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NCT00917501 · ClinicalTrials.gov registry record · Phase 2

Neurochemical Effects of Omega-3 Fatty Acids in Adolescents at Risk for Mania

A Phase 2 study, sponsored by University of Cincinnati.

Completed
Registry status
Phase 2
Development phase
55
Enrollment target

NCT00917501: Completed Phase 2 study, sponsored by University of Cincinnati.

NCT00917501 is a Phase 2 study that has completed, run by University of Cincinnati. The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00917501, a Phase 2 study, has completed, sponsored by University of Cincinnati.

COMPLETED
Registry status
Phase 2
Development phase
55 participants
Enrollment target

Study Summary

The purpose of this study is to see if taking a substance called omega-3 fatty acids is effective, safe, and well-tolerated for treating adolescents with major depressive disorder (also called simply "depression" or "clinical depression"). Another purpose of this study is to see how much omega-3 fatty acids are in a patient's blood and if that makes the patient more or less likely to develop mania (i.e. periods of irritability or extreme silliness accompanied by decreased need for sleep, risky behaviors, feeling like the patient has special abilities, inability to sit still, and rapid speech) in the future. Yet another purpose of this study is to see how taking omega-3 fatty acids affect brain scans. Omega-3 fatty acids are not United States Food and Drug Administration (FDA)-approved to treat depression in adults or in children and adolescents. Omega-3 fatty acids can only be obtained through diet, most often from fish and other sea foods, though they are also found in other food sources such as flax seed. Omega-3 fatty acids have been shown to play a role in affecting brain chemicals responsible for regulating mood and have been found to reduce symptoms of depression in medicated-patients with major depressive disorder. By completing this study, the investigators hope to better understand who benefits from treatment, why they do or do not respond to medications, and who is at greater risk for developing further mental illness. With this information, the investigators hope to be able to improve treatment and outcome in people with major depressive disorder.

Primary Outcome

Change in Children's Depression Rating Scale-revised (CDRS-R) Total Score from Baseline to 12 weeks CDRS-R score ranges from 17 (i.e., not depressed) to 113 (i.e., severe depression)

Interventions

  • DRUG Placebo
  • DRUG OMega 3

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2009-06
Est. Completion 2013-07
Phase Phase 2
University of Cincinnati

245 total trials

What the finished NCT00917501 record still lists

NCT00917501 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00917501 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00917501 about?

NCT00917501 is a clinical study titled "Neurochemical Effects of Omega-3 Fatty Acids in Adolescents at Risk for Mania". The purpose of this study is to see if taking a substance called omega-3 fatty acids is effective, safe, and well-tolerated for treating adolescents with major depressive disorder (also called simply "depression" or "clinical depression"). Another purpose of this study is to see how much omega-3 fat...

What is the current status of trial NCT00917501?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2009-06. Estimated completion is 2013-07.

What interventions are being tested in trial NCT00917501?

The interventions under investigation include: Placebo (DRUG), OMega 3 (DRUG).

Who is sponsoring clinical trial NCT00917501?

This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00917501's enrollment target sits among peer trials

55 1153rd of 2000 higher than 841 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 NCT00917501, the US trial registry maintained by the National Library of Medicine. NCT00917501 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.