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NCT00711971 · ClinicalTrials.gov registry record · Phase 2

Does Fish Oil Prevent Depression in Pregnancy and Postpartum?

A Phase 2 study, sponsored by University of Michigan.

Completed
Registry status
Phase 2
Development phase
126
Enrollment target

NCT00711971: Completed Phase 2 study, sponsored by University of Michigan.

NCT00711971 is a Phase 2 study that has completed, run by University of Michigan. The registered enrollment target is 126 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00711971, a Phase 2 study, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
Phase 2
Development phase
126 participants
Enrollment target

Study 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.

Primary Outcome

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.)

Interventions

  • DRUG placebo
  • DRUG EPA-rich fish oil supplement
  • DRUG DHA-rich fish oil supplement

Trial Details

FieldValue
Enrollment Target 126 participants
Start Date 2008-09
Est. Completion 2013-01
Phase Phase 2
University of Michigan

1,327 total trials

What the finished NCT00711971 record still lists

NCT00711971 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.

NCT00711971 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00711971 about?

NCT00711971 is a clinical study titled "Does Fish Oil Prevent Depression 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 h...

What is the current status of trial NCT00711971?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 126 participants. The study started on 2008-09. Estimated completion is 2013-01.

What interventions are being tested in trial NCT00711971?

The interventions under investigation include: placebo (DRUG), EPA-rich fish oil supplement (DRUG), DHA-rich fish oil supplement (DRUG).

Who is sponsoring clinical trial NCT00711971?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00711971's enrollment target sits among peer trials

126 556th of 2000 higher than 1,443 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00711971, the US trial registry maintained by the National Library of Medicine. NCT00711971 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.