DepressionPhase 2/3NCT00711971
Does Fish Oil Prevent Depression in Pregnancy and Postpartum?
A Phase 2/3 study testing EPA-rich fish oil supplement and DHA-rich fish oil supplement in people with Depression, run by University of Michigan at 1 site in United States.
Trial summary
This study is designed to test whether an alternative medicine treatment, fish oil, will prevent depressive symptoms in pregnant and postpartum women who have been found to be at risk for depression. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- EPA-rich fish oil supplement and DHA-rich fish oil supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jan 2013
- Phase
- Phase 2/3
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women who are more than 12 weeks pregnant but less than 20 weeks pregnant
- Women who are found to be at risk for depression
- Women who have been treated for depression in the past
- Women with depression after a previous pregnancy
- Women planning to deliver at University of Michigan Hospital
Who cannot join
- Women who have major depression or other psychiatric disorders (current substance abuse, schizophrenia, bipolar disorder) at the time of screening
- Women who are currently taking anti-depressant or other psychiatric medications
- Women who routinely eat more than 2 fish meals per week
- Women on anticoagulants (blood thinners)
- Women currently taking omega-3 fatty acid dietary supplements (fish oil, flaxseed oil or cod liver oil)
- Women with bleeding disorders such as von Willebrand's disease
Show all 10Show fewer
- Women under the age of 18
- Women with a multiple gestation (twins, for example)
- Women planning to deliver at another hospital
- Women planning to move away before 6 weeks after delivery
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: Does EPA or DHA Prevent Depressive Symptoms in Pregnancy and Postpartum?
This study is designed to test whether an alternative medicine treatment, fish oil, will prevent depressive symptoms in pregnant and postpartum women who have been found to be at risk for depression. Epidemiologists have observed that people who live in countries where people on average eat a diet high in fish have a lower risk of depression than people who live in populations that eat less fish. Postpartum depression is also less common in these countries. The omega-3 fatty acids found in fish oil are thought to be responsible for this beneficial effect of eating fish. The two major omega-3 fatty acids found in fish are eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). DHA is an essential building block of the brain and nerve tissue. EPA may act to optimize the electrical signals between nerve cells and brain cells and may help the immune system to function well.
Some researchers have treated people who are already suffering from depression with fish oil. Some of these studies have shown a benefit for the fish oil treatment and others have not. These studies have tested EPA and DHA alone and in various combinations. Currently, it is not known whether EPA or DHA is more effective in preventing and treating depression. Some of the researchers involved in this study have learned how to identify mothers who are most at risk for developing depression during and after pregnancy. This study is designed to learn whether EPA-rich and DHA-rich fish oil supplements will prevent depressive symptoms in women who are at risk to develop depression.
- Conditions
- Depression
- Being tested
- EPA-rich fish oil supplement, DHA-rich fish oil supplement, placebo
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPA-rich fish oil supplementDrug
Also called ProEPA Xtra
1060 mg EPA plus 274 mg DHA
DHA-rich fish oil supplementDrug
Also called ProDHA
900 mg DHA plus 180 mg EPA
placeboDrug
control arm
| Study group | Role | What they receive |
|---|---|---|
| EPA-rich fish oil supplement | Active comparator | EPA-rich fish oil supplement Receives: Drug: EPA-rich fish oil supplement |
| DHA-rich fish oil supplement | Active comparator | DHA-rich fish oil supplement Receives: Drug: DHA-rich fish oil supplement |
| Soy Oil placebo | Placebo comparator | Soy oil Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory
The Beck Depression inventory scores depression based on 21 items, with a score of 0 - 3 on each item where 0 is no depression and a score of 31 or more is clinically depressed. The 21 items were summed to obtain the total score (The maximum possible score is 63.)
Measured: 6 - 8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2012
- Study completionJan 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 (9)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Ellen Mozurkewich, University of Michigan
- Investigators
- Ellen Mozurkewich, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711971
- Sponsor's protocol ID
- HUM00004684
- Other IDs
- R21AT004166-01A1
- Status last verified
- Mar 2017
- First submitted
- 7 Jul 2008
- Last updated
- 28 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Mozurkewich E, Chilimigras J, Klemens C, Keeton K, Allbaugh L, Hamilton S, Berman D, Vazquez D, Marcus S, Djuric Z, Vahratian A. The mothers, Omega-3 and mental health study. BMC Pregnancy Childbirth. 2011 Jun 22;11:46. doi: 10.1186/1471-2393-11-46.
PubMed 21696635Mozurkewich EL, Greenwood M, Clinton C, Berman D, Romero V, Djuric Z, Qualls C, Gronert K. Pathway Markers for Pro-resolving Lipid Mediators in Maternal and Umbilical Cord Blood: A Secondary Analysis of the Mothers, Omega-3, and Mental Health Study. Front Pharmacol. 2016 Sep 7;7:274. doi: 10.3389/fphar.2016.00274. eCollection 2016.
PubMed 27656142Williams JA, Romero VC, Clinton CM, Vazquez DM, Marcus SM, Chilimigras JL, Hamilton SE, Allbaugh LJ, Vahratian AM, Schrader RM, Mozurkewich EL. Vitamin D levels and perinatal depressive symptoms in women at risk: a secondary analysis of the mothers, omega-3, and mental health study. BMC Pregnancy Childbirth. 2016 Aug 3;16(1):203. doi: 10.1186/s12884-016-0988-7.
PubMed 27485050Romero VC, Somers EC, Stolberg V, Clinton C, Chensue S, Djuric Z, Berman DR, Treadwell MC, Vahratian AM, Mozurkewich E. Developmental programming for allergy: a secondary analysis of the Mothers, Omega-3, and Mental Health Study. Am J Obstet Gynecol. 2013 Apr;208(4):316.e1-6. doi: 10.1016/j.ajog.2013.01.024.
PubMed 23531329Mozurkewich EL, Clinton CM, Chilimigras JL, Hamilton SE, Allbaugh LJ, Berman DR, Marcus SM, Romero VC, Treadwell MC, Keeton KL, Vahratian AM, Schrader RM, Ren J, Djuric Z. The Mothers, Omega-3, and Mental Health Study: a double-blind, randomized controlled trial. Am J Obstet Gynecol. 2013 Apr;208(4):313.e1-9. doi: 10.1016/j.ajog.2013.01.038.
PubMed 23531328Ren J, Mozurkewich EL, Sen A, Vahratian AM, Ferreri TG, Morse AN, Djuric Z. Total Serum Fatty Acid Analysis by GC-MS: Assay Validation and Serum Sample Stability. Curr Pharm Anal. 2013;9(4):331-339. doi: 10.2174/1573412911309040002.
PubMed 25110470Berman D, Clinton C, Limb R, Somers EC, Romero V, Mozurkewich E. Prenatal Omega-3 Supplementation and Eczema Risk among Offspring at Age 36 Months. Insights Allergy Asthma Bronchitis. 2016;2(1):1. doi: 10.21767/2471-304X.100014. Epub 2016 Apr 10.
PubMed 28649675England JA, Jain J, Holbrook BD, Schrader R, Qualls C, Mozurkewich E. Effect of prenatal EPA and DHA on maternal and cord blood insulin sensitivity: a secondary analysis of the mothers, omega 3, and mental health study. BMC Pregnancy Childbirth. 2019 Nov 29;19(1):452. doi: 10.1186/s12884-019-2599-6.
PubMed 31783739Mozurkewich EL, Berman DR, Vahratian A, Clinton CM, Romero VC, Chilimigras JL, Vazquez D, Qualls C, Djuric Z. Effect of prenatal EPA and DHA on maternal and umbilical cord blood cytokines. BMC Pregnancy Childbirth. 2018 Jun 26;18(1):261. doi: 10.1186/s12884-018-1899-6.
PubMed 29940888
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does EPA or DHA Prevent Depressive Symptoms in Pregnancy and Postpartum?
- ClinicalTrials.gov ID
- NCT00711971
- Acronym / sponsor ID
- HUM00004684
- Conditions
- Depression
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 9 Jul 2008 (estimated)
- Results
- Posted 28 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to test whether an alternative medicine treatment, fish oil, will prevent depressive symptoms in pregnant and postpartum women who have been found to be at risk for depression. Epidemiologists have observed that people who live in countries where people on average eat a diet high in fish have a lower risk of depression than people who live in populations that eat less fish. Postpartum depression is also less common in these countries. The omega-3 fatty acids found in fish oil are thought to be responsible for this beneficial effect of eating fish. The two major omega-3 fatty acids found in fish are eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). DHA is an essential building block of the brain and nerve tissue. EPA may act to optimize the electrical signals between nerve cells and brain cells and may help the immune system to function well.
Some researchers have treated people who are already suffering from depression with fish oil. Some of these studies have shown a benefit for the fish oil treatment and others have not. These studies have tested EPA and DHA alone and in various combinations. Currently, it is not known whether EPA or DHA is more effective in preventing and treating depression. Some of the researchers involved in this study have learned how to identify mothers who are most at risk for developing depression during and after pregnancy. This study is designed to learn whether EPA-rich and DHA-rich fish oil supplements will prevent depressive symptoms in women who are at risk to develop depression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EPA-rich fish oil supplement | Active comparator | Drug: EPA-rich fish oil supplementEPA-rich fish oil supplement |
| DHA-rich fish oil supplement | Active comparator | Drug: DHA-rich fish oil supplementDHA-rich fish oil supplement |
| Soy Oil placebo | Placebo comparator | Drug: placeboSoy oil |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women who are more than 12 weeks pregnant but less than 20 weeks pregnant
- Women who are found to be at risk for depression
- Women who have been treated for depression in the past
- Women with depression after a previous pregnancy
- Women planning to deliver at University of Michigan Hospital
Key exclusion criteria (10 listed)
- Women who have major depression or other psychiatric disorders (current substance abuse, schizophrenia, bipolar disorder) at the time of screening
- Women who are currently taking anti-depressant or other psychiatric medications
- Women who routinely eat more than 2 fish meals per week
- Women on anticoagulants (blood thinners)
- Women currently taking omega-3 fatty acid dietary supplements (fish oil, flaxseed oil or cod liver oil)
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 |
|---|---|---|
| EPA-rich fish oil supplementAlso: ProEPA Xtra1060 mg EPA plus 274 mg DHA | Drug | EPA-rich fish oil supplement |
| DHA-rich fish oil supplementAlso: ProDHA900 mg DHA plus 180 mg EPA | Drug | DHA-rich fish oil supplement |
| placebocontrol arm | Drug | Soy Oil placebo |
Primary outcome
Beck Depression Inventory
Time frame: 6 - 8 weeks postpartum
The Beck Depression inventory scores depression based on 21 items, with a score of 0 - 3 on each item where 0 is no depression and a score of 31 or more is clinically depressed. The 21 items were summed to obtain the total score (The maximum possible score is 63.)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21696635Mozurkewich E, Chilimigras J, Klemens C, Keeton K, Allbaugh L, Hamilton S, Berman D, Vazquez D, Marcus S, Djuric Z, Vahratian A. The mothers, Omega-3 and mental health study. BMC Pregnancy Childbirth. 2011 Jun 22;11:46. doi: 10.1186/1471-2393-11-46.
- Results publication: PubMed 27656142Mozurkewich EL, Greenwood M, Clinton C, Berman D, Romero V, Djuric Z, Qualls C, Gronert K. Pathway Markers for Pro-resolving Lipid Mediators in Maternal and Umbilical Cord Blood: A Secondary Analysis of the Mothers, Omega-3, and Mental Health Study. Front Pharmacol. 2016 Sep 7;7:274. doi: 10.3389/fphar.2016.00274. eCollection 2016.
- Results publication: PubMed 27485050Williams JA, Romero VC, Clinton CM, Vazquez DM, Marcus SM, Chilimigras JL, Hamilton SE, Allbaugh LJ, Vahratian AM, Schrader RM, Mozurkewich EL. Vitamin D levels and perinatal depressive symptoms in women at risk: a secondary analysis of the mothers, omega-3, and mental health study. BMC Pregnancy Childbirth. 2016 Aug 3;16(1):203. doi: 10.1186/s12884-016-0988-7.
- Results publication: PubMed 23531329Romero VC, Somers EC, Stolberg V, Clinton C, Chensue S, Djuric Z, Berman DR, Treadwell MC, Vahratian AM, Mozurkewich E. Developmental programming for allergy: a secondary analysis of the Mothers, Omega-3, and Mental Health Study. Am J Obstet Gynecol. 2013 Apr;208(4):316.e1-6. doi: 10.1016/j.ajog.2013.01.024.
- Results publication: PubMed 23531328Mozurkewich EL, Clinton CM, Chilimigras JL, Hamilton SE, Allbaugh LJ, Berman DR, Marcus SM, Romero VC, Treadwell MC, Keeton KL, Vahratian AM, Schrader RM, Ren J, Djuric Z. The Mothers, Omega-3, and Mental Health Study: a double-blind, randomized controlled trial. Am J Obstet Gynecol. 2013 Apr;208(4):313.e1-9. doi: 10.1016/j.ajog.2013.01.038.
- Results publication: PubMed 25110470Ren J, Mozurkewich EL, Sen A, Vahratian AM, Ferreri TG, Morse AN, Djuric Z. Total Serum Fatty Acid Analysis by GC-MS: Assay Validation and Serum Sample Stability. Curr Pharm Anal. 2013;9(4):331-339. doi: 10.2174/1573412911309040002.
- Results publication: PubMed 28649675Berman D, Clinton C, Limb R, Somers EC, Romero V, Mozurkewich E. Prenatal Omega-3 Supplementation and Eczema Risk among Offspring at Age 36 Months. Insights Allergy Asthma Bronchitis. 2016;2(1):1. doi: 10.21767/2471-304X.100014. Epub 2016 Apr 10.
- Derived from this study: PubMed 31783739England JA, Jain J, Holbrook BD, Schrader R, Qualls C, Mozurkewich E. Effect of prenatal EPA and DHA on maternal and cord blood insulin sensitivity: a secondary analysis of the mothers, omega 3, and mental health study. BMC Pregnancy Childbirth. 2019 Nov 29;19(1):452. doi: 10.1186/s12884-019-2599-6.
- Derived from this study: PubMed 29940888Mozurkewich EL, Berman DR, Vahratian A, Clinton CM, Romero VC, Chilimigras JL, Vazquez D, Qualls C, Djuric Z. Effect of prenatal EPA and DHA on maternal and umbilical cord blood cytokines. BMC Pregnancy Childbirth. 2018 Jun 26;18(1):261. doi: 10.1186/s12884-018-1899-6.
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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.
Ellen Mozurkewich, MD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing EPA-rich fish oil supplement and DHA-rich fish oil supplement in people with Depression, run by University of Michigan 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 5 inclusion and 10 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 28 Apr 2017. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 28 Apr 2017). 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?
Beck Depression Inventory (time frame: 6 - 8 weeks postpartum). 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 NCT00711971, which also lists 9 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 28 Apr 2017.