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NCT00252486 · ClinicalTrials.gov registry record · NA

Omega-3 Fatty Acids in Children and Adolescents With Bipolar Disorder

A NA study of Bipolar Disorder, sponsored by University of Rochester.

Completed
Registry status
NA
Development phase
65
Enrollment target
1
Study location

NCT00252486 is a NA study of Bipolar Disorder that has completed, run by University of Rochester. The registered enrollment target is 65 participants, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00252486, a NA study of Bipolar Disorder, has completed, sponsored by University of Rochester.

COMPLETED
Registry status
NA
Development phase
65 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to test the hypothesis that flax oil, as an omega-3 fatty acid, will be superior to placebo in the maintenance treatment of bipolar disorder in children and adolescents. Our primary objective was to determine if flax oil is efficacious in the pediatric bipolar population for reducing symptoms of mania and depression. A secondary objective was to examine fatty acid levels as predictors of treatment response and symptom severity. This clinical trial evaluated whether supplementation with flax oil, containing the omega-3 fatty acid alpha-linolenic acid (alpha-LNA), safely reduced symptom severity in youth with bipolar disorder.

Conditions Studied

Bipolar Disorder

Interventions

  • DRUG Flax oil

Study Locations (1)

New York

  • University of Rochester - Rochester

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2001-11
Est. Completion 2005-06
Phase NA

Sponsor

University of Rochester

636 total trials

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What the Registry Record Tells You About NCT00252486

The ClinicalTrials.gov registry entry for NCT00252486 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (80% lower). The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 1 intervention - of which Flax oil is the first listed.

NCT00252486 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT00252486 about?

NCT00252486 is a clinical study titled "Omega-3 Fatty Acids in Children and Adolescents With Bipolar Disorder". The purpose of this study is to test the hypothesis that flax oil, as an omega-3 fatty acid, will be superior to placebo in the maintenance treatment of bipolar disorder in children and adolescents. Our primary objective was to determine if flax oil is efficacious in the pediatric bipolar populatio...

What is the current status of trial NCT00252486?

This trial is currently completed. It is a NA study. The enrollment target is 65 participants. The study started on 2001-11. Estimated completion is 2005-06.

What conditions does trial NCT00252486 study?

This clinical trial studies the following conditions: Bipolar Disorder.

What interventions are being tested in trial NCT00252486?

The interventions under investigation include: Flax oil (DRUG).

Who is sponsoring clinical trial NCT00252486?

This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00252486 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.