Depressive DisorderPhase 3NCT00096798
Ethyl Eicosapentanoic Acid (Ethyl-EPA) for Treating Major Depression
A Phase 3 study testing Ethyl-eicosapentanoic acid (ethyl-EPA) in people with Depressive Disorder and Depression, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to examine the effectiveness of ethyl-eicosapentanoic acid (ethyl-EPA), an omega-3 fatty acid, in treating depression. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depressive Disorder, Depression
- What is being tested?
- Ethyl-eicosapentanoic acid (ethyl-EPA)
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Aug 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Major depressive disorder
Who cannot join
- Serious comorbid psychiatric disorder
- Unstable medical illness
- Prior use of any omega-3 fatty acid product
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Double-Blind, Placebo-Controlled Study of Ethyl Eicosapentanoic Acid (Ethyl-EPA) in Major Depressive Disorder
The purpose of this study is to examine the effectiveness of ethyl-eicosapentanoic acid (ethyl-EPA), an omega-3 fatty acid, in treating depression.
Read the detailed description
Evidence suggests that omega-3 fatty acids may help reduce symptoms of depression. This study will determine whether ethyl-EPA, an omega-3 fatty acid, can be used safely and effectively to treat major depression.
Participants will be randomly assigned to receive either ethyl EPA-containing pills or placebo daily for 8 weeks. Each week, participants will be asked to complete questionnaires which will be used to assess the severity of their depression.
- Conditions
- Depressive Disorder, Depression
- Being tested
- Ethyl-eicosapentanoic acid (ethyl-EPA)
- Keywords
- Fatty Acids, Omega-3, Antidepressive Agents, Eicosapentanoic Acid
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethyl-eicosapentanoic acid (ethyl-EPA)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Alleviation of depressive symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2004 (estimated)
- Study startSep 2001
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- 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
- Double blind
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- David Mischoulon, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096798
- Sponsor's protocol ID
- K23AT001129
- Status last verified
- Jan 2008
- First submitted
- 15 Nov 2004
- Last updated
- 17 Jan 2008
- Results posted
- No
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 34817851Mischoulon D, Papakostas GI, Dording CM, Farabaugh AH, Sonawalla SB, Agoston AM, Smith J, Beaumont EC, Dahan LE, Alpert JE, Nierenberg AA, Fava M. A double-blind, randomized controlled trial of ethyl-eicosapentaenoate for major depressive disorder. J Clin Psychiatry. 2009 Dec;70(12):1636-44. doi: 10.4088/JCP.08m04603. Epub 2009 Aug 25.
PubMed 19709502
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study of Ethyl Eicosapentanoic Acid (Ethyl-EPA) in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00096798
- Acronym / sponsor ID
- K23AT001129
- Conditions
- Depressive Disorder, Depression
- Keywords
- Fatty Acids, Omega-3, Antidepressive Agents, Eicosapentanoic Acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Sep 2001
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 16 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effectiveness of ethyl-eicosapentanoic acid (ethyl-EPA), an omega-3 fatty acid, in treating depression.
Detailed description
Evidence suggests that omega-3 fatty acids may help reduce symptoms of depression. This study will determine whether ethyl-EPA, an omega-3 fatty acid, can be used safely and effectively to treat major depression.
Participants will be randomly assigned to receive either ethyl EPA-containing pills or placebo daily for 8 weeks. Each week, participants will be asked to complete questionnaires which will be used to assess the severity of their depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Major depressive disorder
Key exclusion criteria (3 listed)
- Serious comorbid psychiatric disorder
- Unstable medical illness
- Prior use of any omega-3 fatty acid product
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 |
|---|---|---|
| Ethyl-eicosapentanoic acid (ethyl-EPA) | Drug | – |
Primary outcome
Alleviation of depressive symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2008.
- 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.
- Derived from this study: PubMed 19709502Mischoulon D, Papakostas GI, Dording CM, Farabaugh AH, Sonawalla SB, Agoston AM, Smith J, Beaumont EC, Dahan LE, Alpert JE, Nierenberg AA, Fava M. A double-blind, randomized controlled trial of ethyl-eicosapentaenoate for major depressive disorder. J Clin Psychiatry. 2009 Dec;70(12):1636-44. doi: 10.4088/JCP.08m04603. Epub 2009 Aug 25.
Related trials for Depressive Disorder
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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
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 Ethyl-eicosapentanoic acid (ethyl-EPA) in people with Depressive Disorder and Depression, run by National Center for Complementary and Integrative Health (NCCIH) 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 1 inclusion and 3 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 17 Jan 2008. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Alleviation of depressive symptoms. 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 NCT00096798, which also lists 2 linked publications.
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 17 Jan 2008.