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NCT00361374 · ClinicalTrials.gov registry record · Phase 3

Safety and Effectiveness of Omega 3-Fatty Acids, EPA Versus DHA, for the Treatment of Major Depression

A Phase 3 study, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 3
Development phase
196
Enrollment target

NCT00361374: Completed Phase 3 study, sponsored by Massachusetts General Hospital.

NCT00361374 is a Phase 3 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 196 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00361374, a Phase 3 study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 3
Development phase
196 participants
Enrollment target

Study Summary

This study examines the difference in the effectiveness of two natural compounds, eicosapentanoic (EPA) and docosahexanoic (DHA)omega-3 fatty acids, in treating major depressive disorder. Both types of omega-3 fatty acids are commonly found in fish oils. It is believed that a deficiency in these omega-3 fatty acids may lead to the development of major depression.

Primary Outcome

Change in score on 17-item Hamilton D depression severity rating scale over 8 weeks of treatment. Scores were obtained every 2 weeks for 8 weeks. The total sum score of the 17 items is used to assess depressive severity. Possible total scores range from 0-52, with a higher score indicating greater depressive severity. Scores of 7 or less are indicative of full remission (i.e. no depression). Scores of 8-15 indicate mild depression; scores of 16-25 indicate moderate depression; scores of 25 or gr

Interventions

  • DRUG Placebo
  • DIETARY_SUPPLEMENT docosahexaenoic acid
  • DIETARY_SUPPLEMENT eicosapentaenoic acid

Trial Details

FieldValue
Enrollment Target 196 participants
Start Date 2006-07
Est. Completion 2013-03
Phase Phase 3
Massachusetts General Hospital

2,032 total trials

What the finished NCT00361374 record still lists

NCT00361374 is an interventional study that assigns participants to a tested intervention. The registered 196 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower).

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

NCT00361374 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00361374 about?

NCT00361374 is a clinical study titled "Safety and Effectiveness of Omega 3-Fatty Acids, EPA Versus DHA, for the Treatment of Major Depression". This study examines the difference in the effectiveness of two natural compounds, eicosapentanoic (EPA) and docosahexanoic (DHA)omega-3 fatty acids, in treating major depressive disorder. Both types of omega-3 fatty acids are commonly found in fish oils. It is believed that a deficiency in these ome...

What is the current status of trial NCT00361374?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 196 participants. The study started on 2006-07. Estimated completion is 2013-03.

What interventions are being tested in trial NCT00361374?

The interventions under investigation include: Placebo (DRUG), docosahexaenoic acid (DIETARY_SUPPLEMENT), eicosapentaenoic acid (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00361374?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00361374's enrollment target sits among peer trials

196 1390th of 2000 higher than 608 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00361374, the US trial registry maintained by the National Library of Medicine. NCT00361374 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.