CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 126 enrolled
Drug / intervention
EPA-rich fish oil supplement +2 moredrug
Likely dose
EPA-rich fish oil supplement 1060 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00711971
NCT00711971Phase 3Completed

Does EPA or DHA Prevent Depressive Symptoms in Pregnancy and Postpartum?

University of Michigan·interventional·Posted Jul 9, 2008·Updated Apr 28, 2017

In Brief

A Phase 3 clinical trial evaluating EPA-rich fish oil supplement, DHA-rich fish oil supplement, and 1 other intervention for Depression. Completed, enrolled 126 participants across 1 site.

Detailed 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. 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States

Timeline

Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 9, 2008
Enrollment StartSep 1, 2008
Primary CompletionAug 1, 2012
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 18.0 years ago

Interventions

EPA-rich fish oil supplementdrug

1060 mg EPA plus 274 mg DHA

DHA-rich fish oil supplementdrug

900 mg DHA plus 180 mg EPA

placebodrug

control arm