary supplement | EPA |
| docosahexaenoic acidAlso: DHA, Omega-3 Fatty Acid, ProDHA1 gram/day | Dietary supplement | DHA |
| PlaceboAlso: Placebo, Soybean oil980 milligram/day | Drug | Placebo |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34817851Appleton 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.
- The Depression Clinical and Research Program at Massachusetts General HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Mischoulon, MD, PhD principal investigator
Depression Clinical and Research Program, Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing eicosapentaenoic acid and docosahexaenoic acid in people with Major Depressive Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on a Depression Severity Rating Scale Over Eight Weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00361374, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2014.