Does Fish Oil Prevent Depression in Pregnancy and Postpartum?
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00711971 |
|
Recruitment Status :
Completed
First Posted : July 9, 2008
Results First Posted : April 28, 2017
Last Update Posted : April 28, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Depression | Drug: EPA-rich fish oil supplement Drug: DHA-rich fish oil supplement Drug: placebo | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 126 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Prevention |
| Official Title: | Does EPA or DHA Prevent Depressive Symptoms in Pregnancy and Postpartum? |
| Study Start Date : | September 2008 |
| Actual Primary Completion Date : | August 2012 |
| Actual Study Completion Date : | January 2013 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: EPA-rich fish oil supplement
EPA-rich fish oil supplement
|
Drug: EPA-rich fish oil supplement
1060 mg EPA plus 274 mg DHA
Other Name: ProEPA Xtra |
|
Active Comparator: DHA-rich fish oil supplement
DHA-rich fish oil supplement
|
Drug: DHA-rich fish oil supplement
900 mg DHA plus 180 mg EPA
Other Name: ProDHA |
|
Placebo Comparator: Soy Oil placebo
Soy oil
|
Drug: placebo
control arm |
- 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.)
- Maternal Outcomes [ Time Frame: visits at 26 - 28 weeks gestational age, 34-36 weeks gestational age during pregnancy and at the post partum visit 6- 8 weeks after delivery ]While the maternal outcomes assess criteria during pregnancy and relating to delivery they were assessed at visits 26 - 28 weeks gestational age, 34-36 weeks gestational age and at the post partum visit 6- 8 weeks after delivery.
- Gestational Age at Delivery (Weeks) [ Time Frame: delivery date was assessed by medical record review between 1 day and 8 weeks after delivery ]
- Estimated Blood Loss (ml) [ Time Frame: Within 24 hours after delivery ]
- Neonatal Birthweight [ Time Frame: immediately after birth ]Mean weight in grams: where <2500 gm is considered small for gestational age and >4500 gm is considered large for gestational age.
- NICU (Neonatal Intensive Care Unit) Admissions [ Time Frame: 6 weeks post delivery ]Admission to the NICU
- One Minute Apgar Score [ Time Frame: 1 minute after birth ]Apgar scores are based on a scale of 0 - 10 where 0 is a dead baby and 10 is an optimally vigorous newborn. The Apgar score analyzed here is the one minute Apgar.
- Five Minute Apgar Score [ Time Frame: 5 minutes after birth ]Apgar scores are based on a scale of 0 - 10 where 0 is a dead baby and 10 is an optimally vigorous newborn. The Apgar score analyzed here is the five minute Apgar.
- Cord Arterial pH [ Time Frame: Immediately after birth (collected within the first hour after delivery) ]Arterial blood gas analysis of umbilical cord blood
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00711971
| United States, Michigan | |
| University of Michigan Hospital | |
| Ann Arbor, Michigan, United States, 48109 | |
| Principal Investigator: | Ellen Mozurkewich, MD, MS | University of Michigan |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ellen Mozurkewich, Adjunct Assistant Professor, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT00711971 |
| Other Study ID Numbers: |
HUM00004684 R21AT004166-01A1 ( U.S. NIH Grant/Contract ) |
| First Posted: | July 9, 2008 Key Record Dates |
| Results First Posted: | April 28, 2017 |
| Last Update Posted: | April 28, 2017 |
| Last Verified: | March 2017 |
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |